GMP News

Many of the requirements laid down in the US-American GMP regulations (21 CFR 210/211) are not very specific. However, they are concretized among other things by Guidances - and by Warning Letters. Warning Letters in particular show very clearly how the FDA interprets its GMP regulations. A current Warning Letter provides information on the tasks of the Quality Assurance Unit.

The U.S. Food and Drug Administration (FDA) pays close attention to what is inside hand sanitizer products imported into the United States. Recently, a product labeled as containing 75% ethanol, but in fact contained only 58%, was detained and refused admission at the border. As a consequence, the Chinese manufacturer received a Warning Letter.

According to the USP no microbiological testing of low water activity pharmaceutical products may be needed after a comprehensive risk assessment. The USP therefore revised the general chapter <1112> Role of Water Activity in Microbial Risk Assessment of Nonsterile Pharmaceutical Products.

The EU demands to reduce animal testing or to avoid it altogether wherever possible. The pyrogen test on rabbits is therefore being replaced by MAT as an alternative in the EU. But how long has this taken and where is the journey going for alternative test systems in microbiology? A short review and outlook can be found here.

In a report published end of January, the U.S. Government Accountability Office (GAO) asks the US Food and Drug Administration (FDA) to review its inspections approach during the pandemic.

With an updated Guidance document, the US Food and Drug Administration (FDA) plans to improve communication with industry.

Pragmatic procedures are currently required to ensure the flexibility needed to maintain the integrity of clinical trials during the COVID-19 pandemic. The updated guidance on management of clinical trials during COVID-19 includes adapted approaches for IMP supply and details on remote source data verification.

Wholesalers must ensure that their Quality Management Systems (QMS) is aligned with the GDP requirements. Otherwise, this can lead to a GDP Non-Compliance Report, as a recent example entered into the EudraGMDP database by the Romanian authority shows.

In October 2020, the ECA Academy offered the Live Online Training "The GDP Compliance Manager". During the Q&A sessions, many interesting questions were posed to the speakers' team. The ECA would like to share a selection of these Q&As sorted by topic. Part 1 deals with questions related to GDP training.

A regular insight and overview of the activities around ATMP in Europe is provided by the reports on the CAT meetings, which list the latest news on classification, authorisation and much more.

Questions reaching us on the subject of COVID-19 vaccines, their development, approval and production, and on modern platform technologies used are answered in a summary.

The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has published an English version of a Procedure for Remote Inspections.