Annex 1 2022 Section 9: Environmental and Process Monitoring
This article is covering section 9 which describes the annex 1 guidance for Environmental and Process Monitoring. Section 9 is now a centralized location for monitoring activities which includes microbiological, particulate and media fills. If we start with...
Annex 1 2022 Section 8: Production and Specific Technologies – part 3
In this final part of the article on section 8 we will look at Sterilization processes. The selection of a sterilization process should be based on scientific principles and validated to demonstrate repeatability and reliability. There are various sterilization...
Annex 1 2022 Section 8: Production and Specific Technologies – part 2
This is the second part of the article covering section 8 and here we are looking at the requirements around Form fill seal and Blow fill seal. The 2008 Annex introduced the concept of blow fill seal in a limited way. It was two clauses under the clean room and clean...
Annex 1 2022 Section 8: Production and Specific Technologies – part 1
This next article in our series is about section 8, which is the largest section of Annex 1. As such, I intend to review it in 3 parts with this article focused mainly on the processes and part two covering Blow and Form fill Seal and the last part of section 8...
Annex 1 2022 Section 7: Personnel
In this article, we move onto the personnel section, section 7. The section starts with reminding us about having sufficient trained and experienced personnel but with the focus on manufacture and testing of sterile products, and any of the specific manufacturing...
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