GMP News - Aseptic / Microbiology

In the follow-up to the pandemic situation, the FDA is still reviewing the manufacture and importation of hand sanitizers and identifying potentially critical hand sanitizers. This is shown by the warning letter issued to Guangzhou Orchard Aromatherapy & Skin Care Co.

Almost 1,600 interested colleagues downloaded version 1 of the ECA Expert Task Force's Contamination Control Strategy Guide from the ECA Foundation website - and numerous comments came in. This feedback has now been incorporated into a revised version of the CCS Guide.

At a time of increased interest in mRNA-based medicinal products and vaccines, the USP has published for comment a draft guidance document on "Analytical Methods for the Quality of mRNA Vaccines".

After the revision in 2017, the Monograph 2.6.30. Monocyte Activation Test in the European Pharmacopoeia undergoes a new revision which is open for comments until the end of June.

Without airlocks between cleanroom areas of different cleanroom classes, no flow of material or personnel would be possible. But what are the GMP or purity requirements for airlocks?

The EDQM has launched a survey on whether the test for oxidisable substances for sterilised water for injection (Sterile WFI) in the European Pharmacopoeia should be changed to a test for total organic carbon (TOC). Read more.

In order to support its members, but also to support the industry in general in implementing the requirement of the upcoming revised Annex 1 for a Contamination Control Strategy, the ECA has published a CCS Guideline. This document provides guidance and a template for the development of a contamination control strategy.