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
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Pharmaceutical Microbiology