Good Laboratory Practice: Background and structure

Good Laboratory Practice (GLP) embodies a set of principles that provides a framework within which studies are planned, performed, monitored, recorded, reported and archived.

Laboratory technicians

Definition of Good Laboratory Practice

Good Laboratory Practice (GLP) embodies a set of principles that provides a framework within which studies are planned, performed, monitored, recorded, reported and archived. These studies are undertaken to generate data by which the hazards and risks to users, consumers and third parties, including the environment, can be assessed for pharmaceuticals, agrochemicals, veterinary medicines, industrial chemicals, cosmetics, food and feed additives and biocides.

GLP helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments.

Requirement to comply with the principles of GLP

In the European Union and many other parts of the world it is a regulatory requirement that studies undertaken to demonstrate the health or environmental safety of new chemical or biological substances should be conducted in compliance with the principles of GLP.

In the United Kingdom these requirements are contained within The Good Laboratory Practice Regulations, Statutory Instrument 1999 No 3106 (external link), as amended by Statutory Instrument 2004 No. 994: The Good Laboratory Practice (Codification Amendments Etc.) Regulations 2004 (external link).

These regulations require that any test facility which conducts, or intends to conduct, regulatory studies must be a member of the UK GLP Compliance Monitoring Programme. These regulations define a 'regulatory study' as a non-clinical experiment or set of experiments:

(a) in which an item is examined under laboratory conditions or in the environment in order to obtain data on its properties or its safety (or both) with respect to human health, animal health or the environment

(b) the results of which are, or are intended, for submission to the appropriate regulatory authorities

(c) compliance with the principles of good laboratory practice is required in respect of that experiment or set of experiments by the appropriate regulatory authorities (whether or not compliance with the said principles in respect of that experiment or set of experiments is also a legislative requirement).

Work that does not constitute a regulatory study as defined above (or an integral part thereof) is not required to be conducted in compliance with the principles of GLP. For example, work undertaken by Quality Control laboratories in support of final product release, or laboratory work in support of human clinical trials, does not require to be conducted in compliance with the principles of GLP.

The UK Good Laboratory Practice Monitoring Authority

Responsibility for verification of adherence to the Principles of Good Laboratory Practice is a devolved matter, thus the UK GLP Monitoring Authority (GLPMA) is a body consisting of the Secretary of State for Health, the National Assembly for Wales, the Scottish Ministers and the Department of Health and Social Services for Northern Ireland. Any one of the above acting alone or jointly may perform its functions. The UK GLP Monitoring Authority may appoint such persons as they think necessary for the proper discharge of their functions. In practice the GLPMA are a team based within the Inspection, Enforcement and Standards Division of the MHRA.

Responsibility for verification of adherence to the Principles of Good Laboratory Practice is a devolved matter, thus the UK GLP Monitoring Authority (GLPMA) is a body consisting of the Secretary of State for Health, the National Assembly for Wales, the Scottish Ministers and the Department of Health and Social Services for Northern Ireland. Any one of the above acting alone or jointly may perform its functions. The UK GLP Monitoring Authority may appoint such persons as they think necessary for the proper discharge of their functions. In practice the GLPMA are a team based within the Inspection, Enforcement and Standards Division of the MHRA. The GLPMA team members have a varied background and as a consequence of this have a good understanding of a broad range of scientific disciplines. Areas of expertise include analytical and physical chemistry, ecotoxicology, toxicology, applied biology, biochemistry and physiology. Prior to joining the agency, all of the inspectors worked within industry performing a variety of roles. The Head of the GLPMA is:

Andrew J Gray BSc, PhD
Head of GLPMA
Senior Inspector, Buckingham Palace Road, London
andrew.gray@mhra.gsi.gov.uk

The GLPMA team members have a varied background and as a consequence of this have a good understanding of a broad range of scientific disciplines. Areas of expertise include analytical and physical chemistry, ecotoxicology, toxicology, applied biology, biochemistry and physiology. Prior to joining the agency, all of the inspectors worked within industry performing a variety of roles.

What does the GLPMA do?

The team perform a variety of inspections including compliance monitoring inspections, implementation inspections of new facilities and may also perform audits of individual studies if this is requested by a receiving authority. These study specific audits can take place either in the UK or abroad if work has been conducted in a non-OECD member state.

The UK GLP Monitoring Authority works to ISO 9002 and is audited by the British Standards Institute. This accreditation has been in place following a successful first audit in March 1999.

In addition to performing monitoring inspections of facilities within the GLP Compliance Monitoring Programme, the GLPMA also perform inspections of contract GMP QC testing laboratories, GMP QC Contract Laboratories and GCP for Clinical Laboratories.

The Monitoring Authority formulates UK policy on the interpretation of the Principles of Good Laboratory Practice and responds to enquiries from industry, other government departments and other interested bodies in this regard.

GLPMA staff participate in external training courses and conferences, and agency symposia.

Committees and meetings

The GLPMA has set up two committees within the UK that meet annually: the GLP Consultative Committee and the Regulatory Authorities Liaison Committee.

The Consultative Committee provides information to representatives of trade associations, other government departments and other organisations that may be affected by GLP issues. Current members of the Consultative Committee are listed below:

Trade associations:

  • Association of British Pharmaceutical Industry
  • Crop Protection Association
  • The Research Quality Assurance Association
  • Chemical Aspects of Toxicology Discussion Group
  • Association of Independent Research Testing Organisations
  • British Association of Chemical Specialties

Other government departments:

  • MHRA (pharmaceuticals, medical devices)
  • Veterinary Medicines Directorate
  • Chemicals Regulation Directorate
  • Food Standards Agency (feed additives, novel animal and human foods, food additives and food contaminants)
  • Environment Agency
  • CEFAS
  • Welsh Assembly
  • Scottish Executive

Other organisations:

  • United Kingdom Accreditation Service (UKAS)
  • Scientific Archivists Group

The Liaison Committee comprises representatives from all the receiving authorities in the UK listed above. The objectives of this committee are to report and provide information with respect to the status of UK, EC and OECD facilities claiming compliance with GLP and to act as a forum in which the Monitoring and Regulatory authorities may discuss matters of interpretation of European law and other topics of mutual interest.

Minutes of previous meetings

Minutes of the Good Laboratory Practice Consultative Committee meetingPDF file (opens in new window) (77Kb) - 26 April 2012
Minutes of the Good Laboratory Practice Consultative Committee meetingPDF file (opens in new window) (86Kb) - 9 May 2011
Minutes of the Good Laboratory Practice Consultative Committee meetingPDF file (opens in new window) (178Kb) - 23 March 2010 
Minutes of the Good Laboratory Practice Consultative Committee meetingPDF file (opens in new window) (99Kb) - 19 March 2009
Minutes of the Good Laboratory Practice Consultative Committee meetingPDF file (opens in new window) (95Kb) - 31 March 2008

International activities

The GLPMA represents the UK at a number of international forums concerned with the application of the Principles of Good Laboratory Practice. As the Head of the UK GLPMA, Andrew Gray is a member of the OECD and EC GLP working groups and as such provides a UK link to both organisations.

The GLPMA has made significant contributions to the OECD publications that interpret the Principles of Good Laboratory Practice and has actively participated in efforts to harmonise inspection activities both in the EU and globally via the OECD.

Contacts for further information

If you have a question regarding GLP compliance in the UK, which is not answered by the information on these web pages, you may send your question to the UK GLPMA general mailbox at: glp@mhra.gsi.gov.uk  


Page last modified: 18 June 2013