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, 15 January 2025:
The PIC/S Committee has granted the status of Associated Partner Organisation to the African Union Development Agency - New Partnership for Africa's Development (AUDA-NEPAD).
MoreWith a shared dedication to safeguarding public health and safety, PIC/S and AUDA-NEPAD have decided to establish a cooperation agreement in the field of Good Manufacturing Practice (GMP) standards and quality systems for pharmaceutical products and Active Pharmaceutical Ingredients (API).
The scope of the cooperation agreement includes :
With the active contribution of other stakeholders, collaboration activities will aim at supporting capacity and confidence building among African NRA and at guiding them on their journey toward becoming PIC/S Participating Authorities.
The agreement is also a great opportunity for both partners to develop exchanges of information and share experiences.
This partnership reflects PIC/S commitment to strengthening global harmonization and cooperation in the field of GMP.
We look forward to working closely with our partners and stakeholders to achieve these goals and foster a more robust regulatory environment worldwide.
An official welcome will be given to AUDA-NEPAD at the next PIC/S Committee meeting, which will take place in Geneva on 14 and 15 April 2025.
Geneva, 8 January 2025:
The Department of Health and the Pharmacy and Poisons Board of Hong Kong are pleased to host the 2025 PIC/S Seminar on “Advanced technologies in pharmaceutical manufacturing” in Hong Kong (Hong Kong SAR, China) from 5-7 November 2025, preceded by the PIC/S Committee meeting.
The Seminar is the main annual international training event by PIC/S which is open to GMP Inspectors from PIC/S Participating Authorities, (Pre-)Applicants, Partners and non-PIC/S Member Medicines Regulatory Authorities.
Geneva, 6 January 2025:
It is with great sadness that we share the news of the passing of our esteemed colleague Boon Meow Hoe.
Boon was an emblematic figure of PIC/S for more than 25 years, occupying various positions in our structure, as Chair of course, but also as a member of the Executive Bureau.
He played a key role in the creation of the PIC/S Inspection Academy (PIA), which he continued to support in his role as Chair of the Subcommittee on Training. His imprint on our family is indelible.
Boon's passing is a terrible loss both on a human and professional level and we can only bow before his memory. We will all remember a smiling, courteous, efficient Man, always ready to find solutions. He gave his all for his country but also for us with a vision that was always present to ensure the development and sustainability of PIC/S. He always worked with the same target of ensuring protection of Public Health.
May he rest in peace and live on in our memories, for ever.
Our deepest condolences to his Family and to the Health Sciences Authority of Singapore (HSA).
Geneva, 13 December 2024:
PIC/S has published the following two guidance documents for inspectors: "Guidance on Remote Assessments" (PI 056-1) and "Aide Memoire on Remote Assessments" (PI 057-1). These documents have been prepared by the PIC/S Working Group on Remote Assessment, led by Jenny Hantzinikolas (Australia / TGA), and will enter into force on 1 January 2025. They are available for downloading on the page "Publications".
Geneva, 20 November 2024:
PIC/S is pleased to announce that in May 2024 it has been awarded a 3-year grant from the Bill & Melinda Gates Foundation.
MoreThis funding will provide PIC/S with the necessary resources to further its mission to improve public health by leading development and implementation of inspection frameworks for human and veterinary medicines through harmonisation of standards and offering world class training to regulatory inspectors around the globe.
The PIC/S project workstreams supported by this grant will aim at strengthening regulatory inspection standards to facilitate improved access to quality medicines in African countries by preparing a number of African National Regulatory Authorities for entry into PIC/S - through the PIC/S pre-accession process - as well as foster exchanges and co-operation between PIC/S, the upcoming African Medicines Agency (AMA) and its related members.
PIC/S looks forward to the possibilities that this grant will bring and to the impact it will have globally thanks to the support of the Bill & Melinda Gates Foundation.