INTRODUCTION
About Eudralex Annex 11 and its importance
Eudralex is the collection of rules and regulations governing medicinal products (for human use as well as for veterinary use) in European Union (EU). Eudralex consists of 10 volumes, of which only Volume 1 (concerning medicinal products for human use) and Volume 5 (concerning medicinal products for veterinary use) present official legislation. The basic legislation is supported by a series of guidelines that are published within the other eight
volumes. Eudralex Volume 4 consists of three Parts and a series of nineteen Annexes. Within Part 1, guidelines pertaining to Documentation are presented in Chapter 4. Moreover, Annex 11 included guidelines for the use of computerized systems within GMP-regulated activities. When used in conjunction with Chapter 4, Annex 11 provides guidance for the use of electronic documents (electronic records and electronic signatures) within the GMP
environment.
Background
Similar to US FDA’s 21 CFR Part 11, groups within the European pharmaceutical industry came together alongside the Commission of the European Committees in 1991 to adopt 2 new directives. These directives would lay the principles and guidelines for good manufacturing practice for the production and distribution of medicinal products in Europe. Annex 11 is part of Volume 4 and specifically refers to computer systems. In 1991, the Pharmaceutical Inspection Co-oP (PIC) created a document defining their requirements for computer systems that would later be given the name Annex 5, and even later renamed as Annex 11 to become part of the EU GMP Guidelines. In 1992 it became part of the GLP and GCP requirements for Europe, unifying the requirements for the management of electronic records and signatures in pharmaceutical companies.
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