Expert View: Annex 1 updates: The impact of microbial ID strategy on cleanroom qualifications for pharma manufacturers
Dr Lucia Ceresa discusses the importance of accurate microbial IDs for cleanroom performance qualification and the risks of inaccuracies or failures.
More than 10 years have passed since the last revision of Annex 1 of the EU good manufacturing practice (GMP) guideline for the manufacture of sterile medicinal products. With the revised document set for release later this year, the updates significantly impact QA/QC and all laboratory activities, more so now than in previous revisions. This update is intended to add detail and clarity and provide global alignment of standards, meaning that even though Annex 1 is a European document, if you are a global drug manufacturer with customers in the EU, you will want to see what is in store for you and your lab.