GMP guidelines similar to Part 11 requirements

[COLOR=“blue”]EU GMP Guideline

The GMP guideline of the European Medicines Agency (EMEA), Directive 2003/94/EC, delineates the legal requirements for good manufacturing practice in the EU, including the need to maintain a system of documentation. The main requirements affecting electronic records are that the data is available in humanreadable form, available for the required time, and protected against loss or damage. The objective of this guideline is to provide requirements for ensuring reliability in using the electronic record and electronic signature systems in those contexts.[/color]

[COLOR=“darkred”]PIC/S Guidance

The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S) published guidance called “Good Practices for Computerized Systems in Regulated GxP Environments” in July 2004. The guidance provides background information and recommendations regarding inspection of and training concerning computerized systems. It contains a section on electronic records and signatures aligned to EU GMP expectations.[/color]

[COLOR=“green”]ICH Guideline

The International Conference on Harmonization (ICH guideline, ICH Q7A, called “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients,” is the first GMP guideline that has been harmonized for the United States, EU, and Japan. ICH Q7A has been published as Annex 18 in “EU GMP Guideline” in July 2001. In addition, ICH Q7A has been adopted by Australia, Japan, and PIC/S.[/color]