We are pleased to announce on 1. July 2021 that the PIC/S Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1) entered into force. 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The draft guidance was first published by PIC/S in 2016 and applied by PIC/S Participating Authorities on a trial basis.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”.
Direct access to PI 041 final – 1. July 2021