Institute of Good Manufacturing Practices India®

Global accredited training & certification provider

IGMPI Approvals & Accreditation : Approved by Quality Council of India (QCI) & Accredited Vocational Institution of Ministry of HRD, Government of India, Approved Training Institute of Food Safety and Standards Authority of India (FSSAI), Recognized by Department of Industrial Policy & Promotion, Ministry of Commerce & Industry, Government of India, An ISO 9001:2015 Certified Organisation registered under The Societies Registration Act,1860 Government of India Empanelled under Ministry of Horticulture and Food Processing, Government of Uttar Pradesh, Affiliated with Life Sciences and Food Industry Sector Skills Council (SSC)
Trusted by organizations & training participants in over 30 countries. Training | Certification | Education | Research

GLOBALG.M.P.™ Newsletter

23rd July 2019

Complete compliance followed in Patanjali; denial receiving USFDA notice
Baba Ramdev said that company follows complete compliance as per the ayurvedic specifications of India and US. The company has zero-tolerance policy in response to quality concerns.

22nd July 2019

USFDA said Patanjali’s sharbat bottles contains different dietary, medical claims
According to the USFDA, the labels on Patanjali’s two sharbat bottles, sold within India, were found to be having “additional medicinal and dietary market claims” as compared to the ones meant for export to America. They also found out that the production and packaging area for exported products is separate from the domestic products.

20th July 2019

7 USFDA Observations to Cipla's Bengaluru API Unit
The USFDA has issued seven observations to the Bengaluru facility of Cipla. A routine cGMP inspection was carried out by the USFDA to the API facility of Cipla based at Bengaluru.

16th July 2019

Strides Pharma Warned by FDA over Uncontrolled Document Shredding
Earlier this month, the USFDA warned Indian generic drugmaker Strides Pharma over good manufacturing practice (GMP) violations at its Pondicherry facility. uncontrolled shredding of documents and inadequate investigations in out-of-specification (OOS) test results were some the major violations observed by the USFDA inspectors.

15th July 2019

Indoco Remedies received warning letter for oral dosage plant
The US FDA warning letter is issued to Indoco Remedies for its Oral Dosage Plant-1, Goa following an inspection in January 2019. The facility has classified as Official Action Indicated (OAI) in March 2019 after receiving Form 483 with 6 observations. The remediation activities for the observations is still going on in the facility.

15th July 2019

NATCO pharma completes US FDA inspection with zero observations
The Natco pharma has successfully completed with the US FDA audit of their Chennai based facility. The audit was done for the active pharmaceutical ingredient facility between 8 July-12 July 2019.

12th July 2019

5 US FDA Observations to Hyderabad plant of Dr Reddy’s
A form 483 stating the objectionable conditions was issued to Dr. Reddy’s laboratory plant based at Hyderabad. The US FDA has audited their active pharmaceutical ingredient (API) manufacturing plant 2 at Bollaram, Hyderabad resulting into form 483 with 5 observations.

12th July 2019

US FDA nod to Laurus Labs
The Laurus Labs has successfully completed the US FDA audit of their Visakhapatnam’s Unit 4 facility without any Form 483. The audit was done between 8 July – 12 July 2019.

09th July 2019

Revised REMS Modification Guidance Finalized by FDA
The US FDA finalized a revised guidance on making and submitting modifications and revisions to risk evaluation and mitigation strategies (REMS), including what types of changes FDA will consider and processes and procedures for submitting those changes to the FDA.

09th July 2019

Akron warned for repeated Violations
The US FDA released a warning letter for Akron’s Somerset, New Jersey manufacturing facility due to the violations of cGMP. The letter included all the observations the FDA inspection team made during their one-month inspection last month.

09th July 2019

FDA to Pull 31 Apotex ANDAs Due to Manufacturing Concerns
The US FDA announced that they are withdrawing the approval of 31 abbreviated new drug applications (ANDAs) held by Apotex after they found the manufacturing deficiencies at two of the company’s plants.

02nd July 2019

USFDA Warning letter to Aurobindo
Indian Drug maker, Aurobindo Pharma received a warning letter from the FDA about violations of good manufacturing practice (GMP) at one of the company’s facilities in Srikakulam District, Andhra Pradesh following a six-day inspection in February.

20th June 2019

Voluntary Recall of All Sterile Products Issued by Infusion Options Inc.
Infusion Options Inc. has decided to recall all sterile products lots within expiry date due to lack of sterility assurance. Till date, the company has not received any adverse event report but administration of sterile products whose sterility is not assured can be life-threatening.

14th June 2019

Adulterated products from Life Rising Corporation seized by FDA officials
More than 300,000 dietary supplement containers, including tablets, capsules and teas from Life Rising Corporation were seized by the U.S. FDA officials. The products were seized from company’s Willowbrook, Illinois, manufacturing facility, consisted of hundreds of goods bearing brand names Holicare, or Life Rising, and their value is around $3.5 million.

11 June 2019

Taiwan Drug manufacturer gets the US FDA warning over GMP violations
The US FDA warned Taiwan-based Drug manufacturer, Vida International following an inspection at Taoyuan city facility last December over GMP non-compliance and placed Vida on import alert in March. In the warning letter, the US FDA states that Vida has not conducted batch testing for one of its products before release.

22 May 2019

Curam Duo 400-57 Recall: TGA Australia
The TGA Australia has instructed Sandoz Australia to recall two batches of Curam Duo 400/57- JC5418 and JC5419. Curam Duo contains amoxicillin and potassium clavulunate. It is an oral suspension in powder form which is used to treat bacterial infections in children and adults.

21 May 2019

Liver injury risk leads to Hairpro capsules and hair tonic recall
A safety investigation done by the TGA Australia results in the recall of Oriental Botanicals Hairpro capsules and Fusion Hair Tonic because of liver injury risk.

07 May 2019

Warning letter for cGMP non-compliance to Canadian OTC manufacturer
Petra Hygienic Systems Int. Ltd. received US FDA warning letter for violating cGMP practices. Their facility based in Concord, Ontario was failed to validate outsourced material and test products for the strength and identity of API. They also did not have appropriate written cleaning procedures in place.

03 May 2019

Two more EU countries GMP inspections accepted: FDA
It has been accepted by the FDA that two more European Union countries are competent to perform cGMP inspections of manufacturing sites for human medicines. Cyprus and Bulgaria are the two countries which have been included in the mutual recognition agreement between the USA and the EU. Now, total 24 EU member states can perform the inspections which will be equivalent to that of the FDA and can be replaced.

22 March 2019

Alkem's Product Approval withhold by USFDA
A pre approval inspection was done at St. Louis manufacturing of Alkem Dated 06 February 2019.

18 March 2019

FDA AUDITS IN INDIA AND OAI
Inspection standards of the FDA were same since last 15 years, only the audit frequency has changed. The number of FDA inspections has increased in recent years due to several reasons such as more applications for Abbreviatived New Drug Applications which demand inspection for each filing and GDUFA fee where applicants pay to FDA to get the inspection done. It has been observed that Indian companies are not improving their quality even after getting observations from FDA.

06 March 2019

Form 483 to Biocon, Bengaluru facili
USFDA has given 6 observations in Form 483 to Biocon followed by its Bengaluru plant inspection. A New Drug Application for insulin was submitted by the firm to FDA. Approval of which requires pre-inspection audit resulting into these six observations.

06th March 2019

Roorkee facility of Jubilant Life Science gets warning letter from USFDA
A warning letter has been issued to Jubilant Life Sciences, Roorkee facility based in Uttarakhand. It has been told by the officials of Jubilant Life Sciences that this warning letter can leads to withhold of several new application approvals until all the issues will be addressed by the company. The inspection was done from 30 July 2018 to 08 August 2018. cGMP regulations with respect to finished pharmaceuticals were violated at the facility as per FDA officials.

06 March 2019

Roorkee Facility of Jubilant Life Science gets warning letter from USFDA
A warning letter has been issued to Jubilant Life Sciences, Roorkee facility based in Uttarakhand. It has been told by the officials of Jubilant Life Sciences that this warning letter can leads to withhold of several new application approvals until all the issues will be addressed by the company. The inspection was done from 30 July 2018 to 08 August 2018. cGMP regulations with respect to finished pharmaceuticals were violated at the facility as per FDA officials.

04 March 2019

Warning letter issued to Hospira, India Facility
Data integrity issues along with cGMP violations in Hospira, India facility leads them to receive a warning letter by FDA Dated 04 March 2019. FDA inspected the Tamil Nadu’s Hospira facility from 27 March to 03 April 2018. Several cGMP violations have been observed during the inspection ranging from data integrity issues to unacceptable batch failure investigations.

28th February 2018

USFDA warning letter to Anicare Pharmaceuticals
The FDA inspection at Navi Mumbai facility of Anicare Pharmaceuticals was done during 30 July 2018 to 03 August 2018. The company has received warning letter following this audit due to cGMP violations at their facility for finished pharmaceuticals.

18th December 2018

Draft Guidance on Good practices for Integrity and Data Management framed by PIC/S
The Pharmaceutical inspection convention/Pharmaceutical inspection cooperation scheme (PIC/S) has released a draft guidance of 53 pages describing that how an inspector should examine facilities that must follow Good Manufacturing Practices (GMP) and Good distribution practice (GDP). This draft was released keeping in mind the violations of data integrity that are continuously found in FORM 483s and warning letters.

18th December 2018

Regulatory action after Jubilant Life’s Roorkee Plant survey suggested by USFDA
As per a regulatory filing, a supervisory action has been suggested by US health regulator after completion of the examination of Roorkee manufacturing facility of drug firm Jubilant Life Sciences.

