Validation Center™

This document for conducting Good Clinical Practice (GCP) inspections refers the reader the PIC/S  document "Guidance on Good Practices for Computerised Systems in Regulated “GXP” Environments", PI-011-3.

The purpose of this document is to provide a framework for conducting Good Clinical Practice (GCP) inspections.  Annex III provides additional guidance for computer system inspections.

In April 2008, the European Commission published a new, draft version of Volume 4, EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Annex 11, Computerised Systems.  The Annex was updated in response to the increased use of computerised systems an

In April 2008, the European Commission published a new, draft version of Volume 4, EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Chapter 4, Documentation.  The draft updates were written to correspond to changes in EU GMP Annex 11, Computerised Systems.  See sections 4.1, 4.3, 4.7, and 4.9 for new requirements for electronic documentation and records.

The Eudralex rules govern medicinal products in the European Union.  This annex to Volume 4, EU Guidelines to Good Manufacturing Practice for Medicianl Products for Human and Veterinary Use, outlines a program of quality risk management.  See section II.4 for potential application of Quality Risk Management for computer systems.

Specific EU requirements for systems, validation, and associated personnel.

GMP for API manufacturers. See sections 2.22.9, 2.23.8, 5.4, 6.12, 12.1, 12.2, 12.3, 12.6, 13.11, and 13.13 for specific computer and validation requirements.

Specific EU requirements for planning, documentation, and execution of validation and qualification activities.

Specific EU requirements for documentation. See sections 4.5, 4.9, 4,26, and 4.28 for specific computer and validation requirements.