News

June 2018

New PIC/S Guidance Documents (PI 043-1; PI 045-1; PI 046-1; and PI 047-1)

Geneva, 20 June 2018: the following new PIC/S Guidance documents have been adopted:

  • PIC/S Aide-Memoire on “Cross-Contamination in Shared Facilities” (PI 043-1).

The purpose of this Aide-Memoire is to assist GMP inspectors in the assessment of the risks to the product from cross-contamination in shared facilities. This document provides guidance for GMP inspectors to use in preparation for, and performance of, inspections. It promotes a risk-based approach. This new Aide-Memoire has been successfully developed by the PIC/S Working Group on Controlling Cross Contamination in Shared Facilities, led by Graeme McKilligan (UK / MHRA) and the PIC/S Sub-Committee on the Harmonisation of GM(D)P, led by Paul Gustafson (Canada / RORB).

  • PIC/S Guidelines on the formalised risk assessment for ascertaining the appropriate Good Manufacturing Practice for excipients of medicinal products for human use (PI 045-1);
  • PIC/S 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);
  • PIC/S Guidelines on the principles of Good Distribution Practice for active substances for medicinal products for human use (PI 047-1).

These PIC/S Guidelines transpose for PIC/S purposes the corresponding European Commission (EC) guidance documents. This transposition further strengthens harmonisation between PIC/S and the EU. The Guidelines are in essence equivalent with some minor editorial differences. The Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities is also closely linked to revised Chapter 5 of the PIC/S GMP Guide.

The transposition of these Guidelines has been successfully completed by the PIC/S Sub-Committee on the Harmonisation of GM(D)P, led by Paul Gustafson (Canada / RORB).

The new PIC/S Aide-Memoire and PIC/S Guidelines will enter into force on 1 July 2018 and are applicable on a voluntary basis.

To download the PIC/S Aide-Memoire on Cross-Contamination in Shared Facilities (PI 043-1) and the PIC/S Guidelines (PI 045-1); (PI 046-1) and (PI 047-1), please consult the page “Publications

January 2023

Adoption and Entry into force of New GDP Guidance Documents

PIC/S has published the following two guidance documents for GDP inspectors: an ‘Aide-Memoire on the Inspection of Good Distribution Practice for Medicinal Products in the Supply Chain’ (PI 044-1) and a ‘Questions & Answers (Q&A) document regarding the PIC/S GDP Guide’ (PS/INF 22/2017). These documents have been prepared by the PIC/S Expert Circle on GDP, led by Karen Ford (South Africa / SAHPRA), and will enter into force on 1 February 2023. They are available for downloading on the page “Publications”.

November 2022

Concept Paper on the revision of EU-PIC/S GMP Annex 11 (Computerised Systems)

Geneva, 17 November 2022:  A dedicated European Medicines Agency (EMA) Drafting Group, in which PIC/S is represented by Ib Alstrup (Denmark / DKMA), who is also the Chair of the PIC/S Working Group on the revision of PI 011 (PIC/S Recommendation on Computerised Systems), has developed a concept paper on the revision of Annex 11 (computerised systems) of the EU-PIC/S GMP Guide.

This concept paper is submitted to a joint PIC/S-EMA public consultation from 16 November 2022 until 16 January 2023 and can be downloaded on the PIC/S website (https://picscheme.org/en/publications?tri=date#zone ) as well as on the EMA website (https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/gmp-gdp-inspectors-working-group#concept-papers,-reflection-papers-and-draft-guidelines-section )

Comments should be sent to ADM-GMDP@ema.europa.eu using the EMA template downloadable via the link provided in the Concept Paper by 16 January 2023.

October 2022

PIC/S 50th Anniversary

Geneva, 14 October 2022: The Pharmaceutical Inspection Co-operation Scheme (PIC/S) celebrated its 50th anniversary at a special symposium in Dublin (Ireland) on 4 October 2022. Since the first meeting of the PIC Committee in 1972, PIC/S has come a long way! The symposium titled “Thriving at 50 and Striving Forward” aimed at promoting and highlighting PIC/S’ contributions to international collaboration and co-operation while being resolutely turned towards the future.

The symposium was opened by Ireland’s Health Products Regulatory Authority (HPRA) Chief Executive, Ms Lorraine Nolan, who was hosting. The PIC/S Chairperson, Mr Paul Gustafson (Health Canada) presented on PIC/S new strategic plan for 2023-2027 while the PIC/S Deputy Chairperson, Ms Susan Laska (US FDA), outlined the evolution of pharma industry and PIC/S. The keynote speaker, Ms. Emer Cooke, Executive Director of the European Medicines Agency (EMA), addressed how to strive for better international relationships and collaboration. The programme comprised a wide range of presentations and panel discussions on inspection-related topics, which included participation from Heads of Medicines Agencies, Heads of GMDP Inspectorates and official PIC/S representatives.

