Multivariate statistical process control in product quality review assessment – A case study
Publication date: Available online 7 August 2017
Source:Annales Pharmaceutiques Françaises
Author(s): M. Kharbach, Y. Cherrah, Y. Vander Heyden, A. Bouklouze
According to the Food and Drug Administration and the European Good Manufacturing Practices (GMP) guidelines, Annual Product Review (APR) is a mandatory requirement in GMP. It consists of evaluating a large collection of qualitative or quantitative data in order to verify the consistency of an existing process. According to the Code of Federal Regulation Part 11 (21 CFR 211.180), all finished products should be reviewed annually for...