GMP News - Analytical Quality Control

A revised chapter 2.1.3. Ultraviolet ray lamps for analytical purposes was published in Pharmeuropa 33.2. Comments on the draft monograph can be submitted until 30 June 2021.

A general revision of Ph. Eur. Chapter 3.2.9 "Rubber Closures" has been proposed in Pharmeuropa 33.2. In particular the proposal includes changes to the sections regarding composition changes and extractable elements, functionality & fragmentation testing.

In the light of the recommendations made in CHMP's final assessment report on nitrosamine impurities in sartan preparations, the European Pharmacopoeia Commission has revised 2 general chapters and 5 API monographs in a rapid procedure. Read more here about which new requirements are specified in the updated sartan monographs.

The USP General Chapters - Physical Analysis Expert Committee revised the general chapter <1912> Measurement of Hardness of Semisolids. Amongst others, a definition for "yield stress" has been added.

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.

Extracts or isolates containing Cannabidiol are used in cosmetics and food supplements supplied to the UK market. One question still remains: How to interprete the 1 mg UK limit for controlled cannabinoids?

The USP Packaging and Distribution Expert Committee intends to revise USP chapter <661.1> Plastic Materials of Construction. The targeted official date is 1 March 2021.