# Good laboratory practice (GLP) for safety tests on chemicals

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/c192b220-1fab-4c17-b8f8-66eb36773fc6
Type: Detailed Guide
Published: December 18, 2014
Updated: April 29, 2026

> This guidance document details the Good Laboratory Practice (GLP) compliance monitoring programme managed by the UK Medicines and Healthcare products Regulatory Agency (MHRA). The programme is mandatory for any UK facility conducting regulatory safety studies on pharmaceuticals, chemicals, and food additives. The regulatory framework is established under the UK GLP Regulations (Statutory Instruments 1999 No. 3106 and 2004 No. 994), which are based on global OECD principles. Under these regulations, facilities are typically inspected every 12 to 30 months, with initial implementation inspections occurring within 12 weeks of a new application. Inspections assess quality systems, facilities, and study data to ensure integrity and safety. Violations are graded into three categories: Critical deficiencies, which involve systemic failures or unreliable data; Major deficiencies, representing significant departures from GLP principles that risk future compliance; and Other deficiencies, which are minor procedural deviations. Required actions for facilities include providing a verbal response during the inspection and a formal written response within 25 working days of receiving the final report. This response must detail specific corrective actions and completion dates. Serious non-compliance or evidence of fraud can lead to for-cause inspections, suspension from the compliance programme, disqualification of specific study data, or legal action led by the MHRA Enforcement Group. Facilities must also proactively notify the UK GLP Monitoring Authority of any significant organizational changes or the use of non-GLP subcontractors.

