Institute of Good Manufacturing Practices India

Pharma GMP Newsletter


WHO raises an alert on cough syrups manufactured by Marion Biotech

The World Health Organisation (WHO) has raised a warning on two cough syrups manufactured by Uttar Pradesh-based Marion Biotech Pvt Ltd, which were considered as the ca


FDA Warning Letter issued for Data Integrity and Good Documentation Practice Failures

The U.S. American company Kari Gran Inc. received the U.S. FDA Warning Letter pertaining to its site inspection in July 2022.

The s


FDA Warning Letter to Glenmark for Laboratory Issues

Glenmark Pharmaceuticals Limited received a Warning letter from the U.S. FDA (Food and Drug Administration). The Warning Letter summarizes substantial violations of Cur


European Medicines Agency necessitates Clinical Trials Information System in 2023

Starting 31 January 2023, the new Clinical Trials Information System (CTIS) will become mandatory as per EMA. CTIS functions as a single entry point of contact for the


Expert Task Force issues the latest version of the CCS Guideline

After February, the ECA Foundation's CCS Task Force issued a fresh version of a Contamination Control Strategy (CCS) Guideline to help its members meet this requirement


European Commission: Position paper on 'hybrid audits'

In early December, the European Commission's MDCG (Medical Device Coordination Group) published a definition of 'hybrid audits'.



ICH: Final Q13 Guideline on Continuous Manufacturing

The ICH Q13 Guideline on "Continuous Manufacturing of Drug Substances and Drug Products (Step 4)" was eventually adopted during the International Council for Harmonisat


EC: Modified Labelling Requirements for IMPs

With the publishing of Delegated Regulation 2022/2239, the European Commission has issued the revised and amended labelling prerequisites for unauthorized investigation


Access Consortium Good Manufacturing Practice (GMP) Statement

Good Manufacturing Practice (GMP) certifies that medicinal products are regularly produced and controlled to the quality standards relevant to their purposeful use or a


Standard for Serialisation and Data Matrix Codes begins on 1 January 2023

Medicines-Standard for Serialisation and Data Matrix Codes Therapeutic Goods Order 2021 (TGO 106) begins on 1 January 2023.

If Medi


European Medicines Agency (EMA): Q&A Documents on Centralized Procedures revised again

The Questions & Answers (Q&A) documents pertaining to centralized marketing authorization procedures, which were revised in June, have now been updated and publ


FDA issues Warning Letter to Abraxane Manufacturing unit for Sterility Issues

The FDA issued a Warning Letter to Abraxis Bioscience LLC in Phoenix, United States, on October 31 2022. As per the warning notice, the FDA’s inspection of the co


The FDA issues Warning Letter to a Sterile Medicinal Products Manufacturer in the US

The FDA issued a Warning Letter to Cangene BioPharma, LCC, in Baltimore, a subsidiary of Emergent BioSolutions. Significant deviations from Current Good Manufacturing P


"Magic Heal" Manufacturer Receives FDA Warning Letter

The U.S. FDA (Food and Drug Administration) issued a Warning Letter dated March 14, 2022, to an American manufacturer- Premier Trends LLC. During a check from September


Inefficient OOS Analyses lead to FDA Warning Letter

Recently the U.S. FDA (Food and Drug Administration) gave a warning letter to Professional Disposables International, Inc, located in Orangeburg, New Y


USFDA issues a warning letter to Aurobindo Pharma for its API facility

Aurobindo Pharma received a warning letter from the USFDA for its Hyderabad-based Unit I, an active pharmaceutical ingredient (API) manufacturing facility.


FDA issues Warning Letter to Laboratorio Pharma International SRL for Lack of Stability Data and Specifications for APIs

A recent Warning Letter from FDA to Laboratorio Pharma International SRL describes fundamental GMP deficiencies in the quality control area at its manufacturing facility of topical analgesics.