18th December 2018

Guidelines on quality of water for pharmaceutical use published by EMA
Draft guidance has been published by EMA on quality of water that has to be used for the pharmaceutical purpose. This draft will provide direction to the industry. This draft is aimed at providing knowledge about the pharmaceutical utilization of different grades of water used in manufacturing medicinal product and active substances for veterinary and human use. The methods which are parallel to the water distillation will be included in this draft.

18th December 2018

USFDA EIR obtained by Lupin for unit 3 of the Pithampur facility
An EIR (Establishment Inspection Report) form the U.S regulator has been received for unit 3 facility in Madhya Pradesh of Lupin limited, which is a multinational pharmaceutical company based in Mumbai.

06th December 2018

Biocon's Bengaluru Plant's Inspection Completed By Usfda
The inspection of the new manufacturing facility of Biocon was completed by USFDA without any findings.

06th December 2018

Alkem Lab Taloja Facility’s Inspection By Usfda Comes To An End
Review of Alkem Lab's Bioequivalence facility located at Taloja in the state of Maharashtra has been completed by USFDA (United State Food and Drug Administration) from 8th to 14th November 2018. No form 483 was issued at the end of it.

23rd November 2018

GMP Violation noted by FDA at US vascular medical device manufacturing unit
As per the reports, during an inspection of US vascular's medical device manufacturing facility at Beaverton by US FDA, there have been 11 contraventions of good manufacturing practices, as per a FDA warning letter.

15th November 2018

ICH Q13: Continuous Manufacturing of Drug Substances and Drug Products
Continuous manufacturing can improve manufacturing of drug products and drug substances. However, its commercialization is challenging due to insufficient regulatory guidelines. Therefore, development of ICH guideline could support in minimizing such barriers. This can help in development of common regulatory concepts, definitions, processes, etc. Q13 final concept paper regarding continuous manufacturing was enforced Dated 15 November 2018. The new guideline will address regulatory expectations such as site implementation, post-approval changes and quality systems.

14th November 2018

ICH Q14: Analytical Procedure Development and Revision of Q2 (R1) Analytical Validation
Final concept paper regarding ICH Q14 was issued dated 14 November 2018. It has been proposed that Q2 (R1) must be revised along with development of a new guideline based on development of Analytical Procedure. This can help in harmonization of requirements and improvise the communication amongst regulators and industry. Harmonization is required for several scientific and technical elements involving development of analytical procedure and its submission along with required information in CTD format.

14th September 2018

Warning Letter issued by USFDA to subsidiary of Zimmer Biomet Holdings Inc. for cGMP violations
Zimmer Biomet has received warning letter from USFDA for its North Campus manufacturing facility located in Warsaw Indiana due to current good manufacturing practice non-conformities of its quality system.

14th September 2018

USFDA issued form 483 to Halol Facility of Sun Pharma on account of cGMP violations
Sun Pharma's Halol Facility located in Gujarat has received form 483 on account of cGMP violations. The USFDA conducted a pre-approval inspection (PAI) of the Halol facility and found non-compliance with cGMP regulations. The inspection was carried out from 27th August 2018 to 31ST August 2018.

14th September 2018

USFDA released an internal procedure on prioritization of inspection of manufacturing facilities
An internal Manual of Policies and Procedures called MAPP had been released by USFDA which reveals how pharmaceutical manufacturing sites are prioritized and selected for surveillance inspections.

14th September 2018

The Lupin’s Tarapur API facility received one observation on account of cGMP deficiency
Lupin is India’s third largest drug manufacturing company. The Tarapur API manufacturing facility of Lupin has received one observation by USFDA. The Tarapur facility produces fermentation based APIs.

14th September 2018

Anti-rabies vaccine from China recalled by USFDA on account of cGMP issues
All batches of an-anti rabies vaccine imported from Jilin province in China have been recalled by USFDA after the National Medical Products Administration of China found that the anti-rabies vaccine manufacturer, Changchun Changseng Life Sciences Ltd violated relevant requirements of GMP. Mainly data integrity issues were observed.

14th September 2018

Recall of hypertension drug bottles from US by Hetero Labs on account of cGMP issues
Hetero Labs is recalling over 15.90 lakh bottles of Valsartan Tablets USP in the strengths of 40 mg, 80 mg, 160 mg and 320 mg from US market due to deviations from good manufacturing norms. The tablets were manufactured by the company for Camber Pharmaceuticals Inc.

06 July 2018

Guidance on Good Manufacturing Practice for APIs finalized by FDA
The FDA has finalized the guidance on Good Manufacturing Practice (GMP) for active pharmaceutical ingredients (APIs) which is based on the International Conference on Harmonization (ICH Q7) guidelines. The revised guideline is based on question and answer format so that responses can be provided to requests for clarification of uncertainties due to interpretation of certain sections in the ICH guidance.

06 July 2018

Draft guidance released by FDA on Product tracing requirements
A draft guidance namely “Standardization of Data and Documentation Practices for Product Tracing" has been released by FDA to help trade partners in standardizing the data needed for ensuring the traceability of products.

06 July 2018

First sANDA (Supplemental Abbreviated New Drug Application) approved by USFDA for Glenmark Pharmaceuticals Manufacturing Facility In Monroe, North Carolina
Glenmark Pharmaceuticals Ltd. (GPL) is a global innovative pharmaceutical company with presence in more than 50 countries and has a diverse pipeline with several compounds in various stages of clinical development, primarily focused in the areas of oncology, respiratory disease and dermatology.

06 July 2018

FDA form 483 issued to Mylan Pharmaceuticals' manufacturing facility in Morgantown, WV for lapses in quality control
Mylan Pharmaceuticals' manufacturing facility in Morgantown, WV, received an FDA Form 483 due to lapses in quality control and GMP violations. The FDA inspection of the site took place earlier this year and it was a 12 day inspection.

06 July 2018

EIR (Establishment Inspection Report) received by Sun Pharma for its Halol Facility in Gujarat
The Halol manufacturing Facility of Sun Pharma was inspected way back in September 2014 by three USFDA inspectors Parul Patel, Daniel Roberts and Thomas Arista who began inspection of the facility on September 8, 2014 which continued till September 19, 2014 leading to 23 observations and 19 page Form 483.

06 July 2018

Henan Lihua Pharmaceutical Co. Ltd. Warned for GMP violations by USFDA
Henan Lihua Pharmaceutical Co. Ltd is a Chinese Active Pharmaceutical Ingredient manufacturer which produces steroid and hormone APIs and is GMP-certified by regulators in the EU, US and China. The US Food and Drug Administration (FDA) has conducted the inspection of the company last December in which they found GMP violations and data integrity issues and therefore has given warning letter to the company.

06 July 2018

Chennai based BCG vaccine Laboratory to restart manufacture of multi-dose vials of anti-tuberculosis
Chennai based BCG Vaccine Laboratory has applied to the directorate of drugs control for a commercial licence to restart manufacture of multi-dose vials of anti-tuberculosis after the experiment batches of the anti-tuberculosis vaccine manufactured in the company’s new building were declared consistent and of standard quality by the Central Drugs Laboratory in Kasauli. Six batches of the vaccine manufactured between January and March were tested and found to be of standard quality.

06 July 2018

Inspection by USFDA completed at Zydus Cadila,Ahmedabad plant
Zydus Cadila is headquartered at Ahmedabad in Gujarat and is the fourth largest pharmaceutical company in India. It was founded in 1952 by Ramanbhai Patel, formerly a lecturer in the L.M. College of Pharmacy and his business partner Indravadan Modi. However in 1995, the Patel and Modi families split and Modi Family’s share moved into a new company called Cadila Pharmaceuticals Ltd. and Cadila Healthcare.

06 July 2018

USFDA issued warning letter to IDT Australia Limited’s facility on account of GMP violations
Warning letter has been issued by USFDA to the Australian pharmaceutical company and contract development and manufacturing organization (CDMO) IDT Australia due to GMP violations. IDT Australia makes APIs and finished drug product s for clients. The company’s Boronia facility, Victoria was inspected by FDA in December 2017.

11th June 2018

Pharma companies marketing medicines made by third parties in India shall be liable for any quality issues as per CDSCO
A proposal was approved by The Drugs Technical Advisory Board (DTAB) recently to amend the Drugs & Cosmetics Act to make pharmaceutical marketing firms accountable for any violations of the regulations which means that companies marketing medicines in India will soon be as liable as the manufacturers for any violations of drug regulations that could lead to spurious or substandard medicines.

11th June 2018

Two additional EU member states join EU-US Mutual Recognition Agreement to carry out Good Manufacturing Practice
Two additional EU member states -Lithuania and Ireland have joined The US Food and Drug Administration (FDA) to carry out Good Manufacturing Practice inspections at a level equivalent to the US as confirmed by European Medicines Agency (EMA).

11th June 2018

Draft Guideline for Handling and Shipping Investigational Medicines proposed by EMA opened for public consultation
Two additional EU member states -Lithuania and Ireland have joined The US Food and Drug Administration (FDA) to carry out Good Manufacturing Practice inspections at a level equivalent to the US as confirmed by European Medicines Agency (EMA).

11th June 2018

Complaint filed against two stem cell clinics by FDA in Federal Court
FDA requires the stem cell treatments to be studied under an Investigational New Drug (IND) application and has discretion to approve and give a go ahead only on the basis of how the product is manufactured to ensure appropriate steps are being taken to assure the product’s safety, purity, and strength.

