GovWire

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 Current Members of the UK GLP compliance programme (PDF, 228 KB, 17 pages)

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 programme (PDF, 228 KB, 17 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 2019 to 2020

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.

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

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