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HDA UK Media And Political Bulletin – 14 March 2017

Media Summary

PIC/S meeting – February 2017
MHRA Inspectorate, Mark Birse, 13 March 2017

The press release from the recent PIC/S Committee and PIC/S Executive Bureau meetings in Geneva has been published. Central to the Pharmaceutical Inspection Co-operation Scheme (PIC/S) – a non-binding agreement between health authorities to improve co-operation in Good Manufacturing Practices (GMP) – is training of GMP inspectors. PIC/S also offers training tools to inspectors active in other areas such as Good Distribution (GDP) and Good Clinical Practices (GCP). Highlights in the latest release include plans to develop the PIC/S Inspectorates’ Academy, which aims to harmonise GMP training at an international level. The full release can be found here.

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PIC/S meeting – February 2017

MHRA Inspectorate, Mark Birse, 13 March 2017

From 8 to 10 February 2017, the PIC/S Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland.

The press release for the meetings has been recently published.

The highlights of the meeting were:

  • New PIC/S strategic plan (road map) for 2017-2019
  • Strong stance taken by PIC/S on European Commission’s proposed stand-alone advanced therapy medicinal products (ATMP) GMP guidelines, which will not only lower GMP standards for ATMP at the risk of patients but lead to international dis-harmonisation
  • New PIC/S application lodged in August 2016 by Italy (vet) / DGSAF
  • Armenia / SCDMTE and Saudi Arabia / SFDA to apply to PIC/S
  • Latest PIC/S developments in the field of GM(D)P harmonisation, in particular data integrity, revision of annex 1, controlling cross-contamination in shared facilities, classification of deficiencies, GDP, …
  • New stage of development planned for PIC/S Inspectorates’ Academy (PIA): webinars to be prioritised
  • New PIC/S working groups established on unique facility identifiers (UFI) and on managing travel safety of inspectors
HDA UK Media And Political Bulletin – 14 March 2017
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