The PIC/S Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1) has entered into force on 1 July 2021. 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. It 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 feedback received by professional associations across the pharmaceutical industry was highly valuable in identifying opportunities to further clarify regulatory interpretations and also collate topics for future revisions.
July 5, 2021