PIC/S – New Draft Annex 1 – Part 3 of 8
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 …
New Draft PIC/S Annex 1 – Part 2 of 8
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 …
New draft PIC/S Annex 1 – Part 1 of 8
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 …
New Draft Annex 1 – PIC/S and EU finally arrives
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 …
New PIC/S GMP PE009-13
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 …
A User Requirement Specification (URS) now mandatory in Australian GMP says PIC/S v13
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 …
Australia finally adopts new PIC/S GMP version 13 – comes into force 31st December 2017
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 …
Quality Risk Assessment
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 …
PIC/S Version 13 is here, are you ready?
For Australian and New Zealand Manufacturers PIC/S Version 13 is due this year, aside from significant changes in Part 1, there are also significant changes in Annex 11, Computers Systems and Annex 15, Qualification and Validation. We plan to …
2015 MHRA GMP Inspection Deficiency Data Trends
The Medicines and Healthcare Products Regulatory Agency (MHRA) is an executive agency of the Department of Health in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe.
It is the equivalent …