11th June 2018

Inspection of JB Chemicals and Pharmaceuticals manufacturing facility at Panoli, Gujarat completed by USFDA
J B Chemicals and Pharmaceuticals API manufacturing facility at Panoli, Gujarat has successfully passed periodical inspection by US Food and Drug Administration (USFDA). This US FDA/EU/Japan approved API facility primarily manufactures APIs for exports to EU and formulations exports to US.

23rd May 2018

Reine Lifescience gets US FDA warning letter for contravention of cGMP norms for APIs
Warning letter has been issued to Reine Life science by US Food and Drug Administration (FDA) on May 9, 2018. Reine Lifescience is a manufacturer of Active Pharmaceutical Ingredients (APIs) located in Gujarat.

24th February 2018

Indian Pharma Stands Strong in Global markets
In the Year 2017, Indian pharma companies received 29% USFDA warning letters as compared to 50% in the year 2015. The Indian pharma companies register marked improvement in quality standards and regulatory compliance.

24th February 2018

UK MHRA Suggests Little Changes to Regulatory Framework
The MHRA (Medicines and Healthcare products Regulatory Agency, UK) has released letter on the negotiations between the EU and the UK which have now in second phase.

24th February 2018

Violation-of-GMP-Principles-at-Indian-API-Manufacturing-Unit
Inspectors from Danish Medicines Agency inspected the facilities of Kadam Exports Private Ltd , an Indian API Manufacturers. The audit revealed severe deficiencies in the compliance with the GMP rules in virtually all areas. The active substance under scrutiny was Psyllium husk, a dietary and herbal medicinal product.

24th February 2018

Health-ministry-constitutes-DTAB-sub-committee-to-re-examine-banneds
Under the Government of India’s Union Health Ministry, a sub-committee is formed to examine the banned 344 FDCs + 5 FDCs as per the directions of the Supreme Court of India. The sub-committee will be headed by Dr NilimaKshirsagar

17th January 2018

Collaboration between US FDA and Gujarat FDCA to Implement Joint Project
Among top three aspects for collaboration- knowledge sharing, capacity building and raising compliance levels, the Gujarat Food and Drug Control Administration (FDCA) is planning to meet US Food and Drug Administration (FDA) officials.

17th January 2018

India reports quality shortcomings of Chinese pharma companies
In response to shortcomings Indian government has issued a showcause notices to eight Chinese pharmaceutical companies. Those companies were inspected by a special Indian inspection team and were found to supply poor quality APIs to drug manufacturers in India.

17th January 2018

European Inspector Found Cleaning and Process Validation Deficiencies
US FDA publishes GMP deficiencies in their warning Letter in Form 483. In European Union, there is a European portal, where non-compliance results are published.

17th January 2018

Missing Tests for Identity lead to FDA Warning Letter
A Canadian manufacturer, Cellex-C International, Inc received a FDA Warning Letter issued on August, 2017 basis an FDA inspection.The inspection team lamented that not all batches of the manufactured drug product and the active substances used therein had been tested for compliance with the specifications before their release. According to the response given by Cellex-C, the tests had been performed by a contract laboratory.

28th December 2017

The Maharashtra FDA Issues Suspension of Licenses Basis Non-Compliance
Over the past six months, Maharashtra Food and Drug Administration (FDA) has cancelled 278 retail licenses and suspended 1,439 licenses across the state for non-compliance to Drugs and Cosmetics Act. This action is an outcome of state drug regulator’s routine inspections on drug retail shops and 2908 wholesale inspections.

28th December 2017

Dr. Reddy’s exhibits promising growth prospects as regulatory concerns subside
In the last one-two years Dr. Reddy’s Laboratories Ltd has faced deteriorating earnings profile, however, the scenario now seems to improve due to easing regulatory concerns and expected launch of certain high-value products in the US.

28th December 2017

Long Awaited Draft to Annex 1 on Sterile Manufacturing Published
The European Commission has released the long awaited draft of Annex 1 “Manufacture of Sterile Medicinal Products”. The draft is open for public consultation from 20 December 2017 until 20 March 2018.

28th December 2017

Non-Compliance ASU&H Drug Manufacturers
In a statement released by Government of India, out of 8,667 licenced Ayurvedic, Siddha, Unani and Homoeopathy (ASU&H) drug manufacturers in the country, 1179 are reported to be non-compliant with the prescribed Good Manufacturing Practices (GMP).

16th December 2017

Biocon, Mylan Gets US Approval for Ogivri- Biosimilar for Trastuzumab
US Food and Drugs Administration (USFDA) have provided approval to Biocon and Mylan for its biosimilar Herceptin or trastuzumab, Ogivri. Ogivri has been approved for all indications included in the label of the reference product, Herceptin.....

16th December 2017

Glenmark is Served With Form 483 at its Baddi Plant, Himachal Pradesh
The US Food and Drugs Administration (FDA) has served Glenmark, an Indian manufacturer, Form 483 citing observations relating to violation of good manufacturing practices which the inspectors noticed while inspecting the Baddi Plant.

16th December 2017

GMP Deficiencies in Vital Laboratories Limited
In pharmaceutical Industry, GMP violations are unacceptable and depict a manufacturer’s lax handling of deviations, insufficient monitoring and documentation of critical process steps as well as their ignoring of OOS results in quality control. In April 2017, FDA inspectors were confronted with these violations when they visited the production site of an Indian manufacturer Vital Laboratories Private Limited

16th December 2017

German Regulatory Agency Permits Dr Reddy’s Visakhapatnam Plant to Restart Exports to EU
In a recent development, Reddy’s Laboratories Ltd has got permission from German regulatory authority for its Visakhapatnam plant to restart production for the European market (EU). The corrective and preventive action plan (CAPA) submitted by Dr. Reddy’s has been well accepted by the regulator. Consequently, the regulator has permitted production to start again from this facility for the EU market. However, an inspection will be conducted by the regulator by the end of 2018.

16th December 2017

European Medicine Agency’s New Location: Amsterdam
The European Medicines Agency (EMA) will relocate to Amsterdam in the Netherlands. This decision was taken after the voting of EU 26 Member States. The Agency now has just over 16 months to prepare for the move and take up its operations in Amsterdam on 30 March 2019 at the latest.

16th December 2017

New GMP Guidelines for Advanced Therapies Released by European Commission
The European Commission has published a set of guidelines on good manufacturing practice (GMP) specific to advanced therapy medicinal products (ATMPs). New advanced medicinal therapies are based on medicines for human use that involve genes or cells. These therapies offer ground-breaking new.

06th October 2017

DIVI’s LABS gets USFDA FORM 483
Following inspection of Unit-2 at Vishakhapatnam for API manufacturing, USFDA has found more problems at Divi’s Laboratories Limited that was earlier banned from shipping to the US in March 2017......

06th October 2017

EMA releases Question/ Answer document to lift a non-compliance statement
New process has been outlined by The European Medicines Agency (EMA)on lifting a GMP non-compliance statement. The new process will facilitate understanding on how to proceed further following a receipt of non-compliance certificate on GMP of the EMA.

06th October 2017

Pharma Exports are led by Gujarat with highest number of 280 WHO-GMP certified manufacturing units followed by Maharashtra
Gujarat has achieved the distinction of having the highest number of 280 WHO – GMP certified manufacturing units in the country followed by Maharashtra with 222 units, Himachal Pradesh at 134, Telangana at 131 and Uttarakhand at 97.

09th September 2017

DRL’s Bachupally unit failed to get GMP Nod from German Regulator
Dr Reddy’s Laboratories Bachupally Unit 2 failed to get Good Manufacturing Practices (GMP) compliance certificate from German Regulator. Only this time it has run afoul of the German regulator Regulatory Authority of Germany (Regierung von Oberbayern)......

09th September 2017

Maharashtra FDA cancels 58 MFG licenses and suspends 145 licenses for GMP non-compliance
In a recent attempt to scrutinize and curb malpractices in Good Manufacturing Processes, Maharashtra FDA cancelled 58 manufacturing licenses and suspended 145 licenses of manufacturing units across the state since April 2016 till date The strict action taken by Maha FDA is response to malpractices followed

09th September 2017

DCGI demands stability data for Non-Patented and Proprietary Drugs
In order to maintain quality of drugs, the Drugs Controller General of India (DCGI) has directed all the drug manufacturers to submit the stability data of non-patent and proprietary medicines. At the time of submission of application for grant of permission to manufacture medicines, the manufacturer will now submit stability data of non-patent and proprietary

09th September 2017

Hetero Labs gets USFDA Warning Letter
Hyderabad based Hetero labs received a warning letter from US FDA for serious violation of current Good Manufacturing Practices (cGMP) following an inspection at its Jadcherla facility in Telangana. USFDA inspection occurred between December 07 2016 to

09th August 2017

USFDA Issues Form 483 to Biocon’s Bengaluru Unit
Form 483 listing violations in current Good Manufacturing Plant (cGMP) have been issued by USFDA to Biocon following an inspection between May 25 and June 03 2017. USFDA noticed 10 observations in Biocon’s small molecule injectable plant in Bengaluru.....

09th August 2017

MRA expands between Japan and EU
Mutual Recognition Agreement (MRA) between Japan and EU in the area of good manufacturing process (GMP) has been amended besides working on other sections of Economic Partnership agreement. The new agreement will expand to new pharmaceutical products. Following the finalization of the MRA, the extended scope would include active pharmaceutical ingredients (APIs), biologics, vaccines and immunologicals.

09th August 2017

Lupin Ltd Successfully Completed USFDA Inspection
In an official statement, Lupin released information about USFDA inspection in its unit at Pithampur plant in Madhya Pradesh. Inspection on Good manufacturing Practices (GMP) at Unit 1 of the company’s Pithampur facility was successfully completed and it received PAI (Prior Approval Inspection) by USFDA. No observations were noted during the inspection.

