News

June 2021

PIC/S Adapting EU GMP Annex 16 on Authorised Person and Batch Release

Geneva, 15 June 2021:

Background

EU GMP Annex 16 on Certification by a Qualified Person* and Batch Release entered into force in 2002. At the time, PIC/S did not deem it necessary to transpose this EU-specific annex for PIC/S purposes. Following the revision of EU Annex 16 in 2016, PIC/S re-discussed whether to transpose Annex 16 in order to harmonise internationally requirements regarding product release in line with PIC/S’ mission “to lead the international development, implementation and maintenance of harmonised GMP standards and quality systems of Inspectorates in the field of medicinal products”. The PIC/S Sub-Committee on GMDP Harmonisation (SCH), led by Paul Gustafson (Health Canada), was mandated to transpose a PIC/S version of EU GMP Annex 16 in accordance with a memorandum of understanding with the European Medicines Agency (EMA).

* The PIC/S term of “Authorised Person” and the EU term of “Qualified Person” are strictly equivalent.

Public consultation

Following several internal rounds of consultation and extensive discussion between PIC/S Members on draft versions of PIC/S Annex 16, the PIC/S Committee recently agreed to proceed to Step 2 of the PIC/S consultation process.  Step 2 of the PIC/S adoption process enables an opportunity for PIC/S Participating Authorities to consult with stakeholders. PIC/S Participating Authorities may take differing approaches to consultation.  Some may engage in consultation at later periods through local harmonisation efforts that realize subsequent adaptation of PIC/S GMP into jurisdictional specific GMP guides or requirements.

This consultation will be launched on 15 June 2021 for a period of 3 months. The consultation will focus on national stakeholders of non-EU/EEA Members of PIC/S, considering that EU/EEA Members of PIC/S already apply EU Annex 16.

Where the implementation of PIC/S Annex 16 will affect a jurisdiction, the competent PIC/S Participating Authority will consult pharmaceutical industry associations. This consultation may also be open to the general public and other stakeholders. Comments from stakeholders will be considered carefully while working toward a general objective of ensuring continued harmonisation and equivalence between the EU and PIC/S GMP Guides. Minimal deviations between the guides will help work toward improved global harmonisation.

International professional and industry associations, which are interested to contribute to the PIC/S consultation process, are invited to channel their consolidated comments through one of the PIC/S Participating Authorities, which will launch a public consultation. For further enquiries, please contact info@picscheme.org

May 2021

Revision of PIC/S Blood Guidance Documents (PE 005-4 and PI 008-4)

Geneva, 31 May 2021: the following two PIC/S guidance documents have been revised:

  • PE 005-4: PIC/S Good Practice Guidelines for Blood Establishments and Hospital Blood Banks
  • PI 008-4: PIC/S Aide Memoire to Inspections of Blood Establishments and Plasma Warehouses

These guidance documents have been revised by the PIC/S Working Group on Blood Guidance, led by Switzerland / Swissmedic, on the basis of the Good Practice Guidelines (GPG) for Blood Establishments drafted by the European Directorate for the Quality of Medicines & HealthCare of the Council of Europe (EDQM) and the European Commission.

The revised guidance documents enter into force on 1 June 2021.

To download the revised guidance documents, please consult the page “Publications

April 2021

Revision of PIC/S GMP Guide (PE 009-15)

Geneva, 23 April 2021: The PIC/S GMP Guide to Good Manufacturing Practice (GMP) for Medicinal Products has been revised to include a new Annex 2A and 2B:

  • Annex 2A: Manufacture of Advanced Therapy Medicinal Products for Human Use (ATMP); and
  • Annex 2B: Manufacture of Biological Medicinal Substances and Products for Human Use

Annex 2A provides PIC/S GMP requirements for ATMP - it is not a standalone document but it enables reasonable harmonisation with the standalone ATMP Guidelines published by the European Commission.  Annex 2B had very minor revisions and continues to harmonise with the EU Annex 2 for human use biological medicinal substances and products. 

The revision has been successfully completed by the PIC/S Sub-Committee on the Harmonisation of GM(D)P, led by Paul Gustafson (Canada / ROEB), based on the work of the PIC/S Working Group on Annex 2. This Working Group was led by Francesco Cicirello (formerly with Australia / TGA) until May 2020 and then by Christina Meissner (Austria / AGES), who finalised the revision.

The revised GMP Guide (PE 009-15), with the new Annex 2A and 2B, will enter into force on 1 May 2021. All non-EEA Participating Authorities of PIC/S and Applicants have been invited to transpose the revised Chapters of the PIC/S GMP Guide into their own GMP Guides.

To download the revised GMP Guide (PE 009-15), please consult the page “Publications

January 2021

Jordan applies for PIC/S membership

Geneva, 26 January 2021: On 20 January 2020, Jordan Food & Drug Adminstration (JFDA) submitted a complete membership application to PIC/S. 

The Rapporteur(s) will be appointed either by written procedure or at the next PIC/S Committee meeting.

January 2021

Revision of PIC/S Aide Memoires (PI 009-4; 024-3; 028-2; 038-2)

Geneva, 19 January 2021: the following PIC/S guidance documents have been revised:

  • PI 009-4 Aide Memoire on Utilities
  • PI 024-3 Aide Memoires on Biotech
  • PI 028-2 Aide Memoire on Packaging
  • PI 038-2 Aide Memoire on Assessment of QRM Implementation

The revision process consisted in updating the cross-references to the PIC/S GMP Guide. No other changes were made. The revised Aide Memoires enter into force on 1 January 2021.

 To download the revised Aide-Memoires, please consult the page “Publications