GMP and GLP


Good Manufacturing Practice (MHRA and FDA)

First inspected by MCA in 1994 with continued compliance with the principles and guidelines of Good Manufacturing Practice as laid down in Directives 91/356/EEC and 91/412 EEC as they relate to Quality Control Laboratories.

Within the UK there is no requirement for a stand alone contract laboratory to have a licence or authorisation; however a GMP certificate is issued by the MHRA following an inspection.

MHRA Certificate Human Medicines 

MHRA Certificate Veterinary Medicines

Butterworth also have regular GMP inspections by the FDA. To see a redacted copy of the latest FDA report, please contact Stuart Davey, our QA Manager.

 

Good Laboratory Practice (GLP)

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

View Statement of Compliance

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 here under the relevent GMP and GLP sections. 

 

The term Good Laboratory Practice (GLP) is a generic term that 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.

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