GMP NEWS 2020

The European Commission has published an aide memoire for Good Distribution Practices (GDP) inspection of wholesalers’ compliance with Commission Delegated Regulation (EU) 2016/161 for safety features.

After long discussions, EMA has published a Reflection Paper on Good Manufacturing Practice and Marketing Authorisation Holders summarizing various MAH GMP-responsibilities.

A US-American pharmaceutical manufacturer received a Warning Letter from the FDA in November 2019 due to microbial issues in the water system, deficiencies in qualification/validation and insufficient stability data. Read more here.

The FDA issued a Q&A document correlated to the final rule on Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use.

Stability testing of drug products is required by 21 CFR 211.166 of the cGMP guidelines. There has been an increase in GMP violations related to stability testing. A few days ago, a German company received an FDA Warning Letter in which, among others, the stability program was criticized.

The US Food & Drug Administration (FDA) recently sent a Warning Letter to a US pharmaceutical company criticising batch record design and review and quality oversight.

Anyone who has gradually lost track of the mass of information about nitrosamine impurities can now consult the EDQM website. Read more about where to find important documents, e.g. analytical methods of determination on the new EDQM website for nitrosamines.

The FDA issued a Warning Letter due to non-compliance with cGMP, including Data Integrity and Validation issues, to a Canadian manufacturer of over-the-counter drug products.

Four of five Warning Letters recently published broached the issue of handling deviations and inadequate CAPA.