EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines
The rules governing medicinal products in the European Union
The EU legal framework for medicinal products guarantees high standards of quality and safety. It is based on the principle that medicinal products may be placed on the market only following a marketing authorisation granted by the competent authorities.
“The rules governing medicinal products in the European Union”, known as EudraLex is the collection of rules and regulations governing medicinal products in the European Union. Volume 4 of EudraLex contains guidance for the interpretation of the principles and guidelines of good manufacturing practices (GMPs) for medicinal products for human and veterinary use. In particular, the Annex I regulate the manufacturing of sterile medicinal products.
Interestingly, the paragraph 4.3 states that: “[...] Isolators are beneficial in assuring the required conditions and minimizing the microbial contamination associated with direct human interventions in the critical zone. Their use should be considered in the CCS. Any alternative approaches to the use of [...] Isolators should be justified.” So, if the choice was to use a Clean Room instead of an Isolator, this alternative approach should be justified.
- EudraLex - Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products
- Annex 1 - Manufacture of Sterile Medicinal Products
- EudraLex - The Rules Governing Medicinal Products in the European Union - Volume 4