News

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”. 

January 2024

6th PIC/S Expert Circle Meeting on Good Distribution Practice (GDP)

Geneva, 30 January 2024:

The Department of Health and the Pharmacy and Poisons Board of Hong Kong (PPBHK) hosted the 6th PIC/S Expert Circle Meeting on Good Distribution Practice (GDP) from 29 November to 1 December 2023 via Zoom. A total of 230 participants joined the meeting. The meeting included discussions on contemporary issues and latest developments in the field of GDP and supply chain integrity; consolidating lessons learnt during COVID to support uninterrupted supply chain of medicine; sharing experiences between inspectors to improve consistency among inspectors in the field of GDP; and exchanging ideas and fostering collaboration among inspectorates. Follow us on LinkedIn.

January 2024

PIC/S-EMA-WHO Joint Implementation Working Group on Revised Annex 1 (manufacture of sterile medicinal products)

Geneva, 23 January 2024:

Friday, 19 January marked the inaugural kickoff meeting of the PIC/S-EMA-WHO Joint Implementation Working Group, bringing together experts from WHO, EMA, and PIC/S Participating Authorities. The goal is to achieve harmonized interpretation of the newly released PIC/S-EU GMP Annex 1 on Sterile Manufacturing. Follow us on LinkedIn.

January 2024

2024 Wishes and Video Message from New PIC/S Chairperson, Mr Jacques Morénas

Geneva, 15 January 2024:

The new PIC/S Chairperson for the period 2024-2025, Mr Jacques Morénas (France / ANSM), is pleased to share with you his 2024 greetings and best wishes in the following video message highlighting key PIC/S priorities and activities for the year coming.

November 2023

PIC/S Committee Meeting and Executive Bureau in Bangkok (Thailand)

The Thailand Food and Drug Administration (Thai FDA), Ministry of Public Health, hosted the following PIC/S events in Bangkok (Thailand) on 6-10 November 2023: PIC/S Committee Meeting, PIC/S Executive Bureau Meeting and PIC/S Annual Seminar.

The PIC/S Committee met on 6-7 November 2023, under the chairmanship of Mr Paul Gustafson (Health Canada). The meeting was attended by 37 out of 56 PIC/S Participating Authorities (PA) as well as by a number of Applicants, Pre-Applicants, and Associated Partner Organisations. 

 

November 2023

Co-operation with ICH

Geneva, 29 November 2023:

The PIC/S Committee welcomed at its meeting in Bangkok on 6-7 November 2023 the signature of a Memorandum of Understanding (MoU) between PIC/S and ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) in October 2023.

Both parties are engaged in pharmaceutical harmonisation activities, PIC/S being an Observer in ICH since 2017 and many Regulatory Members in ICH are also “Participating Authorities” in PIC/S. This MoU is intended to facilitate collaboration on a number of ICH Guidelines that are relevant also for Inspectorate activities and provide training for both assessors and Inspectors.

The MoU lays down the basis for future co-operation between PIC/S and ICH further to the expiry of the ICH pilot on “More Routine Engagement of ICH with PIC/S on ICH Q Guidelines that involve Inspectorates in Implementation”. It provides a framework for co-operation on training efforts, which PIC/S looks forward to strenghtening with ICH.