计算机系统附录11,附录11-计算机系统.pdf

EUROPEAN COMMISSION

HEALTH AND CONSUMERS DIRECTORATE-GENERAL

Public Health and Risk Assessment

Pharmaceuticals

Brussels,

SANCO/C8/AM/sl/ares(2010)1064599

EudraLex

The Rules Governing Medicinal Products in the European Union

Volume 4

Good Manufacturing Practice

Medicinal Products for Human and Veterinary Use

Annex 11: Computerised Systems

Legal basis for publishing the detailed guidelines: Article 47 of Directive 2001/83/EC on

the Community code relating to medicinal products for human use and Article 51 of Directive

2001/82/EC on the Community code relating to veterinary medicinal products. This document

provides guidance for the interpretation of the principles and guidelines of good

manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC

for medicinal products for human use and Directive 91/412/EEC for veterinary use.

Status of the document: revision 1

Reasons for changes: the Annex has been revised in response to the increased use of

computerised systems and the increased complexity of these systems. Consequential

amendments are also proposed for Chapter 4 of the GMP Guide.

Deadline for coming into operation: 30 June 2011

Commission Européenne, B-1049 Bruxelles / Europese Commissie,

B-1049 Brussel - Belgium

Telephone: (32-2) 299 11 11

Principle

This annex applies to all forms of computerised systems used as part o