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News about GMP/cGMP

2018-12-07

PIC/S: Revised Draft Guidance for Data Integrity

On 30 November 2018, the PIC/S has published Draft No 3 of the “Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments” (PI 041-1) for a focused stakeholder consultation.

 

The document is designed to facilitate a harmonised approach to inspection, including reporting in regards to data management and integrity. A first draft 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.

It is now 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.

For more details on how to submit feedback on the draft guidance of PI 041-1, please click here.

Source:

PIC/S: News

 

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