This paper is an interpretive response to Annex 2 of Eudralex—Volume 4; the European Union (EU) guidelines for good manufacturing practice (GMP) of medicinal products for human and veterinary use. The purpose of this paper is to share an interpretation of key areas of Annex 2, providing enhanced clarity for the industry.
This paper supports a scientific and risk-based approach that identifies the biological active substance manufacturing requirements, and the types of control that meet those requirements. Its focus is around use of a QRM approach to assess environmental control requirements for a low bioburden drug substance process, and that use of closed systems is an effective way to reduce risk and this minimize need for environmental controls. Use of closed systems in reduced area classification enables a significant reduction in costs for the industry.