Geneva, 20 June 2018:
The following new PIC/S Guidance documents have been adopted:
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).
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”
Geneva, 30 July 2026
PIC/S has published the revised PIC/S Recommendations on Qualification and Validation (PI 006-4).
These Recommendations have been revised by a dedicated PIC/S Working Group, successively chaired by Norman Gray (UK / MHRA) and subsequently jointly chaired by Kevin O’Donnell (Ireland / HPRA) and Rebecca Dowd (USA / US FDA). They supersede the PIC/S Recommendations on Validation Master Plan; Installation and Operational Qualification; Non-Sterile Process Validation; and Cleaning Validation (PI 006-3).
PI 006-4 will enter into force on 1 October 2026.
To download the revised Recommendations document, please consult the page “Publications”.
Geneva, 28 July 2026:
Registrations for the 2026 PIC/S Seminar on “Digital Transformation in GMP” which will be hosted by Türkiye / TMMDA from 4-6 November 2026 are now open (for Medicines Regulatory Authorities only). Deadline for registrations is 31 August 2026 (early-bird) and 23 October 2026 (standard).
For more information, please contact the PIC/S Secretariat.
Geneva, 28 July 2026:
On 15 July 2026, a Rapporteur was appointed by written procedure for the pre-accession application of Emirates Drug Establishment (EDE), for which a pre-accession application was received on 5 March 2026.
In line with the revised PIC/S Guidelines for the Pre-Accession Procedure, the designation of the Rapporteur marks the start of the pre-accession process.
Geneva, 28 July 2026:
On 17 December 2025, the State Entity “Center of Good Practices” of the Pharmaceutical Industry Development Agency under the Ministry of Health of the Republic of Uzbekistan and the State Institution “Center for Pharmaceutical Products Safety” under the Ministry of Health of the Republic of Uzbekistan, submitted a joint membership application to PIC/S.
The application received was completed on 15 January 2026, further to which the Rapporteurs and Audit Team are in the process of being appointed by written procedure.
Geneva, 16 July 2026:
The joint EMA - PIC/S drafting group has developed a concept paper on the revision of the Annex 15 (Qualification and validation) of the EU - PIC/S GMP Guide.
This concept paper aims to outline the rationale, objectives, and proposed changes for updating the Annex 15 - Qualification and validation, of the Good Manufacturing Practice (GMP) Guide, that is common to the Member States of the European Union (EU) / European Economic Area (EEA), as well as to the Participating Authorities (PAs) of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The aim of the revision is to extend the scope of the annex to active substances manufacturers and to consider the revision of ICH Guideline Q9 (R1) on quality risk management.
This concept paper was submitted to a joint EMA - PIC/S public consultation and comments have been collected until 9 April 2026. Following the public consultation, the initial timetable has been revised, and only this section has been updated accordingly.
The revised Concept Paper can be downloaded on the PIC/S website (link), as well as on the EMA website (link).