Technical Review: European GMP Annex 1 – 2008 Edition

The GMP guidance for sterile manufacture was revised in 2003 to accommodate changes from various cleanroom standards and create a single unified cleanroom standard, ISO4644-1. The introduction to ISO 14644-1 states this as:

Annex 1 of the EC Guide to Good Manufacturing Practice (GMP) provides supplementary guidance on the application of the principles and guidelines of GMP to sterile medicinal products. The guidance includes recommendations on standards of environmental cleanliness for clean rooms. The guidance has been reviewed in the light of the international standard EN/ISO 14644-1 and amended in the interests of harmonisation but taking into account specific concerns unique to the production of sterile medicinal products.