Butterworth first became Members of the UK Good Laboratory Practice (GLP) Compliance programme in 1989 and have retained this status for Analytical Chemistry and Phys/Chem Testing
The MHRA Publish a number of documents on their website such as:
- Guidance for UK Manufacturer’s Licence and Manufacturer’s Authorisation Holders on the use of stand-alone contract laboratories
- GLPMA Expectations when using a contract quality assurance service
These and other useful documents can be found on the MHRA website under the relevant GMP and GLP sections.
The term Good Laboratory Practice (GLP) is a generic term that sometimes causes confusion when used to describe the quality control testing of medicinal products.
Compliance with the OECD Principles of GLP is a regulatory requirement when conducting non-clinical, safety studies of new chemical or biological substances. There is no legal requirement for the quality control testing of medicinal product to be conducted in accordance with the OECD Principles of GLP and there is no requirement for laboratories involved in quality control testing of medicinal products to be members of the UK GLP Compliance Programme. On the other hand, quality control laboratories that are testing medicinal products, including investigational medicinal products, should do so in accordance with GMP and in accordance with any details specified in the product specification file or the marketing authorisations