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GLOBALG.M.P.™ Newsletter


  • May 26, 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. ....
  • 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.

    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.

    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.

    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,

    April 18, 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....

    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

    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).

    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 .

    February 13, 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

    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,

    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

    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 .

    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,

    November 17, 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.

    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

    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.

    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 .

    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.

    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.

    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.

    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

    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.

    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.

    Lupin’s Goa manufacturing facility cleared by USFDA of violations of cGMP
    The US Food and Drug Administration (US FDA) has cleared Lupin Ltd’s Goa manufacturing plant of violations of good manufacturing practices (cGMP) observed during an inspection in March 2016.

    October 08, 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

    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.

    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).

    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 .

    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.

    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).

    September 23, 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.

    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.

    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.

    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.

    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)

    August 12, 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”

    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).

    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

    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.

    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

    Form 483 issued to Alexion’s Rhode Island Site by USFDA
    The US Food and Drug Administration (FDA) recently completed a routine current Good Manufacturing Practice (GMP) inspection of Alexion’s Smithfield, Rhode Island manufacturing facility and issued a Form 483 with three observations.
    July 5, 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

    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.

    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.

    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.

    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.
    June 28, 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

    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.

    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

    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

    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

    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
    June 06, 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.

    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

    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

    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

    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

    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

    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
    May 06, 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

    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

    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

    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,

    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..

    April 25, 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

    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

    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

    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.

    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,

    March 11, 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". The background for the development of

    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

    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

    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

    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

    February 8, 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

    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,

    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

    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

    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
    January 15, 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

    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,

    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

    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

    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
    December 10, 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..

    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 ..

    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.

    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) ..

    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.

    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

    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
    November 26, 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..

    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

    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 ..

    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)

    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

    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).

    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

    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

    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
    October 7, 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.

    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

    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

    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

    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.

    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


    September 14, 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

    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

    WHO issues Notice of Concern to Svizera Labs PVt. Limited facility in India

    WHO has recently issued a Notice of Concern (NOC) to Svizera labs Private Limited Indian facility. Svizera labs Private limited is a subsidiary of Maneesh

    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.


    August 3, 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


    July 10, 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


    June 1, 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


    May 6, 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/S

    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


    Apr 13, 2015

    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 

    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.


    Mar 30, 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


    Feb 26, 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


    Jan 30, 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


    Jan 15, 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


    Dec 31, 2014

    Nine Observations given to Dr Reddy's Laboratory at Srikakulam Plant by USFDA

    US FDA recently visited Dr Reddy's Laboratories manufacturing facility at Srikakulam district which is the bulk manufacturer of active pharmaceutical ingredients and bulk drugs

    Renewal of Food, beverage, drug, and medical device facilities with US FDA until December 31, 2014

    The facilities which produce FDA regulated drugs require to register with US FDA and renew their registrations according to defined time frame

    Health Canada's powers over medical device market increased due to new legislation

    A new legislation has been introduced by the Canadian government to protect consumers from unsafe medications and medical devices by reducing adverse events

    GMP Certification awarded to China Biologic Products, Inc for its New Coagulation Factor Facility

    GMP certification has been awarded to the majority owned subsidiary of China Biologic Products,

    Issuance of Form 483 by US FDA to IPCA Laboratories not the first time

    Recently on 19 December 2014, The Silvasa facility of IPCA Laboratories received Form 483 having 5 observations by US FDA However according to the documents

    Ban on the import of drugs manufactured at Dr Reddy's Labs (DRL) and IPCA Labs to Canadian Market

    Health Canada has decided to stop importing and distribution of products manufactured by Dr Reddy's Labs (DRL) and IPCA Labs at the Srikakulam and Pithampur facilities

    Clarification on Health Canada's issue by Dr Reddy's Laboratories

    Dr Reddy's has clarified that the company has voluntarily detained all APIs and formulations based on APIs at the Srikakulam district of Andhra Pradesh intended

    Indian Pharma Focusing on New Geographies

    Indian Pharma companies are focusing on gaining market access in new geographies that include countries such as Russia


    Dec 23, 2014

    Indian drug manufacturers may be benefitted due to vigilance by US FDA on Chinese Drug Companies

    US FDA has decided to increase the staff responsible for inspection in China. They have decided to increase the number of staff from 8 to 26 and number of drug

    New Labelling rules by US FDA for Indian Drug Manufacturers to help pregnant and breastfeeding women

