What you need to know about PIC/S GMP Documentation Tips The TGA’s announcement of its intention to adopt PIC/S GMP PE 009-13 as of 31 December 2017 means Australian GMP manufacturers need to review their current document retention schedules and practices to maintain compliance. PharmOut’s leading PIC/S GMP consultants have studied the new guidance and…
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…
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 help you get ready now for the pending change. Following on from the highly successful PIC/S…
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 of the TGA (Therapeutic Goods Administration) here in Australia. Both administer compliance matters in Good…
On 1st of January 2017, revision 13 of the PIC/S Code of GMP for medicinal products (PIC/S PE 009-13) entered into force. Four Chapters of PIC/S PE 009-13 were revised to align with the current EU GMP code and ICH Q10. This was conducted “with some minor differences in terms of language“. The PIC/S website…
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