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Comment on PIC/S DI Guidance via PDA

by Rebecca Stauffer, PDA | Jan 02, 2019

A revised draft PIC/S Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments has been prepared by the PIC/S Working Group on Data Integrity, co-led by the Australian Therapeutic Goods Administration and UK MHRA.

Providing inspectorates guidance in interpreting GDP/GMP requirements on data management and data integrity, including reporting, is one goal of this document. The guidance will also serve as a tool to facilitate a harmonized approach to inspections and ensure their quality, particularly regarding data integrity expectations.

PIC/S published a first draft of this guidance in August 2016. Following feedback received from PIC/S Participating Authorities during its six-month implementation trial period, the Working Group updated and expanded that draft.

To help develop a focused stakeholder consultation on this document, PDA seeks substantive comments on specific questions relating to the proportionality, clarity and implementation of the guidance requirements.

The consultation period will be open from Nov. 30, 2018, to Feb. 28, 2019. Comments can be sent to PDA’s Vice President of Scientific and Regulatory Affairs Tina Morris using the template found on the PDA website.