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## Content

(GxP) inspections and coronavirus COVID-19) Information on new arrangements for inspections during the coronavirus (COVID-19) outbreak. Guidance for Good Laboratory Practice ( GLP ) facilities in relation to coronavirus (COVID-19) Overview Any test facility which conducts, or intends to conduct, regulatory studies must comply with good laboratory practice ( GLP ) regulations when carrying out safety tests on: pharmaceuticals agrochemicals veterinary medicines industrial chemicals cosmetics additives for human food and animal feed biocides The test facility must belong to the UK GLP compliance monitoring programme, run by the UK GLP Monitoring Authority (UK GLPMA ). The programme is only open to facilities in the UK. Test facilities that are contracted to work on part of a larger regulatory study should also usually be members of the compliance programme. Exceptions There may be exceptional circumstances when a part of a regulatory study may need to be contracted out to a test facility that is not a member of the compliance programme. In this case, the study director must make sure that GLPMA guidance is followed. Apply to join the GLP compliance monitoring programme Complete and submit a UK GLP compliance monitoring programme application form ( MS Word Document , 747 KB ) to the GLPMA . See The UK GLPMA reviews the application and provided the application requirements are met will approve your facility as a prospective member of the programme. Within 12 weeks the GLPMA carries out an implementation inspection of your facility and systems to: confirm that the necessary GLP quality systems have been set up and appear appropriate for the type of regulatory studies that will be conducted confirm the suitability of the premises and facilities examine data and supporting records if any are available You must respond to any issues raised in the report giving details of corrective actions. Once the inspector is satisfied, the GLPMA accepts your facility as full member of the programme and issues a ‘statement of GLP compliance’. UK GLP compliance monitoring programme members See Current-Members of the UK GLP Compliance monitoring Programme Version 17 ( PDF , 335 KB , 14 pages ) All facilities within the UK GLP compliance programme should be able to provide a statement of compliance on request. Email gxplabs@mhra.gov.uk for information about facilities not on the list. To leave the UK GLP compliance monitoring programme email gxplabs@mhra.gov.uk . Membership fees for 2023 to 2024 GLPMA charges an annual fee for membership according to the test facility category. Your category will be determined as part of the implementation inspection process. It is based on the time it would take to inspect the premises and activities and will be reviewed at future inspections. Facility type Annual fee Category 1 £36,510 Category 2 £29,208 Category 3 £21,906 Category 4 £14,604 Category 5 £7,302 Category 6 £3,651 Category 7 £1,825 Make a payment to MHRA . GLP monitoring inspections After the initial implementation inspection, a test facility can expect to be inspected every 12 to 30 months. The UK GLPMA normally gives at least 10 working days’ notice. There will be some circumstances when the inspection may be unannounced or at short notice. Monitoring inspections involve: a review of the GLP quality systems an inspection of facilities an audit of completed and on-going studies You must keep verified copies of any returned study reports and associated raw data for a minimum of 2 years or 1 inspection cycle. At the end of the inspection the inspector will give you a verbal summary of the inspection findings and allow you the opportunity to correct any misunderstandings. For-cause inspections UK GLPMA carries out for-cause inspections if serious concerns are raised about a test facility, including: allegations made by a whistleblower possible fraud serious non-compliance issues Audits Any regulatory authority in the UK or overseas can ask the GLPMA to audit a study that has been submitted to them. The GLPMA checks that the study complies with the principles of GLP . Grading of inspection findings Deficiencies found during inspections are graded at 3 levels. Critical deficiency a) Where evidence exists that significant departure(s) from the Principles of GLP has occurred resulting in: i) the test facility, or a part thereof, or a study is not in compliance with the Principles of GLP and/or ii) the study data are unreliable and/or iii) a combination of several “Major” findings (defined in (c)) across the basic GLP quality systems, indicating a systemic quality assurance failure, and/or b) Where inappropriate, insufficient or untimely corrective action has taken place regarding previously reported Major non-compliances (defined in (c)) Major deficiency c) A non-critical finding where evidence exists that a significant departure from the Principles of GLP has occurred: i) that may not have developed into a critical issue, but if not addressed immediately may lead to a facility, system or study being out of compliance, and/or ii) where evidence exists of a failure of one of the basic GLP quality system elements, and/or iii) a combination of several “other” findings, none of which on their own may be major, but which may together represent a major finding Other deficiency d) Where evidence exists that a departure from the Principles of GLP has occurred, and/or established guidelines and/or procedural requirements but it is neither Critical nor Major Actions after an inspection After the inspection closing meeting, you will receive an inspection report within 25 working days confirming any deficiencies found. You must respond to the inspector by email to confirm the proposed corrective actions and dates for when these actions will be completed. Guidance on responding to an Inspection Report The inspector will review your response. Once the inspector is satisfied with the actions proposed a statement of GLP compliance will be issued. At this point a risk assessment will be carried out and the date and scope of your next compliance monitoring inspection will be decided. Risk-based compliance programme For GLP , areas considered to determine a test facility’s risk include: number, severity and nature of deficiencies raised in previous inspections volume of GLP work undertaken nature and purpose of the work Regulatory or enforcement action Following an inspection or a study audit if there are serious concerns relating to the GLP compliance of the test facility or of studies conducted there, the GLPMA could: suspend the membership of the UK GLP compliance programme disqualify the GLP status of specified studies The need for any regulatory action is considered on a case-by-case basis. If an inspection has identified potential offences, the matter will be referred to the MHRA Enforcement Group which will lead the subsequent investigation and any resulting legal action. Notify GLPMA of changes at a GLP test facility Use the notification of change form ( MS Word Document , 247 KB ) to tell the GLPMA about any significant changes to your test facility and send it to gxplabs@mhra.gov.uk . View guidance on completion of the form used to notify the GLPMA of changes within the GLP test facility ( PDF , 54.6 KB , 2 pages ) . Some changes could affect the GLPMA risk assessment for your facility, which could change the date, duration or scope of future inspections. Use of non- GLP facilities In exceptional circumstances part of your regulatory study may have to be carried out by a non- GLP facility. You should email the non-GLP phase notification form ( MS Excel Spreadsheet , 57 KB ) to gxplabs@mhra.gov.uk . Further guidance and text of regulations UK GLPMA Guidance on content of QA Statement 2022 ( PDF , 143 KB , 3 pages ) UK GLPMA Study Reporting Guidance 2022 ( PDF , 117 KB , 4 pages ) Guidance on retention of study data Statutory Instrument 1999 No. 3106: The Good Laboratory Practice Regulations Statutory Instrument 2004 No. 994: The Good Laboratory Practice (Codification Amendments etc) Regulations Organisation for Economic Development ( OECD ) series on principles of good laboratory practice ( GLP ) and compliance monitoring Organisation for Economic Development ( OECD ) Good Laboratory Practice: Frequently asked questions (FAQ) Guidance has been issued by the GLPMA on the current interpretations and expectations. Guidance on the test types stated on GLP compliance statements ( PDF , 70.2 KB , 2 pages ) Guidance for audit of the quality assurance ( PDF , 79.9 KB , 3 pages ) GLPMA expectations when using a contract quality assurance ( PDF , 78.1 KB , 3 pages ) Selection and use of GLP Test Sites located outside the UK ( PDF , 48.5 KB , 1 page ) UK GLP compliance monitoring programme application form ( MS Word Document , 747 KB ) non-GLP phase notification form ( MS Excel Spreadsheet , 57 KB ) guidance on completing the form ( PDF , 105 KB , 8 pages ) Guidance on the use of GLP study report amendments ( PDF , 71.9 KB , 2 pages ) Stakeholder engagement meetings The UK GLPMA hold periodic meetings with stakeholders. The minutes of the last meeting can be found here UK GLPMA Consultative committee meeting minutes May 2021 ( PDF , 198 KB , 7 pages ) . If you are interested in attending subsequent meetings please contact: gxplabs@mhra.gov.uk Contact for further information If you have any questions about GLP compliance you should email gxplabs@mhra.gov.uk .

