News from the PIC/S

The Pharmaceutical Inspection Convention/Cooperation Scheme (PIC/S) has published a press release about the PIC/S's meetings held in Ukraine from 30 September to 5 October 2012. What's new in the PIC/S?

New Zealand and Taiwan will become new members as from 1 January 2013. Uganda and Belarus have also expressed their interest in a PIC/S membership. Dr Manuel Ibarra - from the Spanish authority (AEMPS) - is the new Liaison Officer with the EU and EMA.

The PIC/S has developed a threefold PIC/S International API Inspector Training Programme in response to the urgent need for inspectors entitled to audit API suppliers:

  • Q7 training, focused on familiarisation with ICH Q7, for industry and regulators;
  • Q&A on ICH Q7 on the interpretation of the requirements of ICH Q7, for industry and regulators;
  • advanced training on API inspection, focusing on improving the skills and sharing approaches for addressing contemporary issues, for regulators only.

Future training activities will address the topics blood, tissues and cells" (expert circle), rapid microbiological methods (training course) and quality risk management (expert circle).

Moreover, the PIC/S audit checklist for APIs and the template for PIC/S audit reports have been revised. The PIC/S has identified new issues on biosafety and biosecurity, veterinary as well as medical devices. These issues should be addressed with "Concept Notes" and set up expert circles.

The Latvian and Lithuanian authorities have been successfully re-assessed by the PIC/S. Besides, the press release informs about the evaluation reports of the new candidate authorities from Brazil, Iran, Japan, Korea, Philippines and United Kingdom's Veterinary Medicines Directorate (VMD). The Chinese SFDA could become one of the next candidate authority. The PIC/S meeting was also the occasion to present information about other PIC/S members (like for example reorganisation of the French authority) and about further associated partners (EDQM, EMA, UNICEF, WHO).

The First Deputy Chairperson of the PIC/S Committee on Training gave a presentation about the current activities. It is particularly interesting to note the planning of a seminar taking place in October 2013 in Canada about "Global Supply Chains and GMP Compliance". Furthermore, an expert circle on Good Distribution Practices (GDP) should be created.

In the future, harmonisation between the EU and PIC/S guidelines should be improved. A respective procedure was signed between the EMA and the PIC/S. Non-EU countries - which are PIC/S members though - should be better involved. At the moment, the Canadian authority and the US FDA are involved in the planned revisions of Annex 15 (on Qualification and Validation) and Annex 17 (on Parametric Release). Based on the revisions of the EU GMP guide, the PIC/S also adopted the following revisions of its guide:

  • Chapter 4 (Documentation)
  • Annex 6 (Medicinal Gases)
  • Annex 7 (Herbals)
  • Annex 13 (Investigational Medicinal Products)
  • Annex 11 (Computerised Systems).

The following revisions were discussed: Annex 2 (Biologicals), Annex 3 (Radiopharmaceuticals) and Annex 14 (Blood and Plasma).
Eventually, the meeting was the occasion for inspectors to discuss new approaches on qualification and validation (i.e. on PAT, RTRT, QRM).

More details can be found in the press release.

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