Geneva, 7 July 2025
In light of the rapid advancement of digital technologies and the implementation of AI systems in pharmaceutical manufacturing, the update of Good Manufacturing Practice (GMP) guidelines is essential to ensure that they continue to provide clear, practical and relevant guidance for manufacturers and competent authorities.
The revision of Chapter 4 (Documentation), Annex 11 (Computerized System) and the introduction of the new Annex 22 (Artificial Intelligence) of the PIC/S and EU GMP Guides have been drafted by the Inspectors’ Working Group of the European Medicines Agency (EMA) and PIC/S in order to maintain global alignment of standards, achieving at the same time assurance for the highest quality.
These 3 documents taken together aim at providing a comprehensive and robust framework that supports the implementation of IT technologies in pharmaceutical manufacturing while safeguarding product quality and patient safety.
These documents are subject to a joint stakeholders’ consultation by the European Commission and PIC/S. The consultation period will run for 3 months, from 7 July 2025 to 7 October 2025.
Why to respond to the Joint Consultation
Revision of Chapter 4 - Documentation
The revised Chapter 4 incorporates changes which highlight the importance of documentation in GMP compliance and support the use of new technologies, hybrid solutions, and new services in the management of documentation. Risk-management principles are now central and integrated within the data governance system to ensure the accuracy, integrity, availability, and legibility of documents across all formats—paper, digital, or hybrid. All documentation, whether in text, image, video, or audio form, must remain complete and readable throughout its lifecycle. The guideline also clarifies the requirements for the management of electronic records, signatures, and data integrity while ensuring consistency with the concurrent revision of Annex 11.
Revision of Annex 11 – Computerised Systems
The revised Annex 11 establishes enhanced requirements for the lifecycle management of computerised systems, mandating that Quality Risk Management principles be comprehensively applied during all steps. The updated provisions reinforce obligations concerning the definition and ongoing maintenance of system requirements and the oversight of suppliers and external service providers. Furthermore, the Annex strengthens controls related to the assurance of data integrity, audit trails, electronic signatures, and system security.
New Annex 22 - Artificial Intelligence
The new annex on Artificial Intelligence establishes requirements for the use of AI and machine learning in the manufacturing of active substances and medicinal products. It sets up requirements for the selection, training, and validation of AI models. Emphasis is made on the definition of the intended use of the model, the establishment of performance metrics, the quality of model training data, and the management and processing of test data. Annex 22 foresees a continuous oversight of AI systems, including change control, model performance monitoring and procedures for human review when necessary.
How to respond to the Joint Consultation
If you wish to participate in this targeted consultation and are a member of a stakeholders’ organisation, please contact your organisation to submit your comments.
If you wish to participate and are not a member of a stakeholders’ organisation, comments must be submitted via the EU Survey tool in accordance with the PIC/S-EMA Harmonised Consultation Procedure.
To download the consultation documents and the template required to submit comments or for any queries in relation to this consultation, please refer to the European Commission website by clicking here.
The consultation documents are also published on the PIC/S website under the section Drafts on the page Publications.
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.