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 Part 2 of this series for context. Draft Annex 1 – Chapter 5 – Premises…
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 tables to identify and describe the significance of each change. The categories are: Brand New –…
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 context, you can read our initial blog on the draft here. This first part discusses the draft…
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 medicines, but with more than 10 years now passed since its previous revision, it is fair…
The New PIC/S GMP Version 13 is finally here and it’s all about the people! I have a specific interest in what is in the new PIC/S GMP, for example, Chapter 2 (Personnel), it expands and specifies the responsibilities of all personnel. Let’s look at the New PIC/S GMP together. The introduction to new PIC/S GMP…
Old news I know, and you probably always have done it this way, but did you know with the January 2018 adoption of PIC/S PE009-13 by the TGA, a User Requirement Specification (URS) is now mandatory? Annex 15, §3.1 and 3.2 state that a User Requirement Specification should be a point of reference in the…
New PIC/S GMP version 13 The TGA finally formally announced adoption of the new PIC/S GMP version 13 (PE009-13, 1 January 2017) which is scheduled to commence on 31 December 2017! In this public statement the TGA announced: from 1st January 2018, the TGA GMP inspectors will use the new GMP Guide during inspections. Compliance with the…
In Australia, a Quality Risk Assessment is now a regular GMP activity since we saw the introduction of PIC/S Version PE 009-08, in 2009 (read more here) and the massive impact, especially of the two new clauses §1.5 and §1.6 (Part 1 of the PIC/S GMP) had on the Australian industry, as we followed the USFDA…
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