A revised Draft PIC/S Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1 (Draft 3) has been prepared by the PIC/S Working Group on Data Integrity, co-led by Australia TGA and UK MHRA.
The document is subject to a focused Stakeholder Consultation seeking substantive comments from trade and professional associations on specific questions relating to the proportionality, clarity and implementation of the guidance requirements. In parallel to this stakeholder consultation, the new draft will be applied by PIC/S Participating
Authorities on a trial basis for a new implementation trial period. The consultation period will last 3 months and run from 30 November 2018 to 28 February 2019.
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology