GMP NEWS 2021

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.

When does EU GMP Guide Part II apply to the manufacture of herbal extracts? A new EMA Q&A document on GMP for herbal extracts used as active substances in herbal medicinal products gives the answer to this question.

The Co-ordination Group for Mutual Recognition and Decentralised procedures - Human (CMDh) of the HMA has updated a recently published Guideline on Brexit.

The "Q&A" document for centralised marketing authorisation procedures, focusing on questions and answers on topics that marketing authorisation holders should consider after obtaining a marketing authorisation, was revised again and published on the EMA website in February.

The EMA is still planning with January 2022 as the date for the first application of the Clinical Trial Regulation (CTR). Initial information on the schedule was published in December.

What are the FDA's plans regarding new guidances for the calendar year 2021? An answer to this question is provided by the Center for Drug Evaluation and Research (CDER) in their list of planned and / or to be revised guidance documents. On five pages, comprising 18 individual categories, these documents are presented.

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.