Geneva, 15 June 2021:
Background
EU GMP Annex 16 on Certification by a Qualified Person* and Batch Release entered into force in 2002. At the time, PIC/S did not deem it necessary to transpose this EU-specific annex for PIC/S purposes. Following the revision of EU Annex 16 in 2016, PIC/S re-discussed whether to transpose Annex 16 in order to harmonise internationally requirements regarding product release in line with PIC/S’ mission “to lead the international development, implementation and maintenance of harmonised GMP standards and quality systems of Inspectorates in the field of medicinal products”. The PIC/S Sub-Committee on GMDP Harmonisation (SCH), led by Paul Gustafson (Health Canada), was mandated to transpose a PIC/S version of EU GMP Annex 16 in accordance with a memorandum of understanding with the European Medicines Agency (EMA).
* The PIC/S term of “Authorised Person” and the EU term of “Qualified Person” are strictly equivalent.
Public consultation
Following several internal rounds of consultation and extensive discussion between PIC/S Members on draft versions of PIC/S Annex 16, the PIC/S Committee recently agreed to proceed to Step 2 of the PIC/S consultation process. Step 2 of the PIC/S adoption process enables an opportunity for PIC/S Participating Authorities to consult with stakeholders. PIC/S Participating Authorities may take differing approaches to consultation. Some may engage in consultation at later periods through local harmonisation efforts that realize subsequent adaptation of PIC/S GMP into jurisdictional specific GMP guides or requirements.
This consultation will be launched on 15 June 2021 for a period of 3 months. The consultation will focus on national stakeholders of non-EU/EEA Members of PIC/S, considering that EU/EEA Members of PIC/S already apply EU Annex 16.
Where the implementation of PIC/S Annex 16 will affect a jurisdiction, the competent PIC/S Participating Authority will consult pharmaceutical industry associations. This consultation may also be open to the general public and other stakeholders. Comments from stakeholders will be considered carefully while working toward a general objective of ensuring continued harmonisation and equivalence between the EU and PIC/S GMP Guides. Minimal deviations between the guides will help work toward improved global harmonisation.
International professional and industry associations, which are interested to contribute to the PIC/S consultation process, are invited to channel their consolidated comments through one of the PIC/S Participating Authorities, which will launch a public consultation. For further enquiries, please contact info@picscheme.org
Geneva, 29 September 2021: On 24 September 2021, China’s National Medical Products Administration (NMPA) submitted an application for “pre-accession” to PIC/S. This is a voluntary but highly recommended assessment step that can be completed prior to submitting an application to become a PIC/S Participating Authority. The Pre-Accession Procedure provides up to 2 years to identify any gaps between PIC/S membership requirements and the system used by the interested Competent Authority. This step helps in understanding of PIC/S’ expectations in terms of membership and compliance to facilitate success in any future membership application under the PIC/S Accession Procedure. You can find more information about the two steps in PIC/S’s Pre-Accession and Accession Procedures on our website. As a next step, the PIC/S Committee will nominate a Rapporteur and one or several Co-Rapporteurs, who will manage and oversee NMPA’s pre-accession process.
Geneva, 2 August 2021: Registrations for the 2021 PIC/S Seminar on "GMP Assessment Approaches in Post COVID-19 Era" which will be hosted virtually from 9-11 November 2021 are now open (for Medicines Regulatory Authorities only). Deadline for registration is 3 October 2021.
For more information, please contact the PIC/S Secretariat.
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The Ministry of Food and Drug Safety (MFDS) of the Republic of Korea is pleased to announce that the 2021 PIC/S Virtual Seminar will be hosted by MFDS from 9 to 11 November 2021.
The Seminar on “GMP Assessment Approaches in Post COVID-19 Era” will consist of presentations, interactive panel discussions, and workshops for GMP Inspectors from around the world.
As the COVID-19 pandemic has put restrictions on GMP on-site inspections, various alternative GMP assessment approaches have been taken by Regulatory Authorities to ensure the quality of pharmaceuticals. As we face the post COVID-19 era, there is a need to explore the current and future status of these GMP assessment approaches. There is also a need to be prepared for the changes that will likely be seen in post COVID-19. Therefore, in this Seminar, we look forward to valuable presentations and discussions regarding different experiences in distant assessment from regulatory and industry experts; and regarding the status of GMP assessment based on reliance.
The Seminar is open to the participation of Inspectors from Medicines Regulatory Authorities around the world.
Geneva, 15 July 2021: PIC/S is pleased to announce that following its adoption by the PIC/S Committee on 30 June 2021, the guidance on “COVID-19 Risk Assessment for Routine On-Site Inspections” (PI 055-1) will enter into force on 15 July 2021. This guidance for inspectorates, which has been prepared by the PIC/S Working Group on Inspectors Safety, is available for downloading on the page “Publications”.
Geneva, 15 July 2021: PIC/S is pleased to announce the coming into force on 15 July 2021 of the PIC/S Recommendation document titled “How to Evaluate and Demonstrate the Effectiveness of the Pharmaceutical Quality System with regard to Risk-Based Change Management”, PI 054-1. This document addresses two fundamental and inter-related elements of the PIC/S GMP Guide - PQS effectiveness and the management of changes. It provides practical guidance for GMP Inspectors in these areas, and the implementation of that guidance has the potential to ultimately lead to the more timely management of risks to product quality and patient safety, as well as better quality and manufacturing performance, continual improvement and innovation. This serves the interest of patients and animals.
In addition to providing guidance for GMP Inspectors, the document provides the pharmaceutical industry with a ready-made solution for addressing a key aspect of ICH Q12 - the requirement to have an effective PQS that can support the risk-based management of post-approval changes when there is more flexible regulatory oversight of such changes in place.
The input of industry representatives was considered during the development of this document and their contributions are gratefully acknowledged.
To download this guidance (PI 054-1), please consult the page “Publications”.
Geneva, 1 July 2021: PIC/S is pleased to announce that following adoption by the Committee on 1 June 2021, the PIC/S Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1) will enter into force on 1 July 2021. The document marks the completion of significant effort by PIC/S Participating Authorities over an extended period of collaboration to address an area of significant industry and regulatory interest. The guidance has been developed primarily for inspectors, but also serves as a valuable resource for industry to provide clarity on areas of greatest risk and regulatory expectations. The PIC/S Working Group on Data Integrity acknowledges the support from professional associations across the pharmaceutical industry who contributed to a targeted stakeholder engagement exercise in 2019. The feedback received was highly valuable in identifying opportunities to further clarify regulatory interpretations and also collate topics for future revisions.
The draft guidance was first published by PIC/S in 2016 and applied by PIC/S Participating Authorities on a trial basis. Based on Members’ comments, it was revised by the Working Group on Data Integrity and then subject to a focused stakeholder consultation on specific issues (November 2018 – March 2019). The Working Group incorporated the feedback from stakeholders and submitted the final draft to the PIC/S Committee for adoption.
The Working Group continues its data integrity activities through development of training material for the PIC/S Inspectorates’ Academy (PIA) and other inspection-related resources for inspectors within the network.
To download this guidance (PI 041-1), please consult the page “Publications”.