GMP NEWS 2022

The U.S. FDA warns five companies for illegally selling food and beverage products containing cannabidiol (CBD). According to the agency, the use of CBD raises safety concerns, especially with long-term use.

The European Medicines Agency has published for public consultation a Good Practice Guide for the use of the Metadata Catalogue of Real-World-Data Sources. The guide provides recommendations on how to use the real-world metadata catalogue that is currently being built and will help to identify suitable RWD sources.

An increasing number of companies with no previous GMP experience are entering the pharmaceutical sector to cultivate, process and manufacture medical cannabis products. Therefore, the MHRA recently posted how the required licences are granted by the agency.

The European Commission (EC) amended the current requirements provided in the Clinical Trials Regulation (CTR) for the labelling of investigational medicinal products (IMPs) regarding expiry dates by means of a Delegated Regulation.

Now that the ICH Q 12 Guideline on Pharmaceutical Product Life Cycle Management has also been implemented in the US, guidance on the subject is following. In a new guideline "Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA", combination products are also addressed.

The "Questions & Answers (Q&A)" documents relating to centralised marketing authorisation procedures, last revised in June, have now been updated again and published on the European Medicines Agency (EMA) website. These Q&As are intended to provide guidance and guidelines for marketing authorisation holders and applicants of centralised procedures and to provide answers to potential questions at different stages of the centralised marketing authorisation application process.

The analysis of the Warning Letters sent out in fiscal year 2022 offers a revealing overview of what FDA inspectors find when they visit the production facilities of medicinal product manufacturers. Read more about the "Top Ten" GMP violations.

The latest version (version 16) of the "How to do" document - Interpretation of ICH Q7 Guide and "Review form" for active pharmaceutical ingredients was finalised in July 2022 and published on the new APIC (Active Pharmaceutical Ingredients Committee) website at the end of October. The document further on aims to facilitate the implementation of the ICH Q7 Guideline and provides recommendations on how to interpret it.

The U.S. Food and Drug Administration (FDA) has issued Warning Letters to Amazon and Walmart. Laboratory analyses showed that both companies sold products that contained diclofenac, which was not listed on the product labels. The FDA sees this as a potential health risk for consumers.