09th August 2017

CDSCO Trains New Drug Inspectors in Linewith Global Standards
The Central Drug Standards Control Organization (CDSCO) has trained 100 drug inspectors and is in process of training 85 assistant drug inspectors on auditing manufacturing units for Good manufacturing Practices(GMP) across the country. India exports to around 200 countries across the globe and to ensure the quality of products, it is important to increase the inspections and audits

09th August 2017

Equipment design as per GMP complaince
GMP-compliant equipment design is gaining lot of expert’s interest as it will be more suitable for the manufacturing of medicinal products/APIs. Consequently, the only feature an equipment design should have is: system has to be qualifiable. ....

09th August 2017

USFDA issue form 483 to INTAS Pharma’s Moraiya Biotech Unit
Following a USFDA inspection, Intas Pharmaceuticals Limited’s biotech facility at Moraiya in Gujarat received quality warning. FDA issued a FORM 483 with 14 observations relating to good manufacturing practices. FORM 483 is issued to a company in case of any deviations from US Food Drug and Cosmetic (FD&C) Act and related acts. Following are observations from FDA inspectors:

08th July 2017

New Rule for APIs from UK: Need Written Confirmation
As per the Brexit: UK is now established as the ‘Third Country’ and the European Medicines Agency (EMA) and the European Commission intend to provide a series of Brexit related Questions and Answers on the consequences for the pharmaceutical industry.

08th July 2017

FDA Warning Letter: Sampling Plans and Strategies
Recently, FDA emphasized on lack of scientifically sound and appropriate sampling plans for inspection by releasing a warning letter. The warning letter underlines the lack of Company’s scientific justification for the number of reserve samples selected for the yearly visual examination.

08th July 2017

Falsified Harvoni® entered German Supply Chain/S
The German Regulatory Agency ,BfArM (BundesinstitutfürArzneimittel und Medizinprodukte, the German Federal Institute for Drugs and Medical Devices),stated in a press release that a counterfeit pack of Gilead Sciences’ hepatitis C drug Harvoni has entered the legal supply chain in Germany.

08th July 2017

Chinese FDA Releases Report on International Inspections
Chineese “Annual Report of Drug Inspection 2016” has been published by China Food and Drug Administration (CFDA). The report summarizes the results of inspections performed by CFDA in China. Additional report gives an overview of international inspection activities.

08th July 2017

CGMP Guidance for Medical Gases
Earlier medical gases were regulated as pharmaceuticals. Considering its nature and properties, FDA has published new guidelines for the current good manufacturing practices (CGMP) for the manufacturing of medical gases. The guidelines were developed to provide

08th July 2017

Approval for Anti-inflammatory drug of Glenmark Pharmaceuticals
USFDA has granted final approval to Glenmark Pharmaceuticals for its generic version of anti-inflammatory drug Indomethacin tablet. The dosage of Indomethacin Tablet for which Glenmark Pharmaceuticals received USFDA approval is extended release capsule of 75 mg strength.

08th July 2017

European Union frames New Action Plan on Antimicrobial Resistance as ‘One Health Vision’
Europe is considered the world’s best practice region in the field of Antimicrobial Resistance (AMR). Best practices in the world on AMR are to be found in Sweden, the Netherlands, the UK and Denmark - particularly Denmark has had great success in cutting overuse of antibiotics in farm animals - and Norway for fisheries..

08th July 2017

ZydusCadila and NatcoPharma received marketing approval from USFDA
ZydusCadila received United States of Food & Drug Administration (USFDA) approval to launch Entecavir Tablets in the two dose strengths -0.5 mg and 1 mg. The drug Entecavir is generic version which is used to treat Hepatitis B viral infection. The estimated sale as per IMS data is $166.3 million in US markets.

26th May 2017

FDA Issued Warning Letter to Vikshara Trading and Investments Ltd
FDA issued a Warning Letter and an import alert to Vikshara Trading & Investments Ltd, an Ahmadabad based manufacturing facility. During the inspection, FDA investigators were stopped from inspecting the facility. ....

26th May 2017

Reorganization of FDA’s ORA structure
Main aim of US Food and Drug Administration’s is to protect public health. To attain this FDA has to keep an update on new developments in sciences and globalization. Therefore, FDA has set up an alignment programme which helps strengthen the authority.

26th May 2017

Markson Pharma received GMP compliance certificate from TGCA/S
Marksans Pharma, a generic drug manufacturing company has received a certificate of good manufacturing practice (GMP) compliance from the Australian drugs and devices regulator for its Verna facility in Goa.

26th May 2017

GMP Deficiency Data- A trend published by MHRA
An yearly report on inspection deficiency findings has been published by the GMDP Inspectorate of the British MHRA (Medicines & Healthcare products Regulatory Agency). This time the method of data collection has been improved, thus introducing new data trending.

26th May 2017

Biosimilar Interchangeability Guidance- An FDA Approach
Since January 2017, the FDA was working on long-awaited Biosimilar Interchangeability Guidance for public. The guidance provide information on biosimilar interchangeability. Comments came from big pharmaceutical manufacturers like Pfizer, Boehringer Ingelheim.

18th April 2017

Concept Paper for Combination Products-EMA
A concept paper on ‘developing a guideline on quality requirements of medicinal products containing a device component for delivery or use of the medical product’ is released by the European Medicines Agency (EMA). The concept paper advocates the need for development of a guideline on dossier requirements for medical devices that are supplied along with medicinal products....

18th April 2017

Mutual Recognition Agreement for GMP Inspections between US and EU is finalized: Applicable to both the regions
A big step towards saving time and money came into being when following a three-year-process, the United States (represented by the US FDA) and the European Union (represented by the European Commission) finally announced their agreement to mutually recognize.

18th April 2017

New Strategic Plan for 2017-2019: Issued by PIC/S
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) released the new road map for the next two years. PIC/S declared that training would be imparted to its most important field of activity i.e. revised Annex 1 on Sterile Manufacturing of the PIC/S GMP Guide corresponding to the July 2016 launch of the PIC/S Inspectorates’ Academy (PIA).

18th April 2017

Consideration should be given to API mixtures and CEP Procedure
Certificate of Suitability (CEP) granted by the Certification Secretariat of the European Directorate for the Quality of Medicines (EDQM) confirms that pharmaceutical substances or active pharmaceutical ingredients (API) are produced according to.

13th February 2017

Wockhardt Limited at Gujarat received a warning letter from US FDA along with an Import alert.
US FDA issued a warning letter, dated 23 December 2016, to Indian manufacturing facility Wockhardt Limited, located at Ankleshwar, Gujarat. FDA had inspected this facility in December 2015 and issued a warning letter. The firm provided its response in January 2016, and also stated that.

13th February 2017

Interquim, S.A., at Barcelona received US FDA warning letter.
The U.S. FDA inspected drug manufacturing facility, Interquim, S.A., at Barcelona, in May 2016, and issued a warning letter, dated 22 November 2016. The summarized significant deviations from CGMP for API’s are as following.

13th February 2017

FDA is announcing the availability of a Guidance on “Contract Manufacturing Arrangements for Drugs: Quality Agreements”
US Food and Drug Administration (FDA) finalized a Guidance for industry entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements’ in November 2016. This guidance is limited to commercial manufacturing activities and describes the definition.

13th February 2017

Changes being considered to Drugs and Cosmetic rules & GMP rules by CDSCO
PE 009-13 is the PIC/S GMP Guidance which have been revised and got into force from 1st January. The revision has been successfully completed on the Harmonisation of GM(D)P by the PIC/S Sub-Committee. The Chapters of guidance which have been undergone revision are Chapter.

13th February 2017

A Draft Guidance for "Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments" was released from PIC/S.
A Draft Guidance for "Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments" was released from PIC/S. "Data Governance" means the sum of all measures taken to assure data integrity. In Chapter 5 of draft guidance.

17th November 2016

Warning letter given to Brazilian Over-The-Counter Drug Manufacturer
FDA has given a warning letter to Brazil’s Mappel Industria de Embalagens on account of GMP violations related to over-the-counter drugs. The inspection was held at Sao Paulo-based manufacturing facility from 11 April to 15 April.

17th November 2016

New agreement between EU and Japan for sharing more information on GMP inspections
The European Directorate for the Quality of Medicines and Healthcare (EDQM) has announced a new agreement with Japanese authorities to share more information on the outcome of good manufacturing practice (GMP) inspections of manufacturing sites of active pharmaceutical.

17th November 2016

Warning given to Japanese active pharmaceutical ingredient (API) maker Nippon Fine Chemical Co., Ltd for impeding an FDA inspection
The US Food and Drug Administration (FDA) has warned Japanese active pharmaceutical ingredient (API) maker Nippon Fine Chemical Co., Ltd for impeding an FDA investigator from conducting an inspection of the company's facility in Takasago City, Japan, last December.

17th November 2016

Changes being considered to Drugs and Cosmetic rules & GMP rules by CDSCO
India's central drug regulator is considering changes to the Drug and Cosmetics Rules like extending the validity of various licences and approvals in a move to improve ease of doing business for the industry. The government is planning .

17th November 2016

EMA GMP inspection successfully completed for XBiotech (XBIT)
The EMA’s Competent Authorities of France (The French Agency for the Safety of Health Products), conducted the inspection of XBiotech Inc.

17th November 2016

US FDA has issued warning letters to three European and one Chinese drugmaker
String of warning letters has been issued by US FDA at facilities run by firms in China, the UK, The Netherlands, Switzerland and China due to cGMP violations.