    Many of the Pregnant and breastfeeding women do not have access to details regarding the prohibited drugs which could result

    Traning by German homeophaths to improve homeopathy medicine manufacturing

    Indian homeopathy medicine manufacturers will be imparted training by German Homeopaths to improve the standard operating procedures and improve quality of products

    BOI(TheBankOfIndustry)boosting the local manufacturing of drugs in Nigeria

    The bank of Industry is the oldest and most successful development finance institution in Nigeria. It is boosting the local manufacturing

    Form 483 issued to Hovione API facility in Portugal

    US FDA carried out a pre-approval inspection at Hovione API facility in Loures, Portugal covering two NDA filings.

    GMP certification for testing drug substances and drug products to Spinovation Analytical

    GMP certification have been awarded to Spinnovation Analytical by Dutch Healthcare Inspectorate and hence Spinnovation have been certified.


    Dec 16, 2014

    Resemblance of Indian GMP Requirements for Medical Devices with ISO 13485

    Recently Indian Central Standard Drug Control Organization (CDSCO) has asked for comments on draft revisions to Schedule M-III till 17

    Commission Delegated Regulation on GMP for API'S published in the official journal of the EU (European Union))

    "Commission Delegated Regulation (EU) No 1252/2014" has been published in the Official Journal of the European Union

    Drug Establishment License Issued by Health Canada to VANC Pharmaceuticals

    Drug Establishment Licence has been issued to VANC Pharmaceuticals Inc by Health Canada. The licence number is 102220-A

    Elaboration of training materials on ICH Q3D by ICH Working Group

    According to the requirement of Article 47 of Directive 2001/83/EG (Community code relating to medicinal products for Human Use)

    Potentially Fatal Skin Reactions associated with Ziprasidone-Manufacturer required to add new label by US FDA

    Ziprasidone is an atypical antipsychotic drug used to treat schizophrenia and bipolar I disorder. A warning has been issued by US FDA that the antipsychotic drug ziprasidone

    Anti-hypertension drug Amlodipine Besylate tablets recalled by Cadila in the US market

    Cadila Healthcare Ltd is recalling 5,144 bottles of the drug Amlodipine Besylate tablets in the US market. According to the information available on the USFDA website.

    Indian Regulators need to do more in case of Indian pharmaceutical companies

    Indian generic drug manufacturers were in headlines from last year till date on account of constant alerts from international drug regulators.


    Dec 10, 2014

    CDSCO seeking input on draft revisions to GMP on medical devices

    Schedule M-III of the Indian Drug and Cosmetic Act, describes good manufacturing practices (GMPs) for medical devices. Indian Central Standard

    Ranbaxy received warning letter from German Regulators

    Recently Ranbaxy has faced a lot of criticism and received warning letters from western regulators such as USFDA regarding non-compliance

    Ban on Ranbaxy's Dewas Products by German Regulators expand to entire European Union

    Drugs produced at Ranbaxy’s Dewas Plant have been barred from export to all member countries of the European Union for non-compliance

    WHO cGMP Certification awarded to May and Baker

    May and Baker is a Nigeria Based Pharmaceutical Company which has been granted cGMP certification by WHO on account

    Call for feedback by EMA on plans to require drug makers to state whether their drugs contain solubility-enhancing cyclodextrin excipients

    Call for feedback by EMA on plans to require drug makers to state whether their drugs contain solubility-enhancing cyclodextrin excipients

    Thoughts by Amgen and Pfizer on draft guidance on Biosimilars by EMA

    The draft guidance on EMA stated that “scientific principles of bio similar comparability exercise are based on those applied for evaluation

    Addendum 2015 to Indian Pharmacopoeia - 2014 published

    Recently Addendum 2015 to Indian Pharmacopoeia 2014 was released on 28 Nov 2014 by Sh. Lov Verma, Secretary Health & Family Welfare and Chairman


    Dec 02, 2014

    GMP Approval given to Beximco Pharma

    Beximco Pharmaceuticals is a generic manufacturer of pharmaceutical products and Active Pharmaceuticals in

    Hospira UK limited has recalled a number of batches of Mitoxanthrone due to a number

    Toronto Generic Drug giant Apotex had sued Health Minister Rona Ambrose over ordering of import ban on apotex products

    Cosmetics GMP Certification achieved by Clariant for all dedicated sites

    Clariant is a world leader in speciality chemicals which has successfully completed global ISO22716 and EFfci Cosmetics Good Manufacturing

