GxP News
PIC/S GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS (effective: July 1st 2021)
![Immagine News](/media/gwoc2zic/cat-7.jpg?anchor=center&mode=crop&width=722&height=442)
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.
Grazie per il tuo feedback!