17th November 2016

Warning given to Teva’s Banned Hungary Manufacturing Facility by USFDA
The US Food and Drug Administration (FDA) has warned Teva’s Hungary-based manufacturing site, citing deficiencies in manufacturing operations and laboratory controls, as well as the company’s data integrity program.

17th November 2016

cGMP Plant established in IIIM Jammu
Current Good Manufacturing Practices (CGMP) Plant facility has been recently established in Jammu which would provide a high level world-class infrastructure for the manufacture of botanical.

17th November 2016

FDA to increase vigilance over the pharmaceutical countries within Nashik District
The Food and Drug Administration (FDA), Nashik has decided to keep strict vigilance on pharmaceutical companies across the district to ensure they follow all guidelines and not breach legal provisions of the Drugs and Cosmetics Act, 1940.

17th November 2016

Warning given by France's medicines regulatory authority of fake GMP certificates
According to France's medicines regulatory authority s, companies are selling active pharmaceutical ingredient (APIs) with forged documents.

17th November 2016

Ban imposed on medicines manufactured by Maryland-based contract manufacturing organization by EMA’s CHMP
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended to ban the medicines manufactured by Maryland-based contract manufacturing organization (CMO) Pharmaceutics International

08th October 2016

Sun Pharma working on making its plants cGMP compliant globally
Sun Pharmaceutical Industries is working on making its manufacturing facilities compliant with good manufacturing practices and has asked the US health regulator to re-inspect its Halol plant as Sun Pharma has already taken detailed remediation at the Halol facility post the September 2014 inspection.

08th October 2016

Sun Pharma working on making its plants cGMP compliant globally
Sun Pharmaceutical Industries is working on making its manufacturing facilities compliant with good manufacturing practices and has asked the US health regulator to re-inspect its Halol plant as Sun Pharma has already taken detailed remediation at the Halol facility post the September 2014 inspection.

08th October 2016

Successful inspection for Lannett’s three manufacturing facilities by USFDA
The U.S. Food and Drug Administration (FDA) recently completed a cGMP inspection of the Lannett’s manufacturing facility in Philadelphia, as well as inspections of two facilities located in Armenia (Darmantest Laboratory, the company's pharmacokinetic subsidiary and Firmplace, a stability laboratory with which the company has a strategic relationship).

08th October 2016

Ban imposed by USFDA on India’s Laxachem Organics due to GMP noncompliance
The USFDA has banned products of Laxachem Organics, a maker of active pharmaceutical ingredients, from US markets as part of the effort to arrest the Burkholderia cepacia or the B Cepacia infection- a complex group of bacteria resistant to antibiotics. Laxachem issue is the first time where the US regulator has hinted.

08th October 2016

No critical observation found as a result of UK health regulator’s GMP inspection at Wockhardt’s Aurangabad facility
The UK regulator had in October 2013 withdrawn the GMP certificate to the Chikalthana plant and had also initiated recall of five prescription medicines from there. In December 2015, Wockhardt received a good manufacturing practice (GMP) certificate from the UK health regulator for its Chikalthana plant after an inspection.

08th October 2016

Indian CDSCO plans recruitment of 500 GMP inspectors
According to pharmabiz.com, the Indian Central Drug Standards Control Organization (CDSCO) is planning to recruit 500 more drug inspectors by the end of 2017. Up to now 147 inspectors have already been trained to enhance inspections of manufacturing units in line with current Good Manufacturing Practices (cGMP).

23rd September 2016

Certification programme to tighten the quality standards in its domestic drug industry
CDSCO has taken initiative to upgrade the skills of employees working in pharmaceutical and biologic manufacturing in order to bring great improvement in the quality of pharmaceutical products. The deadline set by CDSCO for completion of certification programme by all personnel in companies is 1st Jan 2018.

23rd September 2016

Six observations issued by USFDA to Indoco’s Goa Plant on account of violation of good manufacturing norms
Goa’s Indoco Remedies plant was inspected by USFDA from August 31, 2016 to September 4, 2016. On account of inspection, USFDA has issued six observations due to violation of good manufacturing norms. The injectable abbreviated new drug application (ANDA) filings triggered this inspection.

23rd September 2016

New warning letter by FDA issued to Chinese API manufacturer Zhejiang Medicine Co. Ltd focus on data integrity
The focus of FDA's Warning Letter for the Chinese API manufacturer Zhejiang Medicine Co. Ltd. dated 4th August 2016 is on the lack of data integrity. A number of alarming findings were discovered in the course of the FDA inspection in June 2015 such as deletion of original data and unavailability of records of activities at the time when they were performed.

23rd September 2016

Regulators on strict scrutiny over drug manufacturing companies
Recently Britain’s regulatory body evoked its GMP certificate for Pfizer’s Chennai Plant over quality issues and put an alert on the products made there. Between 2011 and 2016, 27 drug manufacturing plants in India received warning letters from the US Food and Drug Administration (FDA)

12th August 2016

Warning letter issued to GlaxoSmithKline over contamination at a Penicillin Plant in UK
US FDA has issued a warning letter to GlaxoSmithKline over quality control problems observed at Penicillin manufacturing facility located in Worthing in the United Kingdom. GlaxoSmithKline is therefore recalling a “small”

12th August 2016

Warning letter issued to Chinese drug manufacturer Xiamen Origin Biotech over cGMP violations
The US Food and Drug Administration (FDA) has issued a warning letter to Chinese drug manufacturer Xiamen Origin Biotech over "significant deviations" in the company's manufacturing practices for active pharmaceutical ingredients (APIs).

12th August 2016

New draft guidance issued by FDA to help drug compounders address insanitary conditions at their facilities
The US Food and Drug Administration (FDA) has issued new draft guidance intended to help drug compounders address insanitary conditions at their facilities. According to FDA, it is critical that compounding facilities avoid.

12th August 2016

Import alert issued to Wockhardt by USFDA
The US Food and Drugs Administration (FDA) issued an import alert on Wockhardt’s Ankleshwar plant on account of GMP violations. The US FDA had carried out an inspection at the Ankleshwar plant in November last year and issued adverse observations known as Form 483 for violating good manufacturing practices.

12th August 2016

Pfizer under list of drugmakers for deviating from Good Manufacturing Practices
In the last week of June, a high profile team drawn from world's four leading regulators identified a number of deficiencies related with GMP violations at Pfizer’s Irungattukottai facility, near Chennai. The team included UK's Medicines and Healthcare products Regulatory Agency (MHRA), US FDA, Therapeutic Goods.

12th August 2016

GMP non-compliance observed by MHRA at two US sites for Pharmaceutics International Inc
The Medicines and Health Care products Regulatory Agency (MHRA) has observed critical deficiencies at US based contract manufacturing organization Pharmaceutics International, Inc. for two of its Maryland facilities

05th July 2016

GMP non-compliance observed by MHRA at two US sites for Pharmaceutics International Inc
The Medicines and Health Care products Regulatory Agency (MHRA) has observed critical deficiencies at US based contract manufacturing organization Pharmaceutics International, Inc. for two of its Maryland facilities

05th July 2016

Agreement signed between Export Inspection Council of India and the US health regulator to facilitate sharing of information relating to import alerts
Export Inspection Council of India (EIC) and the US health regulator have signed an agreement in order to facilitate the sharing of information with respect to import alerts.

05th July 2016

Warning Letter issued to BBT Biotech, Germany by USFDA on account of Data Integrity Issues
The USFDA has issued a warning letter to BBT Biotech; Germany on account of GMP violations. The company needs to respond to the letter with measures taken to remedify the deviations / violations within 15 working days of receipt of the letter.

05th July 2016

Non-compliance report with respect to GDP issued in EudraGMDP by Czech Republic
The competent authority of the Czech Republic issued three GDP non-compliance reports to three companies which were entered into the community database for GMP and GDP compliance. While GMP Non-Compliance Reports are entered frequently, reports about GDP compliance issues are not published very often.

05th July 2016

Warning letter issued to S.R. Burzynski Manufacturing Facility, Texas on account of cGMP violations
The U.S. Food and Drug Administration (FDA) inspected the clinical supply manufacturing facility, S.R. Burzynski Manufacturing Facility at 12707 Trinity St., Stafford, Texas and issued warning letter which summarizes significant.

28th June 2016

ISO Warning letter issued to Mumbai based Megafine Pharma by USFDA
Mumbai based Megafine Pharma has received a warning letter from USFDA on account of violations of Good Manufacturing Practices. Summarizing the violations from cGMP (current good manufacturing practice) norms at the Nasik facility

28th June 2016

Imports banned from Teva’s Hungary Plant by FDA except for two drugs in shortage
The US FDA has announced an import alert prohibiting drugs made at the Godollo, Hungary-based manufacturing site from entering the US.

28th June 2016

Domestic Pharma Manufacturing Site Inspections significantly decline for CFDA
According to a recently released annual report from the Center for Food and Drug Inspection of CFDA (China’s Food and Drug Administration), CFDA inspected.

28th June 2016

Roadmap designed to chart the path to large-scale manufacturing of cell-based therapeutics
A national roadmap has been designed by an industry driven consortium to chart the path to large-scale manufacturing of cell-based therapeutics for use.

28th June 2016

The API manufacturers in India remain in the limelight of European GMP Inspectors
According to The EudraGMDP database, Indian API manufacturers are having more frequent non-compliance reports as observed in three of the reports

28th June 2016

WHO released final guidance document on Good Data and Record Management Practices
WHO has released the final version of the Good Data and Record Management Practices. In the guidance document "good documentation practices" has now been

06th June 2016

ISO 22716 Cosmetics GMP awarded to Bollore Logistics
The ISO 22716 cosmetic GMP introduces a management systems’ approach to documenting and regulating the production, control, storage and shipment of cosmetics products.