    USFDA has given 483 to API Plant of Dr Reddy's Ltd situated in Srikakulam

    Dr Reddys Laboratories have got nine inspectional observations in a recent inspection by the US FDA at the API

    Final Guideline published by EMA (European Medicines Agency) on setting

    Final version of the guideline which sets the exposure limits of products manufactured in the so called shared facilities (multipurpose) has now been published


    Nov 25, 2014

    Ranbaxy's fight over generics with US FDA fail to block rivals

    Ranbaxy filed lawsuit against USFDA on 11 Nov 2014 in the District of Columbia in the US over withdrawing tentative approvals

    Surprise Inspection at Dr Reddy's Vizag Plant by US FDA

    Surprise Inspection is being conducted by US FDA at Dr Reddy's Laboratories unit located at Vishakhapatnam

    Health Canada's Ban on drugs manufactured by Apotex in India is being said "unlawful" by Apotex

    Toronto Generic Drug giant Apotex had sued Health Minister Rona Ambrose over ordering of import ban on apotex products

    Announcement of accepting industry feedback by ANVISA following Brazilian GMP Inspections

    According to an announcement on the ANVISA website medical device manufacturers will now be able to submit a feedback form to the regulator

    Recall of Potassium Chloride Injection (10 mEq per 100 mL by Baxter)

    Voluntary recall of one lot of highly concentrated potassium chloride injection 10 mEq per 100 mL has been made by Baxter International due


    Nov 17, 2014

    Warning given to Gujarat Based Plant of Cadila Pharma over manufacturing deficiencies

    Manufacturing issues such as having more than the allowable number of impurities that did not

    Successful Completion of USFDA inspection by Shasun Pharmaceuticals Ltd

    Serious violations were found at two dozen Canadian drug facilities. Non compliance was found

    FDA has announced major reorganization which will affect GMP inspections

    Plans for major reorganization has been announced by FDA which will become effective on January 2015

    Inspection trend data from 2013 published by MHRA Laboratories Ltd.

    Inspection trend data report from 2013 have been published by MHRA which also includes longer term

    Revised Draft of Supplementary Guideline for non-sterile process validation published by WHO

    The revised draft of the Supplementary Guideline on Good Manufacturing Practices: Validation.

    Corrosion Control Important and Management important for Zero Defect Zero Effect Manufacturing

    In CORCORN 2014 which is a four day international conference for exchanging ideas between the experts and manufacturers


    Nov 12, 2014

    Major Guideline on Biosimilars finalized BY EMA

    Long awaited guideline on biosimilars with recommendations to market in EU has been finalized by EMA

    Norms on conditions to delay and deny drug inspection issued by USFDA

    A guidance has been issued by US FDA to pharma and biotech industry on the circumstances that constitute

    Thousands of drug companies of CANADA violating the law

    Serious violations were found at two dozen Canadian drug facilities. Non compliance was found

    Release of Regulatory Data by EMA may have impact for Journals and Research Synthesis

    Final version of policy on release of CSRs of Trials for marketing authorization holders submitted by

    USFDA Approval Granted for manufacturing and marketing Fenofibrate Capsules To Ranbaxy Laboratories Ltd.

    US FDA has granted approval to Ranbaxy Laboratories Ltd for manufacture and marketing of Fenofibrate USP 43 and 130 mg.

    Drug alert notice to GlaxoSmithKline for Zovirax Eye Ointment by MHRA

    Drug alert has notice has been issued by MHRA for Zovirax Eye Ointmentwhich is being manufactured by GlaxoSmithline.


    0ct 28, 2014

    Limited Manufacture of Guinea-Variant Ebola Therapeutic by Tekmira Pharma

    Ebola Guinea Variant is the viral variant which is responsible for the Ebola epidemic in West Africa.Tekmira Pharma has

    UK has seized many of the illegal dental equipments

    The Medicines and Healthcare Regulatory Agency (MHRA) found in an investigation that a large number

    Health Canada backtracking regulatory actions on Apotex Banned Drugs

    Health Canada is reconsidering its actions taken to ban all the products manufactured at Apotex and IPCA

    GMP Compliance requirements posing challenges to Big Pharma Companies in Personalized Medicine

    Commercial scale production of personalized drugs is a challenge as GMP Production involves cost due to regulatory

    Import Refusal By FDA due to labeling violations in more than 5000 products in 2014

    Approximately 5029 labeling violations on products offered for import from foreign countries was identified

    US FDA issued warning letter to Portugal Manufacturing Unit of Hikma Pharmaceuticals Inc.

