Good Laboratory Practice: Guidance and legislation

The UK GLP Regulations

The UK GLP regulations are available here:

Statutory Instrument 1999 No. 3106: The Good Laboratory Practice Regulations (external link)
Statutory Instrument 2004 No. 994: The Good Laboratory Practice (Codification Amendments Etc.) Regulations (external link)

The UK GLP Regulations are accompanied by the Guide to the Regulations which is available here:

Guide to the UK GLP Regulations (51Kb)

The GLP Pocket-Book is a pocket-sized publication containing the Good Laboratory Practice (GLP) Regulations 1999 and the Guide to the GLP Regulations. This is a useful and valuable aid in applying the principles of GLP.

The GLP Pocket-Book is distributed by the MHRA publications team. Please order a copy using the link below.

The GLP Pocket-Book

OECD Principles, guidance and advisory documents

The OECD publications listed below can be obtained from the OECD website (external link):

1. OECD Principles of Good Laboratory Practice (as revised in 1997). 1998
2. Guidance for GLP Monitoring Authorities: Revised Guides for Compliance Monitoring Procedures for Good Laboratory Practice. 1995
3. Guidance for GLP Monitoring Authorities: Revised Guidance for the Conduct of Laboratory Inspections and Study Audits. 1995
4. GLP Consensus Document: Quality Assurance and GLP. 1999
5. GLP Consensus Document: Compliance of Laboratory Suppliers with GLP Principles. 1999
6. GLP Consensus Document: The Application of the GLP Principles to Field Studies. 1999
7. GLP Consensus Document: The Application of the GLP Principles to Short-term studies. 1999
8. GLP Consensus Document: The Role and Responsibilities of the Study director in GLP Studies. 1999
9. Guidance for GLP Monitoring Authorities: Guidance for the Preparation of GLP Inspection Reports. 1995
10. GLP Consensus Document: The Application of the Principles of GLP to Computerised Systems. 1995
11. Advisory Document of the Panel on Good Laboratory Practice: The Role and Responsibilities of the Sponsor in the Application of the Principles of GLP. 1998
12. Advisory Document of the Working Group on Good Laboratory Practice: Requesting and Carrying out Inspections and Study Audits in Another Country. 2000
13. Consensus Document of the Working group on Good laboratory Practice: The Application of the OECD Principles of GLP to the Organisation and Management of Multi-Site Studies. 2002
14. Advisory document of the Working group on Good Laboratory Practice “The Application of the Principles of GLP to in vitro studies” ENV/JM/MONO(2004)26
15. Establishment and Control of Archives that Operate in Compliance with the Principles of GLP

OECD guidelines can also be obtained from the OECD at 2, Rue Andre Pascal, 75775 Paris Cedex 16, France.

Guidance documents

A number of guidance notes have been issued by the GLPMA. The guidance notes focus on key areas where a number of deficiencies were identified during routine monitoring inspections. The purpose of the documents is to give clear guidance on the current interpretations and expectations of the GLPMA.

Guidance for audit of the quality assurance (QA) programme (48Kb)
GLPMA expectations when using a contract QA service (48Kb)
Guidance on the content of the quality assurance statement (48Kb)

Guidance on archiving:
Guidance on archiving (63Kb)

This booklet is also available for purchase in a pocket size version. For details please contact the Corporate Communications and Marketing Team:

Tel: 020 3080 6278
Email: conferences@mhra.gsi.gov.uk  

Use of non-GLP compliant facilities and exclusion of study phases from the claim of GLP compliance

Detailed guidance and an application form are available on exclusion of study phases from GLP compliance and the use of non-GLP facilities:

UK GLPMA policy on the use of non-GLP facilities for the conduct of study phases (55Kb)
Non-GLP notification form (144Kb)

Completed application forms should be emailed to the GLP Monitoring Authority (GLPMA) at GLP@mhra.gsi.gov.uk  

Policy statements

Policy statements are issued by the GLPMA to provide clarification on issues that may impact upon facilities conducting GLP studies in the UK.

Use of test sites in Canada (38Kb)
Pesticide efficacy studies for submission to the United states EPA (32Kb)
Registration, Evaluation, Authorisation and restriction of Chemicals (REACH) (29Kb)
Retention of study data and supporting records for inspection purposes (75Kb)

GCP Clinical Laboratories

The Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended) regulate the conduct of clinical trials in the United Kingdom. The regulations relate to persons or organisations that participate in any aspect of human clinical trials including organisations that analyse or evaluate samples collected as part of a clinical trial.

For more information, please visit our GCP for Clinical Laboratories section or contact us directly by emailing: GCPClinLab@mhra.gsi.gov.uk  

GMP QC Laboratories

Quality control testing, including stability testing of investigational and marketed medicinal products, is regarded as part of the manufacturing process. Laboratories providing this service should be operating in compliance with the EU Guide to GMP as it would apply to a laboratory.

For more information, please visit our Good Manufacturing Practice (GMP) section.