Posts tagged ‘QC’
April 3, 2012
Three key personnel are named on a pharmaceutical manufacturing site’s Manufacturing Licence. These are the Head of Production, the Head of Quality Control and the Qualified Person(s). Their roles and responsibilities are also defined in GMP in Chapters 2 (Personnel) and Annex 16 (Certification by a Qualified Person and Batch Release). These individuals have a major influence on product quality and GMP. Their duties are described below: Read more
March 29, 2012
This is a commonly asked question on my training courses which is generally misunderstood. Quality Control (QC) laboratories that are based at classic pharmaceutical manufacturing sites DO NOT work to GLP. GLP stands for Good Laboratory Practice, and this is the system used to cover the performance of toxicological studies on an animal, done as part of medicinal product development. Read more
January 24, 2012
EU GMP states that Quality Control (clause 1.3) “is concerned with sampling, specifications and testing, and with the organisation, documentation and release procedures”. In essence, QC is a sampling, testing, monitoring and checking activity.