PIC/S Finalizes New Guidance on Data Management and Integrity
The Pharmaceutical Inspection Co-operation Scheme (PIC/S), a non-binding, informal co-operative arrangement between regulatory authorities in the field of good manufacturing practice (GMP) of medicinal products for human or veterinary use, has finalized a new guidance on good practices for data management and integrity, following adoption by the committee on June 1, 2021.
The guidance, PIC/S Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1), has been developed primarily for inspectors, but also serves as a resource for the industry to provide clarity on areas of greatest risk and regulatory expectations.
The draft guidance was first published by PIC/S in 2016 and applied by PIC/S Participating Authorities on a trial basis.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 PIC/S 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.