FDA issues Warning Letter highlighting the importance of Analytical Methods Validation and System Suitability Tests

The USFDA (Food and Drug Administration) inspection of the drug manufacturing facility, BBC Group Limited, China, from March 22 to March 26, 2021, revealed significant violations of Current Good Ma


WHO ‘identifies issues’ at Sputnik V vaccine manufacturing plant in Moscow

The WHO (World Health Organization) uncovered some problems at a Sputnik V vaccine filling site in Moscow related to the implementing an appropriate Environmental Monitoring Program to monitor and


COVID-19 Packaging Changes: Glass Vials and Stoppers- New FDA Guidance

COVID-19 injectable products may need some changes to the primary packaging components (e.g., glass vials and stoppers). The supply chain issues are affecting vaccine availability. Hence, the U.S.


US health regulator issued three observations for New York API manufacturing plant: Dr Reddy's Lab

Dr Reddy's Laboratories, an integrated pharmaceutical company, said that the US health regulator had issued a Form 483 with three observations after inspection of its manufacturing facility in Midd


Draft Guidance on GMP for Investigational Radiopharmaceutical Products: WHO/IAEA

WHO published a 31-page draft guideline, "GMP for investigational radiopharmaceutical products," in March 2021. It offers recommendations for minimum standards in the manufacture


Vivimed's FDF facility in Jeedimetla: Ukraine GMP approval


Vivimed Labs Limited declared that its FDF manufacturing facility located in Jeedimetla, near Hyderabad, has been approved and accredited with GMP certification effective September 2


Approved changes in inspection report for compliance with GMP: Ministry of Justice


The Ministry of Justice of Russia registered an order of the Ministry of Industry and Trade of Russia dated 29.01.2021 No. 284, which amends Annex 2 to the order of the Ministry of I


Warning Letter to Allay Pharmaceuticals: FDA criticizes Supplier Qualification


Guidance document released for monographs drafting & formatting for Indian Pharmacopoeia: IPC

The Indian Pharmacopoeia Commission (IPC) issued the Guidance Document for Drafting and Formatting Monographs for Indian Pharmacopoeia (IP) for guidance to the stakeholders, including drug analysts


Inadequate Quality Unit, Laboratory Controls, Sampling Plans, and Stability Program: FDA Warning Letter to Clientele, Inc.


The U.S. FDA (Food and Drug Administration) sent a Warning Letter to Clientele, Inc. The firm produces OTC topical drug products that include sunscreen act


Virtual inspections because of COVID-19 pandemic: Indian pharma industry calls on USFDA


Indian pharma industry urged the US FDA to conduct inspections of their plants and facilities virtually in the wake of the COVID-19 pandemic.

The USFDA, in March, had suspend


USFDA issued a warning letter to the New Jersey unit of Aurobindo Pharma's subsidiary


The United States Food and Drug Administration (USFDA) issued a warning letter to the drug manufacturing company Aurobindo Pharma's step-down subsidiary. The warning was issued to th


FDA issues warning letter to Coupler Enterprises for GMP deficiencies in packaging


US-FDA recently issued a Warning Letter to Coupler Enterprises, a pharmaceutical manufacturer, for GMP deficiencies in its packaging and quality assurance. The warning is related to


Mylan's Indian Unit Received USFDA Warning Letter


Mylan NV received a warning letter from the U.S. FDA for failure in ensuring the purity of active pharmaceutical ingredients made at one of its plants in Pashamyl


Warning Letter closed for Dr Reddys Labs’ three Sites: USFDA


The US health regulator closed the  warning letter of a pharmaceutical company, Dr Reddy's Laboratories, for three of its sites in Andhra Pradesh and Telangana, after due evalua


High levels of NDMA detected in Metformin Hydrochloride, prompted product recall


Bayshore was notified by U.S. Food and Drug Administration (USFDA) that certain batches of Metformin Hydrochloride Extended-Release Tablets, USP 750mg, and USP 500mg when tested for


FDA furnishes guidelines for the quantity of Bioavailability and Bioequivalence samples retained under 21 CFR 320.38(c)


The FDA has released compliance guidelines on reserve samples used in the bioavailability and bioequivalence studies.

The guidelines:-



Tender Corporation receives a warning letter by USFDA for unapproved HPLC Injections and OCT products


Tender Corporation, the firm that manufactures and distributes OTC products receives a warning letter from The U.S. Food and Drug Administration. The FDA investigators conducted


Warning letter issued to Stason Pharmaceuticals for violating current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.