## Attachments

- [GLP Deficiency Data 2016/17 Annual Report](https://assets.publishing.service.gov.uk/media/5aa2ac9040f0b66b5fb4b2f0/GLPMA_Deficiency_Data_2016-2017_Annual_Report.pdf)
- [notification of change form](https://assets.publishing.service.gov.uk/media/5e7cce25e90e0706f24fdf67/GLPMA_change_notification_form__6_.doc)
- [guidance on completion of the form used to notify the GLPMA of changes within the GLP test facility](https://assets.publishing.service.gov.uk/media/5a7f6fbce5274a2e87db5d7b/Guidance_on_completion_of_the_change_form.pdf)
- [Guidance on the test types stated on GLP compliance statements](https://assets.publishing.service.gov.uk/media/5a7f9e4ee5274a2e87db6f0d/Guidance_on_test_types_on_GLP_Compliance_statements.pdf)
- [Guidance for audit of the quality assurance ](https://assets.publishing.service.gov.uk/media/5a8061af40f0b62305b8ad21/audit_of_qa.pdf)
- [GLPMA expectations when using a contract quality assurance](https://assets.publishing.service.gov.uk/media/5a8074c040f0b62305b8b423/contract_QA.pdf)
- [Guidance on the content of the quality assurance statement](https://assets.publishing.service.gov.uk/media/5a74fc4840f0b6399b2afc11/Guidance_on_the_Content_of_the_Quality_Assurance_Statement.pdf)
- [Guidance on archiving](https://assets.publishing.service.gov.uk/media/5a7c7527ed915d6969f45009/Guidance_on_archiving.pdf)
- [UK GLP compliance monitoring programme application form](https://assets.publishing.service.gov.uk/media/5d810a8940f0b61c9df679ee/UK_GLP_compliance_monitoring_programme_application_form.doc)
- [Current Members of the UK GLP compliance programme](https://assets.publishing.service.gov.uk/media/689b50aa7b0b51a850e94090/Current-Members_of_the_UK_GLP_Compliance_monitoring_Programme_Version_16.pdf)
- [Guidance on retention of study data](https://assets.publishing.service.gov.uk/media/5a8083b7ed915d74e622ee59/Guidance_on_retention_of_study_data.pdf)
- [non-GLP phase notification form](https://assets.publishing.service.gov.uk/media/5a803394e5274a2e8ab4ec6c/Non-GLP_phase_notification_form.xls)
- [guidance on completing the form ](https://assets.publishing.service.gov.uk/media/5a7f2537e5274a2e8ab4a646/Use_of_non_GLP_facilities_guidancev2.pdf)
- [Guidance on the use of GLP study report amendments](https://assets.publishing.service.gov.uk/media/5a807ba640f0b62302693c68/Guidance_on_the_use_of_GLP_study_report_amendments.pdf)
- [Selection and use of GLP Test Sites located outside the UK](https://assets.publishing.service.gov.uk/media/5a7f171540f0b62305b85022/Selection_and_use_of_GLP_test_sites_located_outside_the_UK.pdf)
- [Deficiency data from 2017-2018](https://assets.publishing.service.gov.uk/media/5c334d72e5274a65a8b44f9e/GLP_Deficiency_metrics_2017_2018.pdf)
- [UK GLPMA Consultative committee meeting minutes May 2021](https://assets.publishing.service.gov.uk/media/618cec64d3bf7f0560be61e6/UK_GLPMA_Consultative_committee_meeting_minutes_May_2021.pdf)
- [UK GLPMA Guidance on content of QA Statement 2022](https://assets.publishing.service.gov.uk/media/62d97dbae90e071e7cbe1f22/UK_GLPMA_Guidance_on_content_of_QA_Statement_2022.pdf)
- [UK GLPMA Study Reporting Guidance 2022](https://assets.publishing.service.gov.uk/media/62d97dc5e90e071e7defba42/UK_GLPMA_Study_Reporting_Guidance_2022.pdf)
- [Current-Members of the UK GLP Compliance monitoring Programme Version 17](https://assets.publishing.service.gov.uk/media/69f1f609b73b862445e3ac25/Current-Members_of_the_UK_GLP_Compliance_monitoring_Programme_Version_17.pdf)