From Jan 1, 2017, the PIC/S GMP guide for Medicinal Products V13 will be in effect. In Australia, the TGA requires version 9 is used, though rumour has it, version 13’s going to be adopted soon. If such proposals as this one, which is mainly concerned with herbal “medicine” from the Complimentary Healthcare Council are ratified, then all future PIC/s updates will automatically apply to Australian manufacture. Something to keep an eye on.
Compliance wise adopting PICS/s 13 over 9 is not too big as deal as the PIC/S guide is based on old ICH Q7A guidelines dating from August 2001 and the right and wrongs do not change much over time unless something major takes place. What manufacturers will need to pay attention to are the changes between version 9 and 13, namely:
- Chapter 1, 2, 4, 6 and 7 revised – Part 1
- Annex 2, 6, 7, 11, 13, 14 and 15 revised
- QRM principles in PIC/S GMP added – Part 2
Based on the contents of V9, things to review:
- Quality Management
- Quality Control
- Contract Manufacturing and analysis
You should already be in control of the above areas as otherwise, you’d be having and uncomfortable 3rd party audit experience. The overall principles do not change, just the fine-print.
Annex 1 deals with the manufacture of sterile medicinal products, so not much impact to us there. If you are performing risk assessments and utilising ISO9001, QRM should already be familiar to you.