On 15 July 2011, the EU Commission published this draft guidance, Guideline on Good Distribution Practice of Medicinal Products for Human Use, for public consultation. The deadline for comment is ending on 31 December 2011. This is the first update to GDP directive from 1992.
Please see the following sections for specifics:
This 1992 European Commission guidance, Guideline on Good Distribution Practice of Medicinal Products for Human Use, does not elaborate on any specific requirements for computers or software. However, the 2011 draft update to this document does.
The 2011 draft is also available on the Validation Center site.
This document contains the cumulative directives of the European Parliament and Council from October 1998 through August, 2009 regarding in vitro diagnostic medical devices.
This document contains the cumulative directives of the European Parliament and Council from June 1990 through October, 2007 regarding active implantable medical devices.
This document contains the cumulative directives of the European Parliament and Council from June 1993 through November, 2007 regarding medical devices.
In January 2011, the European Commission published a new version of Volume 4, EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Chapter 4, Documentation. The updates were written to correspond with changes in EU GMP Annex 11, Computerised Systems. This version will go into effect on June 30, 2011.
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, 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 Medicinal 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.
