GMP News

In the Pharmacopeial Forum, PF 48(6), a proposal for a revised Chapter <711> Dissolution was published. The purpose of the revision is to replace USP Prednisone Tablets RS with a new Reference Standard, USP Dissolution Performance Verification Standard-Prednisone RS, to qualify the Dissolution Apparatus 1 and Apparatus 2.

The current EU GMP Annex 11 "Computerised Systems" was published in 2011. Due to new technological and regulatory developments, a forthcoming revision of Annex 11 has been discussed for some time. On 16 November 2022, the EMA published a concept paper for public comment. Which points are to be revised?

The agency is conducting an Advancing Real-World Evidence Program, which seeks to improve the quality and acceptability of RWE-based approaches in support of new intended labeling claims.

Some authorities within the PIC/S want to mutually recognise GMP inspection reports in order to avoid duplication of work. There is now a corresponding statement on this.

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.

End of October 2022, the Competent Authority of Belgium (Federal Agency for Medicines and Health Products) added a new GDP Non-Compliance Report to the EudraGMDP database. The authority blames the company in question for a whole series of GDP violations.

Financial and organizational advantages also speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 1: What is the meaning of IaaS / PaaS / SaaS / XaaS?

The EMA published the ICH M11 draft Guideline on the Clinical Electronic Structured Harmonized Protocol (CeSHarP) for comments. The comment period runs until February 26, 2023.