Introduction For anyone involved in the manufacturing of sterile medicinal products, the recent PIC/S GMP version 17 Annex 1 guidelines are nothing short of a bible. They delineate the rigorous standards necessary to maintain product sterility. One such crucial aspect outlined in these guidelines is cleanroom monitoring. In this blog, we aim to elucidate the…
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 may also wish to view the Initial Blog, Part 1, Part 2,Part 3, Part 4, Part…
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 clauses from 2007 that have been revised and reallocated to 22 new clauses, there are 27…
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 – New Draft Annex 1 – Part 6 of 8” looks at the remainder of Chapter…
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 size, as it is by far the longest chapter in the draft Annex. At 123 clauses, Chapter 8 represents about 46%…
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