Annex 1

The final part of the blog series looks at Chapter 10 (Quality Control) and the glossary. In addition, we say goodbye to small number of clauses which have been removed between the 2007 and 2017 versions of Annex 1.

Readers …

This chapter contains information which was previously covered under the headings “Clean Room and Clean Air Device Monitoring”, and also clauses 66-69 on Aseptic Process Simulation (APS) which was under the old heading “Processing”. In addition to the 21 …

As noted in Part 5 of the blog series on the draft revision of Annex 1, Parts 5 & 6 look at Chapter 8 (Production & Specific Technologies).
Part 5 focussed on terminal sterilisation of products and related sterilising processes. “PIC/S – …

In Part 4 of the blog series on the draft revision of Annex 1. We look at Annex 1 Chapter 7 (Utilities), which provides guidance unique to supporting process services, such as water, vacuum, steam and compressed gas systems. …

In Part 3 of the blog series on the draft revision of Annex 1, we look at chapters 5 and 6, on the subjects of Premises and Equipment respectively.

Readers may also wish to view the Initial Blog, Part 1 and …

Continuing our blog series into the new draft PIC/S Annex 1 revision, (see part 1 here), part 2 looks at Chapters 3 & 4. As we move into the detailed chapters (chapter 4 and beyond), we will use categorization …

This is part 1 of a series of blogs which will address the draft annex 1 in full. This series will be presented over the next few weeks, with a focus on individual chapters. For a quick overview and …

Finally, nearly 3 years after it was announced, the New Annex 1 for Good Manufacturing Practice (GMP) has been released in draft form. The EU and PIC/S Annex 1 has long been the GMP bible for manufacturers of sterile …