In the context of the EU GMP (Good Manufacturing Practice) guidelines, the annexes provide supplementary documents that offer specific regulations and guidelines for particular areas of GMP. While the main part of the GMP guidelines covers general requirements for production processes and quality control in pharmaceutical manufacturing, the annexes delve into particular topics or specialized forms of manufacturing.
Each annex focuses on a different specific topic, such as the manufacture of sterile products, procedures for certain technological applications, or the examination of specific quality aspects. These annexes help manufacturers better understand and address the unique challenges and requirements in various areas. Currently, there are annexes available from Annex 1 to Annex 20.