The USFDA inspected the drug manufacturing facility of Stason Pharmaceuticals, Inc., and observed significant violations of current Good Manufacturing Practice regulations for finish


USFDA furnishes new guidelines on quality considerations for clinical research with Cannabis and Cannabis-derived compounds


Cannabis is the genus of the plant belonging to the Cannabaceae family. The three main species of Cannabis are C. sativa L., C. indica, and C. ruderalis. These spe


Voluntary recall of ChloraPrepTM Applicator due to possible fungal contamination


BD (Becton, Dickinson and Company), a leading global medical technology company announced voluntary recall for its product ChloraPrepTM 3ml applicator due to fungal c


Warning letter issued to Eskbiochem S.A. by USFDA, regarding the distribution of substandard and dangerous hand sanitizers.


FDA reiterates hand sanitizers comprising low levels of ethyl alcohol or isopropyl alcohol with the dangerous presence of methanol manufactured by Eskbiochem S.A. de C.V.



Cadila's Baddi unit was furnished with USFDA Form 483 with zero observations


Cadila Healthcare Limited declared that US Food and Drug Administration (FDA) furnished Form 483 with zero observations to the Baddi unit of the company.


Hyderabad facility of SMS Pharma clears USFDA inspection


SMS Pharmaceuticals has successfully completed its Hyderabad’s testing facility regulatory inspection by the US drug regulator.

The United States Fo


FDA issues warning letter to manufacturing facility of KVK-Tech


The US Food and Drug Administration (FDA) have issued a warning letter to drug manufacturing facility of KVK-Tech following an audit in April 2019.  


Aurobindo Pharma receives EIR from USFDA for Hyderabad facility


Aurobindo Pharma Limited stated that it has gained the Establishment Inspection Report (EIR) with Voluntary Action Initiated (VAI) status from US Food and Drug Administrati


API Manufacturing Facility for Biocon Small Molecules Completed its Post -Approval and GMP USFDA Inspection


Biocon, a drug API maker, has announced that the U.S. Food and Drug Administration (FDA) performed a Post-Approval and GMP inspection of Small Molecules API Manufacturing F


Jadcherla facility of Shilpa Medicare receives 15 observations from USFDA


Shilpa Medicare has got 15 observations from US Food and Drug Administration (FDA) for the finished dosage formulation facility (sterile and non-sterile) for Jadcherla faci


USFDA concluded evaluation at Puducherry & Mangaluru facilities of Solara


A leading active pharmaceutical ingredient (API) provider, Solara Active Pharma Science Ltd., declared that the US Food and Drug Administration (FDA) have done two successf


USFDA retracted status of VAI for Unit-IV plant of Aurobindo Pharma


The US Food and Drug Administration (FDA) revoked the status of ‘Voluntary Action Initiated’ (VAI) furnished to Unit-IV plant of Aurobindo Pharma in Hyderabad.<


Alkem Labs Baddi facility receives 2 USFDA observations


Alkem Laboratories Limited has achieved 2 observations from US Food and Drug Administration (FDA) for the facility in Baddi of company in Himachal Pradesh.

The company stated


EU GMP Annex 1: 2nd Draft on Sterile Manufacture


A 1st targeted consultation to the Annex 1 of the EU GMP Guide permitted about 140 companies and organizations to comment. The drafting group moved ahead with more than 6200 lines of


Reopening of investigation by USFDA of unit 4 facility of Aurobindo


Reopening of investigation of Aurobindo Pharma’s Unit-4 manufacturing facility by the US Food and Drug Administration, days after the regulator had declared that it h


Biocon receives three observations from USFDA for insulin facility in Malaysia


Biocon on Saturday stated that it has gained 3 observations from the US health regulator following inspection of its facility of insulin manufacturing in Malaysia.

