GMP News

Illegal Selling of CBD-Products: FDA Continues Issuing Warning letters

The FDA still warns companies for illegal selling Over-the-Counter CBD Products for pain relief including products listing CBD as an inactive ingredient.

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GDP-Non-Compliance-Report for German Wholesale Distributor

The Competent Authority of Germany (Bezirksregierung Düsseldorf) has entered a new GPD Non-Compliance Report dated into the EudraGMDP database due to serious GDP violations at a German wholesaler. The case involves trading of falsified medicinal products and storage of expired medicinal products in regular stock. Furthermore, there are doubts on the reliability of the Reponsible Person and the CEO due to an ongoing criminal procedure.

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FDA Warning Letter to Mexican Manufacturer based on Review of Documents

The U.S. Food and Drug Administration (FDA) recently published a Warning Letter to a Mexican firm whose facility is registered as a manufacturer of over-the-counter (OTC) drug products in the United States. The Warning Letter is not based on inspection findings from an onsite audit but on the review of documents that the company was required to send at the request of the FDA. The FDA found different serious deficiencies based on the submitted documents.

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Switzerland aims to Facilitate Access to Medicinal Cannabis

The Swiss Narcotics Act is to be amended. Among other things, the amendment provides that cannabis-based treatments can be prescribed directly by doctors without having to obtain an exceptional authorization from the Swiss Federal Office of Public Health. In addition, cultivation and export are to be permitted.

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Poor Documentation Practice caused U.S. FDA Warning Letter

In March 2021, the U.S. FDA issued a Warning Letter to a Chinese manufacturer of over-the-counter (OTC) drug products called "Foshan Biours Biosciences Co., Ltd." due to significant violations of cGMP regulations for finished pharmaceuticals.

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Revised Ph. Eur. Chapter 3.2.9. Rubber Closures

A general revision of Ph. Eur. Chapter 3.2.9 "Rubber Closures" has been proposed in Pharmeuropa 33.2. In particular the proposal includes changes to the sections regarding composition changes and extractable elements, functionality & fragmentation testing.

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Supplier Qualification for Packaging Material

USP´s Packaging and Distribution Joint Subcommittee posted a proposal for the development of a new General Chapter <1xxx> Supplier Qualifications.

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EMA: Revision of Q&A Documents regarding the Centralised Procedure

The latest versions of the two Q&A documents relating to the centralised procedure have each been supplemented by a question regarding the importation of finished medicinal products into the European Union.

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UK Recognition of EU/EEA Batch Testing does not end on 1 January 2023

A letter from the UK government to medicines and medical products suppliers extends the transitional phase for the recognition of EU batch tests beyond 2022.

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Rapid Revision and Implementation of Pharmacopoeial Monographs Concerning 5 Sartan Preparations

In the light of the recommendations made in CHMP's final assessment report on nitrosamine impurities in sartan preparations, the European Pharmacopoeia Commission has revised 2 general chapters and 5 API monographs in a rapid procedure. Read more here about which new requirements are specified in the updated sartan monographs.

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MHRA starts combined Distant / On-Site Inspections

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) is launching a sensible and likely workable approach to resuming domestic inspections - a combination of distant and on-site inspections.

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Post-Authorization Safety Studies - Recent Inspection Findings

The MHRA recently published inspection findings in the conduct of post-authorization safety studies (PASS). In particular, the agency observed significant breaches of the study protocol for the MAHs non-interventional PASS during inspection at a study site.

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How to Classify Changes to Ongoing Clinical Trials

The European Commission published an updated Version 3 of the Questions & Answers relating to the Clinical Trials Regulation. Amongst others, the new version covers the classification of changes to ongoing clinical trials.

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Reference Safety Information in Clinical Trials

The MHRA GCP inspectorate has continued to see non-compliance in reference safety information in clinical trials. In particular, the agency is still seeing unreported SUSARs and absence of adequate risk mitigation measures due to incorrect use of the RSI.

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Cannabis Glossary and GACP Revision

EMA´s Committee on Herbal Medicinal Products published the 2021 HMPC Work plan. Amongst others the HMPC plans to establish a Cannabis glossary and to revise the GACP guidelines.

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Sartan Medicinal Products: EMA's Assesment Report defines Nitrosamine Limits and Reporting Deadlines

In a final assessment report, the CHMP has published recommendations for marketing authorisation holders of medicinal products containing sartan. Read more here about the requirements for limit values of nitrosamine impurities and for risk assessments, as well as the deadlines to be met.

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New THC Threshold for Hemp Products

The German Federal Institute for Risk Assessment has issued a new statement recommending that the assessment of hemp-based food products be based on the EFSA-derived acute reference dose of 1 microgram Δ9-THC/kg body weight.

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Pharmacovigilance Inspection Metrics

The MHRA GVP inspectorate recently published their latest inspection metrics for the period from April 2019 to March 2020. The highest number of all findings in the reporting period related to risk management followed by quality management systems.

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Brexit: Pharmacovigilance Requirements for UK MAHs

The MHRA posted an updated guidance to become familiar with the pharmacovigilance requirements for UK marketing authorization holders.

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EU accepts MHRA inspections

The EMA has updated its Q&A document on the implementation of the Protocol on Ireland and Northern Ireland and clarified the recognition of inspections.

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FDA stops another Delivery of Hand Sanitizer at the US Border

The U.S. Food and Drug Administration (FDA) has once again stopped a delivery of hand sanitizers with too low alcohol content. The Mexican manufacturer received a Warning Letter.

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Is Medical Cannabis a Medicinal Product?

The Higher Regional Court (OLG) of Hamburg has decided, in the context of proceedings aimed at the issuance of an interim injunction against a wholesaler, that medical cannabis (cannabis flowers) is not (yet) a medicinal product at the wholesale level.

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

COVID-19 injectable products may need some changes to the primary packaging components (e.g., glass vials and stoppers) due to supply chain issues affecting their availability. Therefore, the FDA has issued a new guidance with recommendations for the appropriate reporting category and the content of postapproval change submissions.

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What is the FDA's Position on Concurrent Validation?

In the FDA Guidance for Industry on process validation, there is also a short section on concurrent validation. Concurrent validation should be used rarely, but may be possible if, for example, products are manufactured infrequently or medically necessary products are needed for short-term market supply. A recent Warning Letter underlines the guideline's statement that concurrent validation should be used rarely.

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Medical Gases: WHO publishes Draft Guideline

In February 2021, the WHO published the new Guideline "GOOD MANUFACTURING PRACTICES FOR MEDICAL GASES" on the manufacture, testing, storage and distribution of medical gases for comment. The reason for the WHO to create this new guideline is the increased demand for oxygen for ventilation due to the Corona pandemic.

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