Close to 200 participants from all continents participated in the event, including most of PIC/S 54 Participating Authorities and 7 (Pre-)Applicant Authorities, PIC/S Associated Partner Organisations (European Commission, EDQM, EMA, UNICEF, WHO and WOAH) as well as a number of non-PIC/S Competent Authorities. The anniversary also provided a unique opportunity to meet and engage with a range of invited stakeholders present for the occasion and to reconnect with the wider PIC/S network. A more detailed press release will follow covering also PIC/S meetings and 2022 Annual Training Seminar, which took place in Dublin back-to-back with the anniversary symposium.

> To the new PIC/S Strategic Plan (2023-2027)

> To the Anniversary Programme

> To the Anniversary Group Photo

> To the Anniversary Promotional Video

September 2022

The European Commission (DG SANTE) becomes a new PIC/S Associated Partner Organisation

Geneva, 29 September 2022: The PIC/S Committee has granted the status of Associated Partner Organisation to the European Commission’s Directorate-General for Health and Food Safety (DG SANTE).

Recognising that they share a common goal to protect public and animal Health and Safety, PIC/S and DG SANTE have agreed to enter into a working arrangement to co-operate in areas of common interest. The co-operation will notably be on Good Manufacturing and Distribution Practice (GMDP) standards and their implementation processes for medicinal products for human or veterinary use with a view to make best use of available resources and avoid duplication of activities. DG SANTE has very close relations and interactions as part of the EU Regulatory Network with the European Medicines Agency (EMA), which has its own co-operation agreement with PIC/S. Also the Heads of Medicines Agencies of the European Economic Area (HMA) have signed a letter of agreement with PIC/S in 2016. The co-operation between PIC/S and DG SANTE under this new arrangement will be complementary to those co-operations.

This new bilateral co-operation arrangement will lead to opportunities for increased international co-operation and is very much in line with similar agreements that PIC/S has signed with other associated partners such as EMA, EDQM, UNICEF, WOAH and WHO. Along with this new co-operation arrangement, a new trilateral working arrangement on the exchange of non-public information between PIC/S, EC and EMA has also been signed.

An official welcome will be given to DG SANTE at the next PIC/S Committee meeting in Dublin (Ireland) on 3 October 2022.

September 2022

Publication of revised PIC/S Annex 1

The revised Annex 1 to the PIC/S GMP Guide on the manufacture of sterile products has been published and will enter into force on 25 August 2023, except for point 8.123 which is postponed until 25 August 2024. The date of entry into operation is aligned with that of the revised EU Annex 1, which is identical to PIC/S Annex 1 (with some very minor editorial differences).

The entry into force closes a long revision process, which has been driven jointly by PIC/S and the EMA Inspectors’ Working Group (IWG) on GMDP in close co-operation with the European Commission (EC) and the World Health Organization (WHO). This has been a best-in-class model of international co-operation between EC, EMA, WHO, and PIC/S.

Annex 1 was first published in 1971 based on a PIC/S recommendation to ensure the sterility of medicinal products for the benefits of patients. It has undergone a number of partial revisions since its publication. This is, however, the first full revision aiming at restructuring this Annex, adding clarity to the requirements on the sterile manufacturing of medicinal products and introducing the principles of Quality Risk Management to allow for the inclusion of new technologies and innovative processes.

PIC/S decided to establish a Working Group on Annex 1 at its Rome meeting on 15-16 May 2014. It was then merged with the EMA IWG Drafting Group with a view to jointly revise Annex 1. WHO also decided to join the revision process with a view to align Annex 1 to the WHO GMP Guide. The joint Working Group included representatives of the Competent Authorities of PIC/S and EEA as well as WHO. The Working Group was first chaired by Andrew Hopkins (UK / MHRA) and then by Abdelaali Sarakha (France / ANSM).

Following two written consultations of Competent Authorities, the revision of Annex 1 was submitted to joint public consultation in December 2017. Over 6,300 comments were received during the 3-month consultation and then reviewed by the Working Group in 2018-19. This resulted into a new draft of the revised Annex 1, which was submitted to a second joint consultation from February to July 2020, during which approximately 2,000 comments were received and then reviewed by the Working Group in 2020-21.

The revised Annex 1 was then submitted to adoption to the EMA IWG on GMDP and the PIC/S Committee on 1 March and 29 April 2022, respectively. It has then been published by the EC on Eudralex and by PIC/S on the PIC/S website.