GLP and GMP

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.

Good Manufacturing Practice

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.

View current MHRA Certificate No: Insp GMP 14849/5712-0008

Butterworth have also had general GMP inspections by the FDA on four occasions in relation to various NDA and ANDA applications by customers.  The last of these was in June 2009.

View FDA Letter of approval 2009 

To see a redacted copy of the full FDA report, please contact David Hawkins, QA Manager, david.hawkins@butterworth-labs.co.uk

Good Laboratory Practice

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  current GLP Certificate

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 others can be found here. 

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