News

April 2018

2018 PIC/S Seminar (Chicago, USA)

Geneva, 5 April 2018: Registrations for the 2018 PIC/S Seminar on "Management of Risk through the Product Life-Cycle" (Chicago, 26-28 September 2018) are now open (for Medicines Regulatory Authorities only).

The United States Food and Drug Administration (US FDA) is proud to announce that registration is now open for the PIC/S Committee Meeting and Seminar, hosted by US FDA from September 24 -28, 2018 in Chicago, Illinois.

The Seminar, entitled "Management of Risk through the Product Life-Cycle," will consist of interactive discussions, presentations, and workshops.

Risk management is critical to ensuring product quality, safety, and efficacy. The Seminar will explore the best practices impacting risk assessments and share tools and techniques generated from experienced inspectors and assessors to enhance inspections. It will be an ideal opportunity for both novice and experienced inspectors to refine their inspection skills through knowledge sharing and discussion.

For more information: click here 

June 2018

Revision of PIC/S GMP Guide (PE 009-14)

Geneva, 20 June 2018: the following Chapters and Annex of the PIC/S GMP Guide have been revised:

  • Chapter 3 on “Premises and Equipment”;
  • Chapter 5 on “Production”;
  • Chapter 8 on “Complaints and Product Recall”;
  • Annex 17 on “Real Time Release Testing and Parametric Release“.

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. A change in the qualification of suppliers has also been introduced by revised Chapter 5. 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. Revised Annex 17 has been aligned with the EU revision of Annex 17 which will be published shortly by the European Commission (EC).

The revision has been successfully completed by the PIC/S Sub-Committee on the Harmonisation of GM(D)P, led by Paul Gustafson (Canada/RORB). The revised GMP Guide (PE 009-14) will enter into force on 1 July 2018. 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 009-14), please consult the page “Publications

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

June 2018

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

Geneva, 14 June 2017: PIC/S has adopted a new guidance on GMP inspection reliance (PI 048-1), which entered into force on 1 June 2018.

This guidance provides a tool and framework which aims to help Competent Authorities (CA) prioritise resources for GMP inspections for human and veterinary medicines. The main feature of the guidance is that it outlines a process for desk-top assessment of GMP compliance of overseas facilities to identify instances where an acceptable level of GMP compliance can be confirmed and assured from the activities of another CA or CAs without the need for an on-site inspection.

The guidance is based on a draft by the International Coalition of Medicines Regulatory Authorities (ICMRA) GMP Inspection Reliance Framework. It is a non-binding (i.e. applicable on a voluntary basis) high-level guidance for ICMRA and PIC/S Participating Authorities (PA) alike.

For more information see the PIC/S Newsletter of May 2018

To download the guidance, please consult the page “Publications” or click on the link below:

May 2018

PIC/S meetings in Geneva, Switzerland, 16-18 April 2018

Geneva, 9 May 2018: the PIC/S Committee met on 17-18 April 2018 in Geneva (Switzerland), preceded by a meeting of the PIC/S Executive Bureau on 16-17 April 2018.

The press release regarding these meetings is available in newsletter format here or can be downloaded in pdf format from the link below:

December 2017

Joint targeted stakeholders consultation on the revision of Annex 1, on manufacturing of sterile medicinal products, of the PIC/S – EU GMP Guide

Geneva, 20 December 2017: a revision of Annex 1 (Manufacture of Sterile Medicinal Products) of the PIC/S and EU GMP Guides has been prepared in co-operation with the European Medicines Agency (EMA), WHO and PIC/S in order to maintain global alignment of standards, achieving at the same time assurance for the highest quality. The document is subject to parallel public consultation by the European Commission, WHO and PIC/S.

The consultation period will last 3 months and run from 20 December 2017 to 20 March 2018.

Key changes from the earlier Annex 1 are:

  • introduction of new sections: scope, utilities, environmental and process monitoring sections and glossary
  • introduction of the principles of Quality Risk Management (QRM) to allow for the inclusion of new technologies and innovative processes 
  • restructuring to give more logical flow
  • addition of detail to provide further clarity.

In line with the PIC/S-EMA Harmonised Consultation Procedure, comments will be collected by the European Commission (EC). To download the consultation document and the template required to submit comments or for any queries in relation to this public consultation, please refer to the EC website by clicking “here”.

The consultation document is also published on the PIC/S website under the section Drafts on the page “Publications”.