PIC/S Meeting: What’s new for GMP?
In April 2019, the PIC/S Committee and the PIC/S Executive Bureau met in Geneva, Switzerland. The meeting was attended by 45 out of 52 PIC/S Participating Authorities as well as by a number of Applicants, Pre-Applicants, Associated Partners and Guests. Here are the topics addressed in the area of GMP:
- The PIC/S Guidance on GMP Inspection Reliance (PI 048-1) entered into force in June 2018 and was successfully implemented. With the given voluntary framework, PIC/S members can now rely on each other’s inspection reports or GMP certificates or take informed decisions on the GMP compliance of a manufacturing facility. With 52 Members worldwide, the PIC/S network provides a unique platform for this reliance process, as all Members have an equivalent GMP Regulatory Compliance Programme in place.
- Since 1 January 2019, these efforts are being documented based on a template including metrics. The interest of Industry in PI 048-1 and its implementation is key, as it is up to manufacturers to proactively share reports if they wish to avoid duplicate inspections. The PIC/S Sub-Committee on Strategic Development will be discussing an offer made by ISPE’s Global Pharmaceutical Manufacturing Leadership Forum (GPMLF) to monitor regulatory inspections in connection with the PIC/S GMP Inspection Reliance Initiative. The Committee also discussed the sharing of compliance management information for borderline cases in support of PI 048-1. Such cases involve sharing of information on manufacturers who have a low level of compliance but who have not yet reached a state of non-compliance that requires strong regulatory action.
- Since February 2019, the PIC/S-EMA-WHO Working Group (WG) for the revision of Annex 1 of the EU GMP Guide is chaired by France/ANSM. Following the review of more than 6300 comments, the WG is currently in the process of finalising a revised draft. The document will then be the focus of the next PIC/S Seminar in Japan in November 2019.
- The established PIC/S-WHO-Working Group on the revision of Annex 2 of the PIC/S GMP Guide has drafted a new Annex 2A for Manufacture of Advanced Therapy Medicinal Products (ATMP) for Human Use. This new Annex takes into account the EU Guidelines on ATMP while addressing at the same time concerns of PIC/S PAs, as expressed to the European Commission (EC) during the drafting process of the EU Guidelines. Annex 2B for the Manufacture of Biological Medicinal Substances and Products for Human Use will be the revised version of EU Annex 2 for biologics (excluding ATMPs).
- The feedback received on the 3-month focused stakeholders’ consultation on the draft PIC/S guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1 (Draft 3)) is currently under review.
- Internal guidance documents restriced to PIC/S Members-only, are planned. This includes a PIC/S Aide-Memoire on Inspection of Data Management and Integrity as well as system-specific guidances.
- A new Working Group for the development of a PIC/S Aide Memoire on Tissues and Cellular Therapy Products Inspections was established.
- A draft revision of PIC/S Good Practice Guidelines for Blood Establishments and Hospital Blood Banks (PE 005-4 (Draft 1)) has been prepared. It is based on the European Good Practice Guidelines (GPG) for blood establishments.
- A revision of the PIC/S Guide to Inspections of Source Plasma Establishment and Plasma Warehouses (PI 008-3) is in preparation.
- A draft PIC/S Aide-Memoire on Inspection of Health Based Exposure Limit (HBEL) Assessments and use in Quality Risk Management was advanced by the UK / MHRA Chair of the Expert Circle on Cross-Contamination in Shared Facilities (CCCISF).
- The PIC/S Expert Circle on GDP will finalise the draft PIC/S Aide-Memoire on Inspection of Manufacturers and Wholesale Distributors for Compliance with GDP and a Q&A for the PIC/S GDP Guide.
- Currently a future revision of the PIC Scheme (PICS 1/95 (Rev 5)), which gives PIC/S' legal basis as a non-profit association under Swiss law and governs its organisation and functioning is ongoing. A adoption is planned for the Japan-Meeting in November.
- The PIC/S Committee was updated by the Sub-Committee on Training (SCT) on the current status of a new survey on future training priorities for inspectors.
- Bangladesh (DGDA) applied for PIC/S pre-accession.
- Saudi Arabia (SFDA) completed its pre-accession and is now recommended to apply for PIC/S membership.
- Bilateral meeting took place with China and the ICH.
The next Annual PIC/S Seminar on “Quality Assurance of Sterile Medicinal Products – PIC/S GMP Guide Annex 1”, will take place in Toyama, Japan on 13-15 November 2019.
PIC/S: Minutes of Meeting