06th June 2016

Draft Supplementary guidelines on GMP HVAC systems released by WHO
The WHO has released supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms. During the consultation on data management, bioequivalence.

06th June 2016

Draftguidance released by FDA concerning additive manufacturing technologies for 3D printed medical devices
The U.S. Food and Drug Administration (FDA) has issued draft guidance for additive manufactured medical devices.

06th June 2016

Pharma manufacturers to be trained in good manufacturing practices after USFDA concerns by CDSCO
Currently there are no common regulations in India for the pharma manufacturing practices as a result of which the USFDA has constantly issued warning.

06th June 2016

New draft guideline on the sterilization with regards to the manufacturing of Medicinal Products, APIs, Excipients and Primary Containers released by EMA
EMA has released a new draft guideline entitled "Guideline on the sterilization of the medicinal product, active substance, excipient and primary container

06th June 2016

New policy with respect to grouping of supplements for chemistry, manufacturing and controls (CMC) changes released by FDA
The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) has released a new document with respect to grouping of supplements and their submission concurrently for the same chemistry.

06th June 2016

Critical cGMP Global Operations Center for Genzyme Corporation, a Sanofi Company has been acquired by Capri EGM
Capri EGM is an investment company specializing in corporate sale leaseback and build-to-suit financing, and the acquisition of institutional quality single-tenant office.

06th May 2016

Warning given to Sri Krishna Pharmaceuticals by FDA on serious quality control violations
Sri Krishna Pharmaceuticals Limited (SKPL) is the pioneer in the manufacture of ACETAMINOPHEN (PARACETAMOL) for the domestic market and is today.

06th May 2016

Steps Taken for setting up of cGMP facility for yellow fever drugs by the government of India
To ensure that Indian vaccine manufacturers have global quality standards, the government is exploring the feasibility of establishing WHO.

06th May 2016

Two Indian APIs removed from Pre-qualification list by WHO for GMP non-compliance
Pyrazinamide and Sulfadoxine, two APIs of the Indian pharma manufacturer Anuh Pharma Ltd has been removed from the WHO list of pre-qualified APIs by the World Health Organization.The step has been taken as a result of an inspection.

06th May 2016

Guidance on process validation with respect to good manufacturing practice finalized by EMA
Process validation is defined in International Conference for Harmonization's (ICH) Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients as, "The documented evidence that the process, operated within establish parameters.

06th May 2016

Good Manufacturing Practices to be adopted by Vaidyakhana Bikas Samiti, Nepal based herbal medicine producer
After receiving the approval to build a GMP certified production house under WHO guidelines, which include upgrading its production equipment, lab and building, Venerable herbal medicine producer Singha Durbar Vaidyakhana Bikas Samiti.

25th April 2016

FDA offers new draft guidance on Data Integrity in cGMP Drug Manufacturing
US FDA has released new draft guidance on data integrity in cGMPmanufacturing due to recent concerns over data.

25th April 2016

Non-compliant Chinese manufacturers continue to be under FDA scanner
US FDA has issued import alert to three more Chinese Pharmaceutical companies for failing to meet the good manufacturing practice (GMP) standards of FDA and for refusing an FDA inspection. According to FDA.

25th April 2016

Shut down of 16 Herbal Medicine Facilities at Nigeria by NAFDAC (The National Agency for Food and Drug Administration and Control)
The National Agency for Food and Drug Administration and Control (NAFDAC) had shut 16 herbal medicine facilities and seized products over illegal operations in Onitsha, Anambra. The raid was done for the illegal.

25th April 2016

Non-compliance report issued to Marksans Pharma Limited on account of GMP violations by MHRA
The British authority MHRA (Medicines & Healthcare products Regulatory Agency)had published a Non Compliance Report against the Indian company Marksans Pharma Limited on account of data integrity issues.

25th April 2016

GMP certificate given to Shilpa Medicare for two of its API sites from Japan Regulator (PMDA-Pharmaceuticals and Medical Devices Agency)
Shilpa Medicare Ltd is an API manufacturer based in Raichur, Karnataka, India. Currently the company is one of the leaders in the Oncology market and offer a complete range of products in this segment spanning across APIs.

11th March 2016

Training Modules on "ICH Q3D - Elemental Impurities" published by ICH
The ICH has published the long-announced training modules on the ICH Q3D Guideline "Elemental Impurities".

11th March 2016

Warning letter issued to a Manufacturer of Medicinal Products in Hong Kong by FDA
The FDA issued a warning letter to a manufacturer of medicinal products in Hong Kong on 15 December 2015. The FDA investigator identified.

11th March 2016

India and EU working together to sort out regulatory issues with respect to GMP
India and EU are engaged together to sort out regulatory issues between the two countries and expand and strengthen technical co-operation on good manufacturing practices on account of 28-nation block's.

11th March 2016

Major GMP violations at API manufacturers in India and China
Two Non-Compliance reports were issued at the end of last year at API production sites in China and India. GMP inspectors from the French competent authority found 2 critical.

11th March 2016

Falsification and GMP Non-compliance again observed with Chinese Heparin Manufacturer
In 2008 adulterated Heparin from China caused the death of 81 people and 785 reports of serious injuries.A comprehensive investigation of the US congress identified weaknesses in the GMP Inspection

08th February 2016

Yearly List of New and revised draft guidances published by The U.S. Food and Drug Administration (FDA)
The yearly list of new and revised draft guidances had been published by The U.S. Food and Drug Administration (FDA). A total of 102 planned guidance documents have been.

08th February 2016

Revised guideline named “ WHO GMP for Biological Products”listed by WHO
The WHO has listed a revised guideline WHO GMP for Biological Products which is a 38-pages guideline and applies to the manufacture, control and testing of biological products for human use, from starting materials and preparations.

08th February 2016

Dr. Reddy’s Laboratories to resolve issues raised by USFDA regarding cGMP norm violations
Dr. Reddy’s Laboratories had received a warning letter on November 5, 2015 from the USFDA regarding deviations from current good manufacturing practices (CGMP) at its active pharmaceutical ingredient (API) facilities at Srikakulam.

08th February 2016

13334 Indian Products and 15087 Chinese products rejected by USFDA in past 6 years on account of GMP violations
According to the FDA data, 13,334 products made in India and imports of 15,087 Chinese products were rejected by the US Food and Drug Administration.

08th February 2016

COMMISSION DELEGATED REGULATION (EU) 2016/161 of 2 October 2015 published by the European Union on 9th February 2016
On 9th February 2016 the European Union has published the "COMMISSION DELEGATED REGULATION (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament.

15th January 2016

Yearly List of New and revised draft guidances published by The U.S. Food and Drug Administration (FDA)
The yearly list of new and revised draft guidances had been published by The U.S. Food and Drug Administration (FDA). A total of 102 planned guidance documents have been

15th January 2016

Revised guideline named “ WHO GMP for Biological Products”listed by WHO
The WHO has listed a revised guideline WHO GMP for Biological Products which is a 38-pages guideline and applies to the manufacture, control and testing of biological products for human use, from starting materials and preparations.

15th January 2016

Dr. Reddy’s Laboratories to resolve issues raised by USFDA regarding cGMP norm violations
Dr. Reddy’s Laboratories had received a warning letter on November 5, 2015 from the USFDA regarding deviations from current good manufacturing practices (CGMP) at its active pharmaceutical ingredient (API) facilities at Srikakulam.

15th January 2016

13334 Indian Products and 15087 Chinese products rejected by USFDA in past 6 years on account of GMP violations
According to the FDA data, 13,334 products made in India and imports of 15,087 Chinese products were rejected by the US Food and Drug Administration.

15th January 2016

COMMISSION DELEGATED REGULATION (EU) 2016/161 of 2 October 2015 published by the European Union on 9th February 2016
On 9th February 2016 the European Union has published the "COMMISSION DELEGATED REGULATION (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and.

10th December 2015

Wockhardt's Chikalthana Plant Clears GMP Certificate from UK Health Regulator MHRA and Climbs in Share Price

Wockhardt’s Chikalthana plant at Aurangabad in Maharashtra has received a good manufacturing practice (GMP) certificate from the UK health regulator (MHRA) as post- inspection result..

10th December 2015

Anuh Pharma Receives GMP Certificate for Anti-Bacterial Drug; Blows Up 2.4%

Anuh Pharma is one of the leading manufacturers of Active Pharmaceutical Ingredients (API's). Registered in 1960, the company has grown several folds and ..

10th December 2015

US FDA Wants Third-Party Audit for GMP and Compliance of Dr Reddy's Units

The US Food and Drug Administration (FDA) inspected three main Indian facilities of Dr.Reddy’s Laboratory and issued warning letters for facility.

10th December 2015

Exporters Stipulate to Enhance Validity of WHO GMP Certificate from 2 To 3 Years

The pharmaceutical exporters have demanded to enhance the validity period of World Health Organization - Good Manufacturing Practices (WHO GMP) ..

10th December 2015

GMP Challenges for Advanced Therapy Medicinal Products

Finalizing GMP requirements and quality standards for the development, manufacture, and clinical testing of Advanced Therapy Medicinal Products (ATMPs) in the EU is proving to be a complex task.

10th December 2015

USFDA Issues Warning Letter for Three Indian Facilities of Dr. Reddy’s Laboratory

USFDA has made charges against DRL for significant deviations from current Good Manufacturing Practices for manufacture of APIs at two facilities and violations of CGMP.

