Annex 1

Quality Risk Assessment

PIC/S – New Draft Annex 1 – Part 7 of 8

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”. …

Quality Risk Assessment

PIC/S – New Draft Annex 1 – Part 6 of 8

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 …

Quality Risk Assessment

New draft PIC/S Annex 1 – Part 5 of 8

Parts 5 & 6 of the blog series on the draft revision of Annex 1 looks at Chapter 8 (Production & Specific Technologies). The chapter has been separated into two blog posts due to …

Quality Risk Assessment

New Draft PIC/S Annex 1 – Part 4 of 8

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, …