This final article looks at the new requirements in section 10 on Quality Control. It is also a useful point at which to reflect on the 2022 version of annex and what might it mean.

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.

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.

This is the second part of the article covering section 8 of Annex 1 2022 and here we are looking at the requirements around Form fill seal and Blow fill seal.

This next article in our series is about section 8, which is the largest section of Annex 1 and covers production and specific technologies

In this article, we move onto the personnel section, section 7.

In this article we look at the general requirements for the equipment used in the manufacturing of sterile products.

This article explores Annex 1 Section 3, the Pharmaceutical Quality System highlighting requirements beyond those in EU GMP chapter 1.

In the last article, I discussed the scope of the latest update to Annex 1. In this article I want to focus on section 2, “Principle”.