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. Because this has the word “Laboratory” in it it is often used to describe (incorrectly) the GMP principles applicable to QC labs. QC labs actually work to Good Quality Control Laboratory Practice (GQCLP), and this is the term used in EU GMP to describe the GMP principles for QC laboratory work. The term is used in Chapter 6 of GMP covering Quality Control. Because GQCLP is a bit of a mouthful as an acronym, the shorter term of GCLP (Good Control Laboratory Practice) is often used instead.
QC labs also need to work to the other relevent chapters of GMP too, such as training (Chapter 2) and documentation (Chapter 4) for example.
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