The UK GLP Compliance Monitoring Programme is the mechanism whereby the GLP compliance of test facilities that conduct regulatory studies is assessed and monitored. In simple terms, test facilities are subject to inspections by the Good Laboratory Practice Monitoring Authority (GLPMA), the government body charged with enforcing the GLP regulations.
The frequency of GLP compliance monitoring inspections is determined by the outcome of a risk assessment that is conducted in accordance with current GLPMA risk assessment procedures.
In this section...
- Which test facilities need to be members of the UK GLP Compliance Monitoring Programme?
- How can a facility join the compliance monitoring programme?
- How can the GLP compliance status of a test facility be checked?
- What do the test types on a GLP compliance statement mean?
- Classification of test facilities and fees
- How can a facility leave the compliance monitoring programme?
Which test facilities need to be members of the UK GLP Compliance Monitoring Programme?Test facilities that conduct regulatory studies must, by law, be members of the Compliance Programme. Test facilities that are contracted to conduct work which forms just a part of a larger regulatory study are also usually obliged to be members of the Compliance Programme.
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 these circumstances the study director who has overall responsibility for the study should ensure that the GLPMA guidance is followed.
How can a facility join the compliance monitoring programme?Facilities that wish to conduct GLP studies must first join the compliance monitoring programme. The process for joining the compliance monitoring programme is outlined below:
- implementation of the appropriate systems to ensure that the facility can operate in compliance with the principles of GLP
- completion and submission of an application form to the GLPMA
- GLPMA review of the application
- acceptance of the facility as a prospective member of the programme
- implementation inspection of the facility by the GLPMA
- issue of the inspection report by the GLPMA and resolution of any non compliances identified
- acceptance as a full member of the UK GLP compliance monitoring programme and issue of a ‘Statement of GLP Compliance’.
The application form is available here:
Completed application forms should be emailed to the GLP Monitoring Authority at GLP@mhra.gsi.gov.uk
How can the GLP compliance status of a test facility be checked?
A test facility that is a member of the UK GLP Compliance Programme will, after a satisfactory inspection by the GLPMA, be issued with a 'Statement of GLP Compliance'. This statement gives the name and address of the test facility, the date on which the inspection was carried out, and an indication of the type(s) of work that is conducted in compliance with the Principles of GLP at that test facility.
All facilities within the UK GLP Compliance Programme should be able to provide a Statement of Compliance on request.
The GLPMA also publishes a list of current members of the UK compliance monitoring programme.
The published list will not include prospective members and may not include facilities that operate from premises that also serve as a domestic residence.
If a test facility is not present on the list, please contact the GLPMA (via the general mailbox) for clarification of a facilities status. The GLPMA can also provide guidance regarding whether a test facility has historically been a member of the UK compliance monitoring programme.
What do the test types on a GLP compliance statement mean?
This guidance document provides guidance on which test type categories cover which types of regulatory study.
Classification of test facilities and fees
Test facilities, which are part of the UK GLP Compliance Monitoring Programme, are classified according to the number of Inspector-days taken to inspect the premises and activities. This classification determines the annual fee payable for their membership of the Compliance Programme.
The fees are set at levels so that they meet that part of the expenditure of the GLPMA, which is reasonably attributable to the cost of inspecting and providing services.
Fees for 2012 - 2013
There is no fee rise this year and fees for all categories are as 2011 - 2012.
Fees for 2011 - 2012
|Facility type||Annual fee|
Category 1 and 2 sites are typically inspected annually.
Fee arrangements for GCP Clinical Laboratories and GMP QC laboratories can be found in the fees for inspection section.
How can a facility leave the compliance monitoring programme?
Facilities wishing to withdraw from the programme should contact the GLPMA stating this intention.