    US FDA inspected the Portugal Manufacturing Unit of Hikma Pharmaceuticals Inc in Mar 2014.The warning


    0ct 17, 2014

    Final Concept Paper Published by ICH for a new ICH Q12 guideline

    ICH has just published a Final Concept Paper for a new ICH Q12 guideline: Technical and Regulatory Considerations

    Final Guidance on Custom Medical Devices issued by FDA

    A new final guidance document has been released by US FDA for the manufacturers of

    Ban on the import of all drug and drug ingredients manufactured..

    Import of all the drug and drug ingredients have been banned by Health Canada which are being manufactured by two

    GVK Biosciences under the scanner of European Medicines Agency

    Findings related with noncompliance to GCP following an inspection by French Medicines Agency have led EMA

    Recall of Doxorubicin Hydrochloride 2mg/ml (20mg/10 Ml) pegylated liposomal concentrate

    The Philippine subsidiary of Merck Sharp and Dohme informed the FDA about the recall of Doxorubicin Hydrochloride

    US FDA alert for import of one of the skin care product to Strides Acrolab

    Strides Acrolab is a Bangalore Based pharmaceutical company.US FDA has put alert on one of the skin care product

    Recall of Unexpired Sterile Products in Oregon and Washington due to Sterility Assurance

    Certain Unexpired human and veterinary sterile products which were manufactured from July 1, 2014 through September

    Recall of Life Care Flexible Intravenous Solutions by Hospira, Inc due to potential for leakage

    Certain lots of several products in its Life Care line of flexible intravenous solutions are being voluntarily

    Cannabics Pharmaceuticals gets GMP Compliance

    Cannabics Pharmaceuticals has achieved Good Manufacturing Practices (GMP)

    Aurobindo Pharma obtains USFDA approval for Amoxicillin

    Aurobindo Pharma Ltd received final approval from the US Food & Drug Administration (USFDA) to manufacture

    EU GMP inspectors found 26 GMP deficiencies at Chinese API Manufacturer Hebei Dongfeng Pharmaceuticals.

    EU GMP inspectors found 26 GMP deficiencies at Chinese API Manufacturer Hebei Dongfeng Pharmaceuticals.

    WHO publishes New Version of Guide regarding the Principles of GMP.

    WHO publishes New Version of Guide regarding the Principles of GMP.

    Maximaa Systems inaugurates WHO-GMP compliant manufacturing facility

    Maximaa Systems inaugurates WHO-GMP compliant manufacturing facility .


    Oct 3, 2014

    USFDA Proscribed Two Indian Manufacturing Units on GMP violations.

    The succession of banning imports on Indian Manufacturing Units is not desisting.

    'Alkaloid' plant receives GMP certification

    Macedonian pharmaceutical company 'Alkaloid' has received a GMP certificate from

    Health Ministry to Alter ScheduleM-III for medical devices

    The Union health ministry is aiming to revise the Schedule M-III for medical devices under

    GMP Non-compliance Reports available in EudraGMDP

    A GMP Non-Compliance Report has come from the Bulgarian Authority for Vetprom AD regarding finished

    New EU-GMP Chapter 8 published: Complaints and Recalls

    New EU-GMP Chapter 8 published: Complaints and Recalls

    Sep 19, 2014

    Health Canada bans shipment of products from Ipca Laboratories

    Health Canada has asked Ipca Laboratories, an Indian pharma major, to voluntarily stop shipment of

    Sun Pharma's subsidiary Taro recalls warfarin

    Sun Pharma's American subsidiary Taro has recalled its leading blood clot drug Warfarin Sodium from the market after the

    Natco Pharma and Orchid Chemicals get warning letters from US FDA

    Natco Pharma and Orchid Chemicals and Pharmaceuticals have received an adverse observation report

    Hospira recalls Heparin due to presence of human hair in a product

    Hospira initiated a voluntary nationwide recall of one lot of Heparin Sodium, 1000 USP Heparin

    Baxter voluntary recalls Potassium Chloride Injection due to labeling error

    Baxter International is voluntarily recalling one lot of Potassium Chloride Injection 10mEq per 100mL

    12 Sep, 2014

    Getz Pharma obtains WHO pre-qualification certification

    Getz Pharma obtains WHO pre-qualification certification

    Number of medical device recalls lowest in two years

    Number of medical device recalls lowest in two years

    Sun Pharma faces surprise audit by the USFDA

    Sun Pharma faces surprise audit by the USFDA

    Indian pharma companies looking at WHO-GMP norms for quality standards

    Indian pharma companies looking at WHO-GMP norms for quality standards

    Martin Avenue Pharmacy recalls all sterile compounded preparations

    Martin Avenue Pharmacy recalls all sterile compounded preparations.

