News

July 2021

Adoption and Entry into force of PI 055-1 "COVID-19 Risk Assessment for Routine On-Site Inspections"

Geneva, 15 July 2021: PIC/S is pleased to announce that following its adoption by the PIC/S Committee on 30 June 2021, the guidance on “COVID-19 Risk Assessment for Routine On-Site Inspections” (PI 055-1) will enter into force on 15 July 2021. This guidance for inspectorates, which has been prepared by the PIC/S Working Group on Inspectors Safety, is available for downloading on the page “Publications”.

July 2021

Entry into Force of PI 054-1 PQS Recommendation

Geneva, 15 July 2021: PIC/S is pleased to announce the coming into force on 15 July 2021 of the PIC/S Recommendation document titled “How to Evaluate and Demonstrate the Effectiveness of the Pharmaceutical Quality System with regard to Risk-Based Change Management”, PI 054-1.  This document addresses two fundamental and inter-related elements of the PIC/S GMP Guide - PQS effectiveness and the management of changes. It provides practical guidance for GMP Inspectors in these areas, and the implementation of that guidance has the potential to ultimately lead to the more timely management of risks to product quality and patient safety, as well as better quality and manufacturing performance, continual improvement and innovation.  This serves the interest of patients and animals.

In addition to providing guidance for GMP Inspectors, the document provides the pharmaceutical industry with a ready-made solution for addressing a key aspect of ICH Q12 - the requirement to have an effective PQS that can support the risk-based management of post-approval changes when there is more flexible regulatory oversight of such changes in place.   

The input of industry representatives was considered during the development of this document and their contributions are gratefully acknowledged. 

To download this guidance (PI 054-1), please consult the page “Publications”. 

July 2021

Adoption and Entry into Force of PIC/S Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1)

Geneva, 1 July 2021: PIC/S is pleased to announce that following adoption by the Committee on 1 June 2021, the PIC/S Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1) will enter into force on 1 July 2021. The document marks the completion of significant effort by PIC/S Participating Authorities over an extended period of collaboration to address an area of significant industry and regulatory interest. The guidance has been developed primarily for inspectors, but also serves as a valuable resource for industry to provide clarity on areas of greatest risk and regulatory expectations. The PIC/S Working Group on Data Integrity acknowledges the support from professional associations across the pharmaceutical industry who contributed to a targeted stakeholder engagement exercise in 2019. The feedback received was highly valuable in identifying opportunities to further clarify regulatory interpretations and also collate topics for future revisions.

The draft guidance was first published by PIC/S in 2016 and applied by PIC/S Participating Authorities on a trial basis. Based on Members’ comments, it was revised by the Working Group on Data Integrity and then subject to a focused stakeholder consultation on specific issues (November 2018 – March 2019). The Working Group incorporated the feedback from stakeholders and submitted the final draft to the PIC/S Committee for adoption.

The Working Group continues its data integrity activities through development of training material for the PIC/S Inspectorates’ Academy (PIA) and other inspection-related resources for inspectors within the network.

To download this guidance (PI 041-1), please consult the page “Publications”.

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