Geneva, 28 November 2019:
PIC/S has published on a draft basis a Recommendation on How to Evaluate / Demonstrate the Effectiveness of a Pharmaceutical Quality System in relation to Risk-based Change Management (PI 054-1 (Draft 1)) developed by the PIC/S Expert Circle on Quality Risk Management (QRM).
This draft Recommendation will be applied on a 6-month trial basis by PIC/S Participating Authorities.
The purpose of this draft document is to provide guidance on evaluating and demonstrating the effectiveness of a PQS in relation to risk-based change management. This is in recognition of the fact that the PIC/S GMP Guide requires companies to demonstrate the effectiveness of their PQS and to apply quality risk management (QRM) principles to change control activities. Further information on the background to this Recommendation and the anticipated benefits of this guidance are provided in PIC/S Concept Note (PS/INF 88/2019).
This draft document is not open for comments by industry. Formal adoption of the guidance will proceed in accordance with PIC/S procedures on a revised version after completion of the trial-period.
To download the draft Recommendation (PI 054-1 (Draft 1)) and the Concept Note (PS/INF 88/2019), please consult the page “Publications” or click on the links below:
Geneva, 23 September 2026:
The PIC/S GMP Guide to Good Manufacturing Practice (GMP) for Medicinal Products has been revised to include the revised Annex 19 (Reference and Retention Samples).
The revision of PIC/S Annex 19 primarily concerns Section 9, which addresses reference and retention samples for parallel imported, parallel distributed, and parallel traded products. The note clarifying that Section 9 applies only where local legislation covers parallel imported, parallel distributed, or parallel traded products — present in the previous version of the PIC/S GMP Guide (PE 009-17) — has been retained in the current version (PE 009-18).
This update aligns with the Co-operation Agreement between PIC/S and the EMA, which mandates the harmonisation of PIC/S and EU GMP Guides. The aim is to maintain equivalent GMP standards, thereby facilitating the exchange and use of information concerning the manufacture of medicinal products, in line with PIC/S' mission to lead the international development, implementation, and maintenance of harmonised GMP standards and quality systems for inspectorates in the field of medicinal products.
The revised Annex 19 was successfully adopted by the PIC/S Committee by written procedure on 22 September 2026.
The revised GMP Guide (PE 009-18), with the revised Annex 19 will enter into force on 24 September 2026. This coincides with the entry into force of the revised Annex 19 in the EU following the publication by the European Commission of the revised Annex 19 on Eudralex Volume 4 on 23 June 2026.
All non-EEA Participating Authorities of PIC/S and Applicants have been invited to transpose Annex 19 of the PIC/S GMP Guide into their own GMP Guides.
To download the revised GMP Guide (PE 009-18), please consult the “Publications” page.
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.