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News about GMP/cGMP

2018-05-14

PIC/S Meeting in April 2018

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

 

The results at a glance:

  • New PIC/S guidance on GMP inspection reliance based on a draft by ICMRA with the aim to maximise inspection resources for GMP compliance of overseas facilities.
  • Revision of PIC/S GMP guide (PE 009).
    Chapters 3, 5 and 8 of the PIC/S GMP guide have been revised and will enter into force on 1 July 2018.
    The revised Chapters 3, 5 & 8 of the PIC/S GMP Guide are based on the equivalent Chapters of the EU GMP Guide with some minor differences in terms of language. These Chapters of the PIC/S GMP Guide have now been aligned with principles of Quality Risk Management. Chapter 3 and 5 have been revised to include requirements to prevent cross-contamination.
    Expectations with regard to quality management system for the evaluation of quality defects in relation to product recalls have been expanded in Chapter 8, which has been entirely revised.
  • New PIC/S working group established with WHO to revise annex 2 on biologicals and ATMP.
    The objective is to advance a recommendation to the PIC/S Committee on a strategy to harmonise where possible with the EC guidelines while addressing the perceived concerns raised by PIC/S Participating Authorities which have led to an international divergence in this field.
  • The PIC/S Working Group on Data Integrity has revised the Draft PIC/S Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments.
    The Committee agreed to a focused stakeholder consultation.
  • New PIC/S aide-memoire on cross-contamination in shared facilities. The document will enter into force on 1 July 2018.
  • The PIC/S Committee adopted the transposition for PIC/S purposes of the following European Commission (EC) guidance documents:
    - Guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use (PI 045-1);
    - Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (PI 046-1);
    - Guidelines on the principles of Good Distribution Practice for active substances for medicinal products for human use (PI 047-1).
    These Guidelines will enter into force on 1 July 2018.
  • Ongoing PIC/S membership applications (e.g. Armenia, Brazil, Italy, Pakistan, Russian Federation, Minpromtorg Russia and FSI, Saudi Arabia)
  • 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.
Source:

PIC/S Press Release

 

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