(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.

Good laboratory practice (GLP) for safety tests on chemicals