PIC/S press release following April 2018 meeting

From 16 to 18 April 2018 the PIC/S Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland.

The minutes of the meeting have been published today by PIC/S

The highlights from the meeting were:

  • New PIC/S guidance on GMP inspection reliance based on draft by ICMRA with aim to maximise inspection resources for GMP compliance of overseas facilities.
  • Revision of PIC/S GMP guide (PE009). Chapters 3, 5 and 8 of the PIC/S GMP guide have been revised with entry into force on 1 July 2018; along with adoption of transposition for pic/s purposes of EU guidances on GMP exicipent risk assessment, exposure limits and GDP for API.
  • New PIC/S working group established with WHO to revise Annex 2 on biologicals and ATMP.
  • Limited stakeholder consultation for draft PIC/S guidance on data integrity
  • New PIC/S aide-memoire on cross-contamination in shared facilities.
  • New PIC/S pre-accession application received from Pakistan / DRAP.
  • New PIC/S working groups to be established on whistle-blowers/confidential informants; quality defects procedures; as well as PIC/S assessment and re-assessment procedures.
  • PIC/S 2018 seminar to be hosted by US FDA in Chicago and other news in the field of training for GM(D)P inspectors.

From a UK MHRA interest, the adoption of new PIC/S guidance on GMP inspection reliance is a great success.  The ICMRA GMP project group was led by MHRA and was one of the original ICMRA projects established.

The MHRA continues to play a very active role in PIC/S, with participation in various working groups, expert circles, accession applications and membership of the Executive Bureau.

PIC/S Executive Bureau 2018-2019 (from left to right): Jacques Morénas (France / ANSM); Mark Birse (UK / MHRA); Susan Laska (US FDA); Paul Gustafson (Canada / RORB); Boon Meow Hoe, PIC/S Chairman (Singapore / HSA); Andreas Krassnigg (Austria / AGES); Anne Hayes, PIC/S Deputy Chairperson (Ireland / HPRA); Ger Jan van Ringen (Netherlands / IGJ); Paul Hargreaves (UK / MHRA).

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1 comment

  1. Comment by Ursula Busse posted on

    Great progress, thanks for sharing.