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Focused stakeholder consultation on revised draft PIC/S guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments

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 purpose of the guidance is to serve to outline the position an inspector would adopt during the inspection of GDP/GMP facilities and is designed to facilitate a harmonized approach to the inspection, including reporting with regard to data management and integrity. A first draft (PI 041-1 (Draft 2)) was published by PIC/S on a trial basis in August 2016.

Following feedback received from PIC/S Participating Authorities during its 6-month implementation trial-period, the draft of this guidance has been updated and expanded by the Working Group.

PDA is happy to assist with a focused stakeholder consultation on this document seeking substantive comments on specific questions relating to the proportionality, clarity and implementation of the guidance requirements.

The consultation period will last 3 months and run from 30 November 2018 to 28 February 2019.