Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments

On 1 July 2021 the PIC/S Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1) entered into force.

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 The draft guidance was first published by PIC/S in 2016 and applied by PIC/S Participating Authorities on a trial basis.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 guidance has been written to apply to on-site inspections of those sites performing manufacturing (GMP) and distribution (GDP) activities. The principles within this guide are applicable for all stages throughout the product lifecycle. The guide should be considered as a non-exhaustive list of areas to be considered during inspection.

The guidance also applies to remote (desktop) inspections of sites performing manufacturing (GMP) and distribution (GDP) activities, although this will be limited to an assessment of data governance systems. On-site assessment is normally required for data verification and evidence of operational compliance with procedures.

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