GMP News - Aseptic / Microbiology


PIC/S also publishes revised Annex 1 (Manufacture of Sterile Medicinal Products)

Almost simultaneously with the EU Commission, the PIC/S (Pharmaceutical Inspection Co-operation Scheme) also published the revised Annex 1. What is the background?



Finalised: The revised EU Annex 1 is published

After more than five years and two public drafts for comment, the European Commission this week published the final version of the new EU GMP Annex 1 "Manufacture of Sterile Medicinal Products". Learn more about deadlines and changes compared to the 2nd draft version for comment from 2020.



FDA draws consequences for poor quality of hand disinfectants and UV Wands

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.



Ethanol - an important Active Ingredient for Infection Prevention?

WHO, KRINKO and RKI are concerned with the pending biocide approval and indispensability of ethanol as a component of infection prevention and healthcare. They have published a corresponding statement.



ECA Contamination Control Strategy Guide updated

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.



GMP Deficiencies in the Sterile Area

In a Warning Letter addressed to a US-American pharmaceutical manufacturer, the FDA points out various deficiencies in aseptic production. Among other things, deficiencies are described in the design of equipment and rooms, airflow and visual inspection.



USP publishes Draft Guideline on Analytical Methods for mRNA Vaccines

At a time of increased interest in mRNA-based medicinal products and vaccines, the USP has published for comment a draft guidance document on "Analytical Methods for the Quality of mRNA Vaccines".



USP intends to revise the Chapters on Microbiological Control of Non-sterile Medicinal Products

In PF46(2), the United States Pharmacopoeia has published a Stimuli article addressing the planned revision of chapters relevant to microbiological control of non-sterile products.



PharmEuropa - Revision of Chapter 2.6.30 Monocyte Activation Test

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.



Bioburden - Question and Answers on Biopharmaceutical Manufacturing

Questions - and answers about Bioburden. A first excerpt of the most important questions during the ECA Bioburden Workshop.



What are the GMP Requirements for Airlocks?

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?



Revision of Chapter 2.6.7 of the European Pharmacopoeia published for Comment

After about 10 years, the EDQM has now published a draft revision of Chapter 2.6.7 on mycoplasma testing, which will be available for comment until the end of June.



EDQM Survey: TOC to replace Test for oxidisable Substances in Sterile WFI

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.



ECA comments on FDA Guideline on Visual Inspection

In December 2021, the FDA published its long-awaited Draft Guideline on 100% Visual Inspection of Parenterals. Comments were accepted until mid-February 2022. Members of the Advisory Board of the ECA Visual Inspection Group took advantage of this opportunity and submitted numerous comments.



ECA publishes Contamination Control Strategy Guideline

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.


GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics