As a test facility, comply with regulatory requirements for carrying out product safety tests for human health, animal health or the environment.

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, 377KB) to the GLPMA.

The UK GLPMA reviews the application and approves your facility as a prospective member of the programme.

All facilities within the UK GLP compliance programme should be able to provide a statement of compliance on request.

See current members of the UK GLP compliance programme (PDF, 105KB, 15 pages) .

Email GLP@mhra.gsi.gov.uk for information about facilities that are not on the list.

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’.

To leave the GLPMA email glp@mhra.gsi.gov.uk.

Membership fees for 2013 to 2014

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 £15,504
Category 2 £10,336
Category 3 £5,168
Category 4 £2,584
Category 5 £1,380

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.

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 deficiency which has resulted or will result in the test facility or part of it, or a study or part of it not being in compliance with the principles of GLP.

Major deficiency

A deficiency that if not addressed immediately may lead to a facility, system or study being out of compliance. A failure of one of the basic GLP quality system elements.

Deficiency

A departure from the principles of GLP which is not considered critical or major, or is an isolated incident.

Actions after an inspection

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.

You should receive a post-inspection letter within 15 working days detailing any deficiencies identified.

You must respond with details, including timelines, of the corrective and preventative remedial actions, implemented or proposed, to address the deficiencies and prevent them happening again.

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

See GLP Deficiency Data 2013 Annual Report (PDF, 921KB, 22 pages) .

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 Excel Spreadsheet, 154KB) to tell the GLPMA about any significant changes to your test facility and send it to GLP@mhra.gsi.gov.uk.

View guidance on completion of the form used to notify the GLPMA of changes within the GLP test facility (PDF, 70.6KB, 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 (PDF, 105KB, 8 pages) to GLP@mhra.gsi.gov.uk.

View guidance on completing the form (PDF, 110KB, 5 pages) .

Further guidance and text of regulations

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

Guidance has been issued by the GLPMA on the current interpretations and expectations.

Guidance on the test types stated on GLP compliance statements (PDF, 70.2KB, 2 pages)

Guidance for audit of the quality assurance (PDF, 79.9KB, 3 pages)

GLPMA expectations when using a contract quality assurance (PDF, 78.1KB, 3 pages)

Guidance on the content of the quality assurance statement (PDF, 77.6KB, 3 pages)

Guide to the UK GLP Regulations (PDF, 50.1KB, 24 pages)

Registration, evaluation, authorisation and restriction of chemicals (REACH) (PDF, 65.9KB, 1 page)

Pesticide efficacy studies intended for united states environmental protection agency (PDF, 66.4KB, 1 page)

Guidance on retention of study data (PDF, 66.2KB, 1 page)

Contact for further information

If you have any questions about GLP compliance you should email GLP@mhra.gsi.gov.uk.