    5 Sep, 2014

    Ajinomoto Althea receives EU GMP Certification

    Ajinomoto Althea receives EU GMP Certification

    Boehringer Ingelheim recalls cancer drug due to contamination issues

    Boehringer Ingelheim recalls cancer drug due to contamination issues

    Meggle Group receives EXCiPACT Certificate from SGS

    Meggle Group receives EXCIPACT Certificate from SGS

    Wockhardt recalls Metoprolol Succinate for third time due to dissolution failure

    Wockhardt recalls Metoprolol Succinate for third time due to dissolution failure

    GlaxoSmithKline Philippines Inc. voluntarily recalls eye drops

    GlaxoSmithKline Philippines Inc. voluntarily recalls eye drops

    29 Aug, 2014

    Chinese pharmaceutical manufacturer receives import alert from US FDA

    Chinese pharmaceutical manufacturer receives import alert from US FDA

    Teva recalls Parkinson's drug due to potency issues

    Teva recalls Parkinson's drug due to potency issues

    Injunction passed against dietary supplement manufacturer

    Injunction passed against dietary supplement manufacturer

    Alexion Pharmaceuticals gets Form 483 again by the FDA

    Alexion Pharmaceuticals gets Form 483 again by the FDA

    OEP Philippines Inc. initiated voluntary recall of Nicorandil

    OEP Philippines Inc. initiated voluntary recall of Nicorandil

    22 Aug, 2014

    Marck Biosiences receives warning letter from USFDA due to GMP violations

    Marck Biosiences receives warning letter from USFDA due to GMP violations

    Croda receives EFfCI GMP Certification for cosmetic manufacturing site

    Croda receives EFfCI GMP Certification for cosmetic manufacturing site

    Apotex recalls Apo-Mycophenolic Acid due to labeling error

    Apotex recalls Apo-Mycophenolic Acid due to labeling error

    Glanbia self-affirms GRAS on the basis of FDA regulations

    Glanbia self-affirms GRAS on the basis of FDA regulations

    Sun Pharma recalls 500,000 bottles of Cephalexin capsules from US

    Sun Pharma recalls 500,000 bottles of Cephalexin capsules from US


    Aug 15, 2014

    NPA certifies Paragon laboratories for GMP

    Paragon Laboratories is a contract formulator, manufacturer and packager of nutritional and dietary

    Amgen recalls syringes of Aranesp due to presence of visible particulates

    Amgen initiated a voluntary recall on June 26, 2014 for nine packaged lots

    Indian regulator issues uniform regulatory procedures for CoPP and GMP inspections

    India's Central Drugs Standard Control Organization (CDSCO) has

    Ipca Labs stops shipments to US from Ratlam manufacturing unit

    USFDA listed six serious deviations on inspection done between

    Number of drug recalls by USFDA rising

    Recalls of pharmaceutical products have increased in recent years, and ss



    Aug 1, 2014

    US FDA approves Novasep’s manufacturing sites in France after inspections

    Novasep is a French company offering development services, contract

    European Pharmacopoeia Commission declares strategy about elemental impurities & implementation of ICH Q3D guideline

    The ICH Steering Committee announced that it planned to move its guideline for

    New York Dietary Supplement Maker recalls Adulterated Supplements

    The U.S. District Court of New York has entered a consent decree of

    FDA warning letter to Chinese API Manufacturer for cGMP and Misbranding Violations

    The US Food and Drug Administration (FDA) issued a Warning Letter to Zhejiang Jiuzhou

    New FDA regulations for baby formula manufacturers

    The U.S. Food and Drug Administration (FDA) recently finalized new stricter

    Unique Pharmaceuticals recalls all sterile drug products from US market

    Unique Pharmaceuticals Ltd of Texas has recalled all non-expired

    Jul 25, 2014

    IOL Chemicals gains Good Manufacturing Practices Certificate from German Authority

