PIC/S Publishes Data Integrity Guidance

PIC/S has published, on a draft basis, a guidance on Good Practices for Data Management and Integrity in Regulatory GMP/GDP Environments, which was developed by the PIC/S Working Group on Data Integrity. This draft guidance will be applied on a 6-month trial basis by PIC/S Participating Authorities. This draft document results from the need among Inspectorates to have access to harmonized data integrity guidance, considering the impact to public health. The purpose of the trial period is to learn from implementation. PIC/S acknowledges that the guidance requires expanding in some areas; however, the document has value in describing foundational principles which can be enhanced in future revisions.

The draft guidance applies to both on-site and remote (desktop) inspections of sites performing manufacturing (GMP) and distribution (GDP) activities. There are specific sections in the draft targeted to data integrity considerations for paper-based systems, computerized systems, and outsourced activities. Note that this guidance is not an exhaustive list of areas to be considered during inspection.

The draft guidance also discusses reporting and classification of data integrity deficiencies to aid in consistency of deficiencies by regulatory inspectorates. It also includes a section on expectations for responding to significant data integrity issues.

Summary of PIC/S Guidance – Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments
Draft Published August 2016


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