The US Foo


FDA Warning Letter for getting drugs which are potentially unsafe


The U.S. Food and Drug Administration (FDA) have furnished a warning letter to Greenbrier International, Inc., doing business as Dollar Tree, for getting drugs which are po


As per the Warning Letter, FDA criticizes Supplier Qualification


Supplier Qualification and the respective contracts in outsourcing activities are always hot debated topics in inspections. The U.S. Food and Drug Administration (FDA) rece


US FDA inspection at Panoli, Gujarat facility completed successfully of J. B. Chemicals & Pharmaceuticals Ltd


J. B. Chemicals & Pharmaceuticals Ltd’s US FDA granted solid oral dosage forms formulations manufacturing facility at Panoli, Gujarat has successfully completed p


Form 483 to Biocon's API facility: USFDA


A pre-approval inspection and good manufacturing practice examination was conducted by the US health regulator at the API manufacturing facility of Biocon. The company has received a


FDA furnishes warning letter to Health Pharma for violations of cGMP


The US Food and Drug Administration (FDA) has issued a warning letter to Health Pharma regarding its manufacturing site in New Jersey, US, after violations of current good manuf


Multiple manufacturing units of Lupin now under USFDA scanner


Drug major manufacturing capabilities of Lupin have come under the scanner of the US drug regulator, as it has located deficiencies across multiple sites in recent inspections.


USFDA categorizes inspection of Tarapur facility of Lupin as Official Action Indicated


Lupin Ltd on Monday stated the US health regulator has alerted that its Tarapur manufacturing facility may be subjected to regulatory actions.

The company has obtained a comm


Lupin receives two observations from USFDA for Nagpur facility


Lupin, a drug firm on Saturday stated that it has obtained two observations from the US health regulator following the inspection of its Nagpur manufacturing facility.



GPT Pharma obtains US FDA warning for violations of cGMP at Hyderabad plant


The United States Food and Drug Administration (FDA) has furnished warning letter to drug firm GPT Pharmaceuticals for important violations of current good manufacturing practice (cG


EIR secured from USFDA by Pashamylaram facility of Suven Life Sciences


Suven Life Sciences Limited recently received the EIR following the renewal inspection by US health regulator at their facility in Pashamylaram near Hyderabad for the supply and


LifeSan Clinical Research obtains zero 483 observations from USFDA


A division of Centaur Pharmaceuticals Pvt Ltd, LifeSan Clinical Research has obtained zero Form 483 observations from US Food and Drug Administration (FDA). The company has unde


Baddi manufacturing unit of Glenmark obtains GMP certificate from European regulator


Glenmark Pharmaceuticals Ltd has obtained Certificate of good manufacturing practice (GMP) from European drug regulator for its Baddi unit in Himachal Pradesh. Glenmark's Baddi


Zero observation obtained by Hikal from US FDA for Panoli facility


Hikal Ltd has successfully completed USFDA audit at Panoli, Gujarat, with zero Form 483 observations.

The inspection was conducted between September 9 and 13, 2019.
As s


Torrent Pharma warned by USFDA for significant violations at US plant


The US health regulator has warned Torrent Pharmaceuticals’ US-based subsidiary for violating good manufacturing practices, including the unavailability of properly designed eq


USFDA found cGMP violations were found by at Cadila’s Moraiya plan


Vital violation of current Good Manufacturing Practice (cGMP) regulations was found by the health regulator of US for finished pharmaceuticals at Cadila Healthcare’s Morai


US FDA EIR to Lupin for Nagpur facility


Lupin Limited received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for its Nagpur facility. Inspection of the facility was done by the US


Torrent Pharma red flagged by USFDA for violating norms for Indrad Facility


Torrent Pharma is now red flagged by USFDA for significant violations of current good manufacturing practice (cGMP) regulations for its Indrad facility in Gujarat.

An inspect


Torrent Pharma recalls 74k bottles of hypertension drug from US


As per the reports of the US health regulator, Torrent Pharma Inc is recalling 73,896 bottles of hypertension treatment tablets from the US and Puerto Rico on the basis of deviations


USFDA observations to Aurobindo Pharma's Unit-VII regarding potentially misleading documents


An inspection has been conducted by the US Food and Drug Administration officials in a manufacturing facility of Aurobindo Pharma. The FDA has observed several discrepancies regardin


GMP certification for Lupin's unit-2 Mandideep facility by Japan's PMDA


Good manufacturing practice (GMP) certificate has been received by Lupin from Japan's Pharmaceutical and Medical Devices Agency (PMDA) for its drug manufacturing facility at Mandidee


FDA Warning Letter for Refusal to Permit Inspection: Important parameters for Startups and Drug and Device Manufacturers


Current Good Manufacturing Practices (cGMPs) are mandatory enforced by regulators of the U.S. Food and Drug Administration (FDA), and must be executed and followed by manufacturers o


Mandideep facility of Lupin red-flagged by USFDA for CGMP violations


Lupin, a pharma firm was red flagged by the US health regulator for significant violations of the current good manufacturing practice regulations at its Mandideep facility in Madhya


USFDA cGMP surveillance clearance of Unichem Labs API facility in Kolhapur


Unichem Laboratories has successfully completed the US health regulator audit of its new facility at Kolhapur, Maharashtra without any observations.

