PIC/S GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS (effective: July 1st 2021)

This document was written with the aim of providing guidance:

- on the interpretation of existing GMP/GDP requirements relating to current industry data management practices and on the conduct of inspections to sites performing manufacturing (GMP) and distribution (GDP) activities;

- on risk-based control strategies which enable the existing requirements for data to be valid, complete and reliable; 

- to ensure the quality of inspections with regards to data integrity expectations; 

The principles of data management and integrity apply equally to paper-based, computerised and hybrid systems.

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