10th December 2015

4Life Starts New Manufacturing Facility in Vineyard, Utah

4Life General Managers from around the world gathered for a ribbon-cutting at the new 4Life manufacturing facility in Vineyard, Utah. The facility will

26th November 2015

The European Commission publishes the final version of the revised EU-GMP Guideline Annex 16 Certification by a Qualified Person and Batch Release

The European Commission has published the final version of the revised EU-GMP Guideline. The guideline specified in Annex 16, under the title..

26th November 2015

FDA Bans Imports from Major Indian API Manufacturer

Indian active pharmaceutical ingredient (API) manufacturer Megafine Pharma's Nashik site in Maharashtra, India, is now added to the list of foreign manufacturing sites.

26th November 2015

Novartis gets USFDA warning letter for two plants in India

Indian active pharmaceutical ingredient (API) manufacturer Megafine Pharma's Nashik site in Maharashtra, India, is now added to the list of foreign manufacturing sites ..

26th November 2015

UK™s MHRA Calls out GSK China Plant over GMP Non-Compliance

The UK™s Medicines and Healthcare products Regulatory Agency (MHRA) on Friday released an inspection report that found a GlaxoSmithKline (GSK)

26th November 2015

DCC invites suggestions for amendment of Schedule M of Drug & Cosmetic (D&C) Rules

The Drug Consultative Committee (DCC) has proposed the amendment of Schedule M of Drugs & Cosmetics Rules (D&C Rules), 1945 to harmonize the provision with WHO.

26th November 2015

Cartiva announces GMP Certification by Brazil’s regulatory agency ANVISA

Cartiva, Inc. announced that it has received GMP (Good Manufacturing Practices) certification from Brazil's National Health Surveillance Agency (known as ANVISA).

26th November 2015

USFDA warns Unimark over violating GMP norms

The US Food and Drug Administration (USFDA) has issued a warning letter to Unimark Remedies for violating current good manufacturing practice norms at its plant near Ahmedabad in Gujarat.

26th November 2015

China Food and Drug Administration (CFDA) issues four guidelines for Medical Device Good Manufacturing Practice on-site inspection

China Food and drug Administration has issued various important guidelines to promote the implementation of the Good Manufacturing Practice for Medical Devices

26th November 2015

Novartis gets FDA approval for skin cancer drug combination

Novartis AG announced on Friday that the US Food and Drug Administration (FDA) has provided a regular approval for its new drug combination for treatment.

07th October 2015

PAN Drugs receives warning letter from USFDA

USFDA has recently issued a warning letter to PAN drugs Vadodara based plant due to significant deviations from good manufacturing practices.

07th October 2015

MHRA issues recall notice of Lacri-Lube eye ointment

The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a recall notice to Allergen Limited. The recall notice relates to 5g and 3.5g pack sizes of

07th October 2015

Another Import Ban for Polydrug Laboratories

USFDA (Food and Drug Administration) issues import ban for products manufactured by Polydrug Laboratories. It was issued on Sept. 11, 2015 for

07th October 2015

Health Canada lifts its ban from two Apotex facilities in India

Health Canada has lifted its ban from Apotex two Indian facilities. Canada�s drug regulator reinspected the two plants in June and determined

07th October 2015

33 drugs were found to be of not of standard quality during Surprise inspection

Recently Karnataka drug control department had conducted surprise inspections to pick up drug samples at random. The drug test labs have issued their result.

07th October 2015

Vivimed Labs successfully completes USFDA inspection of its manufacturing facility

Vivimed Labs has recently successfully completed inspection of its API manufacturing facility in Spain. After the completion of inspection Vivimed said �the USFDA inspectors concluded

14th September 2015

Pharmaceuticals Export Promotion Council of India (Pharmexcil) updates its database

The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has recently updated and added regulatory data for Ayush products of five more countries to its

14th September 2015

USFDA issues warning letter to Mylan for lapses in three units at Karnataka

USFDA has issued a warning letter to Mylan Laboratories for its three plants in Karnataka. The US Food & Drug Administration (USFDA) issued the letter due.

14th September 2015

Health Ministry of India soon to amend Schedule K for providing exemption from GMP compliance for export

The Union health ministry will soon amend Schedule K of the Drugs and Cosmetics Rules, 1945. The amendment will make a provision under the Drugs and Cosmetics

Anvisa approves Caplin point Chennai located sterile injectable site

Anvisa, Brazilian regulatory authority has recently approved Caplin point sterile injectable manufacturing site at Chennai. After approval from Brazil's National Health Surveillance

US Food and Drug Administration issues warning letter to Cepheid's Swedish site

The US Food and Drug Administration has issued a warning letter to Cepheid's European manufacturing and R&D site in Solna, Sweden

Dr. Reddy's voluntarily recalls Rivastigmine Tartrate Capsules from US market

Dr. Reddy™s has recently voluntary recalled Rivastigmine Tartrate Capsules of 1.5 mg strength from the USA market, following

French National Agency for Medicines and Health Products Safety (ANSM) releases TxCell manufacturing facility inspection report

The French National Agency for Medicines and Health Products Safety (ANSM) has released the Tx cell manufacturing inspection report.

3rd August 2015

MHRA develops a new blog on GMP Data integrity

MHRA has recently developed a new blog on GMP Data integrity in addition to the existing data integrity guideline by the MHRA.

EMA issues draft guideline on manufacture of the finished dosage form

EMA has recently issued draft guideline on manufacture of the finished dosage form. This guideline replaces

FDA issues Guidance for Industry on "Allowable Excess Volume and Labelled Vial Fill Size in Injectable Drug and Biological Products"

USFDA recently issues its final guidance for industry on Allowable Excess Volume and labelled Vial Fill Size in Injectable Drug and Biological Products

USFDA orders for recalls of drug products from three pharmaceutical firms

US Food and Drug Administration (FDA) has ordered the recall of all drug products from Allied Pharmaceutical Laboratories Inc.

"USFDA issues Form 483 to Lupin’s Goa Plant"

The US Food and Drug Administration (USFDA) has issued Form 483 to Lupin & trades Goa plant. The Goa plant supplies drugs (oral solids and formulation) to markets

US FDA issues warning letter to Mahendra Chemicals, Gujarat

U.S. Food and Drug Administration (FDA) has issued warning letter to Mahendra Chemicals manufacturing facility, Gujarat, India.

EMA announces conduction of review of Medtronic’s product, InductOs

The European Medicines Agency (EMA) has announced it is conducting a review of Medtronic's implantable bone-development product, InductOs.

Caplin Point gets European Union (EU GMP) approval for its Chennai located Sterile Injectable Site

Caplin Point has received European Union (EU GMP) approval for its small volume sterile injectable liquids facility at Chennai. Commenting on

10th July 2015

European Medicinal Agency soon to issue New GMP annex for importers of medicinal products

The European Medicinal Agency (EMA) will soon release a new GMP annex to EU GMP Guidelines. EMA has released its concept paper on new guidance for importers of medicinal products

USFDA issues CMC (Chemistry, Manufacturing and Control) reportable changes draft guidance

The US FDA (Food and Drug Administration) has issued draft guidance on the established conditions: Reportable Chemistry,

Pharmacopeial Forum 41(1) publishes a new article on pharmaceutical packaging

Pharmacopeial Forum 41(1) publishes a new article “stimulus to the revision process" on pharmaceutical packaging. The article will be published as General Chapter

Wockhardt again recalls captopril tablets from market along with clarithromycin tablets

Wochardt has recently recalled 166 bottles of captopril tablets of 50 mg strength along with 50 bottles of clarithromycin tablets of 500

Mylan expanding its nationwide recall in US to hospital/user level

Mylan has announced that its U.S.-based Mylan Institutional business is expanding its voluntary nationwide recall to the hospital/user level

USFDA issues warning letter to Insulet Corp

USFDA (Food and Drug Administration) has issued Insulet Corp Form 483 over some insulin pumps. Insulet official said "The letter relates to

Polydrug API Plant found to have 17 breaches of cGMP requirements at its Maharashtra plant

The agency for medicinal products and medical devices of the Republic of Solvenia (Jazmp) conducted inspection of Polydrug API India based Plant

AmpliPhi Biosciences announces grant of cGMP Certification for its Bacteriophage Facility

AmpliPhi Biosciences on 3rd May, 2015 has announced that it has received good manufacturing practices certification for its bacteriophage facility in

1st June 2015

USFDA issues Form 483 to Impax Laboratories Hayward, California manufacturing facility

USFDA has issued Impax laboratories form 483 Hayward facility. Impax on 11th May, 2015 announced that FDA performed a three week inspection

Nectar Lifesciences Limited (NecLife) receives ANVISA approval for its Cephalosporin API's manufacturing facility

Nectar Lifesciences Limited (NecLife) has received ANVISA cGMP ("Current Good Manufacturing Practices") approval for its Cephalosporin API's manufacturing facility. The National Health Surveillance Agency

Therlase manufactures high purity anti cancer drug meeting GMP standards

Theralase technologies inc. has successfully manufactured GMP grade lead, light activated, anti cancer drug, TLD-1433, specifically developed for the treatment of cancer. This latest high purity batch will be used

Wockhardt's voluntarily recalls captopril tablet from market

Wockhardt has initiated recall of 93,393 bottles of blood pressure drug captopril tablets in the US market due to failing to meet specifications. It is a Class II recall. A class II

USFDA issues warning letter to two sterile compounders

US FDA has recently issued warning letter to Florida based absolute pharmacy and Van Healthcare Services. Florida based Absolute Pharmacy

6th May 2015

Health Canada recently launches GMP inspection database

Health Canada has recently launched a GMP inspection database. This database contains 3,821 inspections (per March 2015) which