    IOL Chemicals and Pharmaceuticals Limitedhas obtained "Certificate of Good

    Zimmer recalls over 40,000 NexGen Knee Implant

    Zimmer Holdings, Inc. has initiated a voluntary recall of 41,180 stemmed tibial

    ICH M7 Guideline entering implementation period (Step 5)

    The ICH M7 Guideline on Assessment and Control of DNA Reactive

    American Health Packaging announces nationwide recall of Ibuprofen and Oxcarbazepine Tablets

    American Health Packaging has recalled one lot of 600-mg ibuprofen tablets

    NAFDAC guides herbal medicine practitioners to follow GMP guidelines

    The National Agency for Food, Drug Administration and Control (NAFDAC)

    Unique Pharmaceuticals recalls all sterile drug products from US market

    Unique Pharmaceuticals Ltd of Texas has recalled all non-expired

    Jul 18, 2014

    Sun Pharma recalls 40,000 bottles of Venlafaxine Hydrochloride in US

    Sun Pharma's US subsidiary Caraco Pharmaceutical Laboratories has initiated

    Amoxicillin Actavis recalled due to glass fragments found in two bottles

    Glass fragments found in two bottles of the Actavis brand of amoxicillin oral

    Italian API Maker Receives FDA Warning Letterdue to lack of data control

    US FDA issued a Warning Letter on 7th July to Trifarma for violating Good Manufacturing

    GSK recalls Panadol® Advance in Puerto Rico

    GlaxoSmithKline Consumer Healthcare is one of the world's largest over-the-counter

    Baxter issues worldwide recall of IV solutions due to visible particulate matter

    Baxter International Inc. is voluntarily recalling four lots of intravenous (IV) solutions

    Jul 11, 2014

    FDA announces cGMP guidances on drug compounding

    The U.S. Food and Drug Administration (FDA) has released five documents

    Shasun Pharma successfully completes US and Mexican drug regulator inspection

    Shasun Pharmaceuticals Ltd., a global pharmaceutical organization, has successfully

    Sun Pharmaceuticals recalls 200 cancer drug vials from the US market

    Sun Pharmaceutical Industries Ltdinitiated voluntary recall of 200 vials of

    Animal research facility of Frontier Mediville gets approval

    Frontier Mediville has got the approval by the Ministry of Environment & Forests

    Pfizer voluntarily recalls bottles of Pristiqdue to tablet mix-up

    Pfizer has initiated a voluntary recall for 220,761 bottles of the antidepressant Pristiq (desvenlafaxine)

    Crisil: Indian drug makers must invest in compliance due to stricter USFDA enforcements

    India has the largest number of FDA-approved drug manufacturing plants

    Jul 4, 2014

    FDA recalls injectable Vitamin Products distributed by Medical Supply Liquidators

    The U.S. Food and Drug Administration (FDA) has warned health care professionals

    Beximco Pharmaceuticals Limited gains GMP approval from TFDA

    Beximco Pharmaceuticals Limited (BPL) has become the first Bangladeshi

    Bristol-Myers Squibb recalls Coumadin Injection due to visible particulate matter

    Bristol-Myers Squibb, a global biopharmaceutical company has issued a voluntary recall

    Teva's human growth hormone for children recalled due to oil leak into it

    New Jersey basedFerring Pharmaceuticals has voluntarily recalled 8 lots

    After many regulatory bans Ranbaxy gets FDA approval for producing Generic Diovan

    Indian drug manufacturer, Ranbaxy Laboratorieshas received approval from the U.S. Food

    Jun 27, 2014

    Swipha obtains WHO GMP certification

    Swiss Pharma Nigeria Limited (Swipha) has announced its WHO GMP certification

    FDA asks for more warnings on Testosterone products

    The U.S. Food and Drug Administration said that all manufacturers of

    Guilin Pharma’s first WHO certified API: Artemether

    Guilin Pharma has announced its first World Health Organization (WHO) product

    Karnataka Drugs Control seizes 28 inferior standard drugs and issues warning

    Karnataka drugs control department recovered 28 not-of-standard quality

    Britain's biggest drug maker, GlaxoSmithKline warned by US FDA to review its manufacturing practices

    GlaxoSmithKline was warned by US FDA to review its manufacturing operations

    US FDA’s inspection of Divis Labs' Hyderabad plant successfully completed

    Divis Laboratories Ltd. had a successful inspection by the US FDA from 16th

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