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Final GMP data integrity guidance– PIC/S

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) announced that its new guidance on good practices for data management and integrity for pharmaceutical manufacturers and distributors is finalized and it is in effect.

Data management refers to all those activities performed during the handling of data including but not limited to data policy, documentation, quality, and security.

Data Integrity is defined as “the degree to which data are complete, consistent, accurate, trustworthy, and reliable and that these characteristics of the data are maintained throughout the data life cycle”.

This document was written with the aim of providing guidance for Inspectorates in the interpretation of GMP/GDP requirements in relation to good data management and the conduct of inspections.

The final guidance document runs to 63 pages and this guide is not mandatory or enforceable under law.

It is not intended to be restrictive or to replace national legislation regarding data integrity requirements for manufacturers and distributors of medicinal products and actives substances (i.e. active pharmaceutical ingredients). Data integrity deficiencies should be referenced to national legislation or relevant paragraphs of the PIC/S GMP or GDP guidance.

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