Health Ministry planning over India being member country to Pharmaceutical Inspection Convention (PIC) PIC/SÂ

Union Health Ministry is seriously planning over making India a member country to Pharmaceutical Inspection Co-operation Scheme (PIC/S) initiative

Eurpoean Medicine Agency (EMA) publishes guideline "Elemental impurities in marketed products. Recommendations for implementation"

On 27 March 2015, Eurpoean Medicine Agency (EMA) has published guideline "Elemental impurities in marketed products. Recommendations for implementation"

Wockhardt voluntarily recalls 12 drugs manufactured in its two Indian facilities, Chikalthana and Waluj from US market

Wockhardt on 29 April, 2015 has decided to voluntarily recall its products manufactured in its two Indian facilities, Chikalthana and Waluj facilities from US market

USFDA issues warning letter to Natus Medical Incorporated

USFDA has issued warning letter to Seattle located Natus Medical Incorporated firm on 10th April, 2015. Natus Medical Incorporated manufactures

FDA warns for use and ceases distribution of supplements containing DMBA (1, 3 -Dimethylbutylamine)

FDA has recently demanded that 14 companies in the natural products industry cease distribution of supplements that contain a substance known a

European Union (EU) publishes its final revised EurdraLex Volume 4, Annex 15 guideline

European Union has published its revised EurdraLex Volume 4, Annex 15: Qualification and Validation guidelines. This document is a GMP

MHRA publishes revised Pre-Inspection report and Interim Compliance report guidance Â

MHRA has published its revised guidance for Pre-Inspection report and Interim Compliance report in March 2015. In revised documents a section on

USFDA issues import alert to IPCA labs’ two manufacturing sites

IPCA Labs has received US Food and Drug Administration (FDA) import alert for two of its Active Pharmaceutical Ingredient (API) manufacturing units

USFDA has issued warning letter to Hospira’s Italian facility

Hospira has received warning letter from USFDA for its Italy based plant on 31st March, 2015. Hospira makes biosimilars and a generic

USFDA issues Form 483 to Galena Biopharma (GALE)

USFDA has issued warning letter to galena Biopharma on April 6, 2015. During inspection to Galena Pharma Portland, Oregon facility the U.S.

FDA warns for the use of product from Prescription Center Pharmacy in Fayetteville, North Carolina

FDA has warned health care professionals and patients not to use products from the Prescription Center Pharmacy in Fayetteville, N.C. due

Eurogetac has successfully manufactured 150 grams of GMP grade plasmid DNA

Eurogentec SA, a contract manufacturing organization has successfully manufactured 150 grams of GMP grade plasmid DNA.

30th March 2015

FDA has published final draft guidance for industry on mixing, diluting, or repackaging biological products outside the scope of an approved Biologics License Application (BLA)

FDA in February has published new draft guidance for industry on Mixing, Diluting, or Repackaging Biological Products outside the scope of an approved Biologics License Application,

USFDA issues its final guidance on medical devices reprocessing: "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling"

USFDA has finally issued its final guidance on reprocessing of medical devices on March 12, 2015. The draft guidance was released in 2011

India Health Ministry planning for amending Schedule MIII

To improve the quality of manufactured medical devices Health Ministry of India has proposed amendment to Schedule MIII

National Science Foundation (NSF) has published 1st American Standard on GMP for pharmaceutical excipients

The National Science Foundation (NSF), a United States government agency has published first American standard on GMP for

PIC/S (Pharmaceutical Inspection Co-operation Scheme) publishes its two revised GMP guidance documents

On Jan 2014, PIC/S (Pharmaceutical Inspection Co-operation Scheme) published two revised GMP annex guidance document namely

Indian Pharma Companies needs external support to resolve Data Integrity Issues: USFDA

During the year 2014, USFDA issued warning letters to Indian pharmaceutical companies on data integrity issues.

European Medicinal Agency publishes its Works Plan for GMP/GDP Inspectors Working Group for 2015

European Medicinal Agency published its Works Plan for GMP/GDP Inspectors Working Group for 2015.

Sun Pharma voluntarily recalls Ketoroloc Tromethamine eye drop in US for failing to meet specifications

Sun Pharma is voluntarily recalling over 5000 bottles of Ketorolac Tromethamine ophthalmic solution in the US market for failing

Hospira voluntarily recalled sodium chloride and magnesium sulfate injections due to contamination and labeling error respectively

Heritage and Sagent Pharmaceuticals recalled their products due to sterility concerns

Heritage and Sagent Pharmaceuticals recalled their products due to sterility concerns

Sagent and Heritage pharmaceuticals are voluntarily recalling their products following FDA observations of practices

26th February 2015

FDA released draft guidance for cGMP requirements for Combination Products

FDA Released Draft Guidance for cGMP requirements for Combination Products codified as 21 CFR part 4. These draft guidance, when finalized,

European Medicinal Agency (EMA) released concept paper on revision of GMP guidelines for sterile product manufacturers

EMA prepared a draft concept paper for revision of Annex 1 which gives GMP guideline for the manufacturers of sterile

A new USP Chapter on “Visual Inspection of Injections published for comments

A new chapter no. 1790 which is regarding the 100% visual control of injectables is issued as a first draft

MHRA new guidance for industry on GMP data integrity definitions

MHRA announced its guidance for industry on GMP data integrity definitions on January, 2015. Data integrity requirements

European Union (EU) issues its revised GMP guidance™s for Production and "Premises and Equipment"

Production and "Premises and Equipment" are chapter 3 and Chapter 5 of good manufacturing practice (GMP) guidance's

Global Recall of multiple Lots of Ketorolac Tromethamine injection due to potential particulate in glass vials

Global Recall of multiple Lots of Ketorolac Tromethamine injection distributed from February 2013 to December 2014 in the United States

FDA issues warning Letter to Verichem Laboratories

FDA has issued warning letter to Verichem Laboratories for manufacturing adulterated medical devices on February 4

Health Canada issues notice regarding regulation for commercially reprocessed single-use medical devices

Health Canada has issued notice for the companies that reprocess and distribute medical devices originally authorized

Iran attempting to adopt GMP guidelines for radiopharmaceuticals

Iran is currently attempting to acquire the good manufacturing practice (GMP) standards for radiopharmaceuticals.

Cynata will soon move to manufacture world first GMP-grade mesenchymal stem cells (MSCs)

Cynata Therapeutics (formally EcoQuest) is an Australian stem cell and regenerative medicine company that is developing

PLIVA Successfully completes FDA Inspection

PLIVA has successfully completed site inspection done by FDA on February, 2015. PLIVA’s Production process is regularly

VEXIM successfully completes GMP Inspection by Brazil's National Health Surveillance Agency (ANVISA)

Vexim is a medical device company created in February 2006. Recently Brazil's National Health Surveillance Agency

30th January 2015

Planning of GMP Inspections by FDA’s New Quality Metrics Programme

A comprehensive new organization has been initiated by the US Food and Drug Administration(USFDA) for its inspection activities.

GMP Approved Facility for Tianyin Pharmaceutical granted by China

China Food and Drug Administration (CFDA) has provided Good Manufacturing Practice (GMP) certificate to

USFDA Poses Import Alert on Ratlam Plant of Ipca Labs for Violations of Production Practices

Ipca Laboratories have announced on Friday that it had received an import ban for its active pharmaceutical ingredients

Suspension called for Generic Forms of Four Common Psychiatric Drugs by the European Medicines Agency

After observations were made about the use corrupt practices in the regulatory approval processes for the drugssuspension of

Gabapentin Capsules recalled by Aurobindo and Actavis

Following complaints of empty capsules in the US market, drug firm Aurobindo Pharma is recalling 24,816 bottles of Gabapentin devices

Action Plan Prepared by Apotex

Apotex Pharmachem is the largest manufacturer, researcher and developer of active pharmaceutical ingredients in Canada

15th January 2015

Launch Of Project to take care of quality control lapses at drug manufacturing sites by US FDA

US FDA took an initiative for reducing quality control issues at pharmaceutical manufacturing sites. At a news conference Dr. Janet Woodcock

Withdrawal of GMP certification from Indian manufacturer by Italian Medicines Agency

Italian Medicines Agency has issued a warning letter to the Hyderabad based Sri Krishna Pharmaceuticals due to GMP deviations

Detention of Drugs from Sri Krishna Pharma by Health Canada

Health Canada requested the Canadian importers to detain health products which use raw materials from the API manufacturer, Sri Krishna

Restrictions on Wockhardt Plant eased by UK regulator

The UK MHRA has carried out an audit of the Wockhardt's drug unit at Chikalthana, near Aurangabad in order to understand

Warning given to Chinese active pharmaceutical ingredients (API) manufacturer by USFDA-Indian Drug Manufacturers may be impacted

Chinese manufacturer Novacyl Wuxi Pharmaceutical has been given warning over basic manufacturing problems at its facility

New Medical Device GMP and GSP rules introduced by China

China's Food and Drug Administration ("CFDA") revised the existing provisional Good Manufacturing Practices for medical devices

USFDA import alert lifted from Costa Rica facility of Hospira

Hospira's Costa Rica facility received a warning letter from the agency in August 2012 as the devices manufactured at this site did not comply

For further enquiries, write to or call us on:
info@igmpiindia.org/ +91 8587838177, +91 8130924488, 0120-2427175, 0120-4375280

Pharmaceuticals | Food | Clinical Research | Healthcare | Medical Coding | Medical Device | Nanotechnology | IPR

Placement testimonials: Our alumni are working with Fortune 500 and global Pharmaceutical, Food and healthcare giants like