Specification-driven acceptance criteria for validation of biopharmaceutical processes.

ABSTRACT: Intermediate acceptance criteria are the foundation for developing control strategies in process validation stage 1 in the pharmaceutical industry. At drug substance or product level such intermediate acceptance criteria for quality are available and referred to as specification limits. However, it often remains a challenge to define acceptance criteria for intermediate process steps. Available guidelines underpin the importance of intermediate acceptance criteria, because they are an integral part for setting up a control strategy for the manufacturing process. The guidelines recommend to base the definition of acceptance criteria on the entirety of process knowledge. Nevertheless, the guidelines remain unclear on how to derive such limits. Within this contribution we aim to present a sou

SUBMITTER: Marschall L 

PROVIDER: S-EPMC9537461 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature