[Stability Testing related News – vol.54]

◆  Adoption and Entry into Force of PIC/S Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1) (1-Jul-21 PIC/S)

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The draft guidance was first published by PIC/S in 2016 and applied by PIC/S Participating Authorities on a trial basis.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”.

◆ Finally published: Reflection Paper on GMP and Marketing Authorisation Holders (4-Aug-21 ECA)

In January 2020, the European Medicines Agency (EMA) published a draft of a so-called reflection paper entitled “Good Manufacturing Practice and the Marketing Authorisation Holder” and invited comments from stakeholders.
Now the final document has been published. The content of the document is GMP responsibilities that apply to Marketing Authorisation Holders. As not all Marketing Authorisation Holders (MAH) are also manufacturers and have a Manufacturing/ Import Authorisation (Manufacturing/ Import Authorisation Holder, MIAH), the aim here is to provide clarity on the different responsibilities and their practical significance for MAHs. Ultimately, the aim was to summarise and, if necessary, explain in one document the responsibilities that are described in various places in the relevant GMP documents such as the EU-GMP Guidelines or the respective Directives.

MAH and MIAH
It is important to note that the title of the reflection paper is “GMP and Marketing Authorisation Holder”, not “GMP for the Marketing Authorisation Holder”.  So far, EU legislation does not require demonstrable GMP competence for pure MAHs. However, the reflection paper describes several GMP responsibilities of the MAH.  Since the MAH has the ultimate responsibility for the product, the MAH should consequently also be responsible for GMP compliance. The MAH is therefore obliged to appoint at least one MIAH with appropriate authorisation and competence.  While many MAHs are also MIAHs with proven GMP competence, many MIAHs are little more than a registered office somewhere in the EU without any manufacturing activities.

What is a reflection paper?
Documents published by EMA fall into a number of defined categories depending on their intended purpose. The following is extracted from the Procedure for European Union Guidelines and Related Documents within the Pharmaceutical Legislative Framework, published by EMA 18 March 2009:
“A reflection paper may be developed to communicate the current status of discussions or to invite comment on a selected area of medicinal product development or a specific topic. It can provide a framework for discussion or clarification particularly in areas where scientific knowledge is fast evolving or experience is limited. A reflection paper does not provide scientific, technical or regulatory guidance, but may contribute to future development of such guidelines, or related document.”