The cGMP surveillance of


USFDA warning letter to Hangzhou Badi Daily Use Chemical Company

The U.S. Food and Drug Administration (FDA) conducted an inspection of Hangzhou Badi Daily Use chemical company, drug manufacturing facility located at Huzhou City, Zhejiang Province from March 19


Enprani Co., Ltd. Gets USFDA warning letter

Enprani Co., Ltd drug manufacturing facility located at Incheon, was inspected by the U.S. Food and Drug Administration (FDA) from March 11 to 15, 2019.

The warning letter was issued to com


Haw Par Healthcare Limited receives USFDA warning letter

USFDA inspection was done at Haw Par Healthcare Limited drug manufacturing facility located at Singapore, from February 25 to March 1, 2019.

Issued warning letter summarized the significant


EMA cGMP certification to Viralgen

The Viralgen receives the European Medicines Agency (EMA) cGMP compliance accreditation certificate and Spanish Agency for Medicines and Health Products (AEMPS) Pharmaceutical Laboratory authorizat


Open-ended AGES GMP certification wins by Rentschler Fill Solutions

The Austrian Agency for Health and Food Safety (AGES) has given the GMP compliance and pharmaceutical manufacturing license to the Rentschler Fill Solutions. It is a contact development and manufac


Three US FDA observations to Ipca Labs for Silvassa facility

The US FDA inspection for Silvassa facility of Ipca Labs conducted during 19-23 August 2019. It is the formulation facility of Ipca Labs.

The firms receive three US FDA observations in Form


Three US FDA observations to Ipca Labs for Silvassa facility

The US FDA inspection for Silvassa facility of Ipca Labs conducted during 19-23 August 2019. It is the formulation facility of Ipca Labs.

The firms receive three US FDA observations in Form


New Q&A’s added by FDA to lab control section-cGMP guidance

Three new questions and their answers are added by the USFDA to the laboratory Controls on Current Good Manufacturing Practices (cGMP) guidance. The instrument calibration standards, trial injectio


API facility of Natco Pharma gets 6 observations from the USFDA

The API facility based in Mekaguda Village, near Hyderabad receives six observations from the USFDA. The inspection was carried out between05-09 August 2019.

The received observations are m


Strides Alathur facility completes USFDA inspection with no observations

The Alathur facility of Strides based in Chennai has successfully completed the USFDA audit with zero observation. The inspection was done between 05August to 09August 2019 with no observation from


Lupin receives FDA EIR for Aurangabad facility


The USFDA has issued Establishment Inspection Report (EIR) for Lupin's Aurangabad facility. The USFDA inspection was carried out during 6 May 2019 till 15 May 2019.

The Auran


Manufacturing violations observed at Emcure Pharma Pune Plant: USFDA

The US FDA has issued a warning letter to Emcure Pharma for its Pune based plant. It was made due to violation of current good manufacturing practices (cGMP) by the organization.



Cadila Healthcare completes USFDA audit with zero observation

The USFDA has done the audit of Cadila Healthcare’s facility based at Ankleshwar in Gujarat. The facility is involved in the manufacturing of active pharmaceutical ingredients.

The US


Vials for hemophilia treatment recalled by Bayer due to mislabeling

After the fear of mislabeled vials, Bayer has voluntarily recalled 2 lots of 2000 IU vials (recombinant) containing Kogenate FS antihemophilic factor in the United States. Even though the labels in


Granules India’s inspection with one USFDA observation

Granules India completes the USFDA audit of its Bonthapally facility with one observation. It is amongst the world’s largest single site manufacturing plant of Paracetamol API by volume. The


Patients are advised not to use Herbal Doctor Remedies’ Medicines

The FDA has recommended that the patients should not use the drugs manufactured by Herbal Doctor Remedies, Monterey Park, California, because the conditions at the manufact