(AGENPARL) - Roma, 28 Giugno 2022(AGENPARL) – LONDON mar 28 giugno 2022
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 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
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All facilities within the UK GLP compliance programme should be able to provide a statement of compliance on request.
Email <a for information about facilities not on the list.
To leave the UK GLP compliance monitoring programme email <a
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.
| Facility type | Annual fee |
|---|---|
| Category 1 | £15,930 |
| Category 2 | £10,620 |
| Category 3 | £5,310 |
| Category 4 | £2,655 |
| Category 5 | £1,380 |
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 to tell the GLPMA about any significant changes to your test facility and send it to <a
View .
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 to <a
Further guidance and text of regulations
Guidance on retention of study data
Statutory Instrument 1999 No. 3106: The Good Laboratory Practice Regulations
Guidance has been issued by the GLPMA on the current interpretations and expectations.
See more information on the facilities inspected in Europe and the legislation around good laboratory practice on the European Commission’s website.
See guidance on implementing and maintaining risk-based quality assurance programme.
Stakeholder engagement meetings
The UK GLPMA hold periodic meetings with stakeholders. The minutes of the last meeting can be found here .
If you are interested in attending subsequent meetings please contact: <a
If you have any questions about GLP compliance you should email <a
Fonte/Source: https://www.gov.uk/guidance/good-laboratory-practice-glp-for-safety-tests-on-chemicals
