"Computerised Systems", Annex 11 to the EU’s GMP Guide

Re: Draft Annex 11 “Computerised Systems”

Dear Sir/Madam,

The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide comment on the draft Annex 11 “Computerised Systems” to the EU’s Guidelines to Good Manufacturing Practice (GMP) for Medicinal Products for Human and Veterinary Use. BIO represents more than 1,200 biotechnology companies, academic institutions, state biotechnology centers and related organizations in more than 31 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products.

GENERAL COMMENTS: The revised Annex 11 will enhance the ability of manufacturing authorisation holders to ensure the smooth introduction of computerised systems into manufacturing without a decrease in product quality, process control or quality assurance. Our specific comments below are directed toward clarifying the language of the draft Annex to further enhance its utility for manufacturing authorization holders.

CONCLUSION BIO appreciates this opportunity to provide comment on the draft Annex 11 “Computerised Systems” to the EU’s Guidelines to Good Manufacturing Practice (GMP) for Medicinal Products for Human and Veterinary Use, and we would be pleased to provide further input or clarification of our comments, as needed. Sincerely, /s/ Sara Radcliffe Vice President, Science & Regulatory Affairs Biotechnology Industry Organization