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Types of inspection
There are three types of Good Laboratory Practice (GLP) inspections:
- Implementation inspection: This is the first GLP inspection of a prospective member of the UK GLP Compliance Programme. The purpose of an implementation inspection is to determine that the necessary GLP quality systems have been established within the test facility and appear appropriate for the type of regulatory studies that will be conducted, and to confirm the suitability of the premises and laboratory facilities in which the studies will be conducted. Data and supporting records will be examined if any are available. After a satisfactory inspection the test facility will be accepted as a full member of the compliance programme; these new members will usually be re-inspected after approximately 12 months to confirm that the GLP systems are operating effectively.
- Compliance monitoring inspection: Test facilities that are members of the Compliance Programme will be subject to periodic inspections intended to verify that the principles of GLP are being complied with. These inspections will include a review of the GLP quality system elements, inspection of laboratory facilities and an audit of completed and on-going studies. The frequency and scope of these compliance monitoring inspections is determined by current risk assessment procedures, but most test facilities can expect to be inspected every 12 to 24 months.
- For cause inspections :These are inspections undertaken as a result of serious concerns relating to a test facility. These inspections might be to investigate allegations made by a whistleblower, to investigate possible fraud, or to provide regulatory oversight following serious non-compliance issues.
Study audits
In addition to GLP inspections, the GLP Monitoring Authority may be asked by another regulatory authority, either in the UK or overseas, to audit a particular study that has been submitted to them. The objectives of the audit are to answer specific questions raised by the authority that requested the audit and to undertake a detailed assessment of the study to determine the extent to which it complies with the principles of GLP.
While the focus of these audits is distinctly different to the three types of inspection detailed above, the process for conducting the audit is the same.
The inspection process
The major stages of the inspection process are:
- Notification: A test facility is normally given a minimum of ten working-days notice of an inspection, but there will be some circumstances in which the inspection may be unannounced or at short notice. The test facility may be requested to provide a dossier of information in advance of the inspection; this information is used to assist in the detailed planning of the inspection.
- The introductory or opening meeting: The purpose of the meeting is for the inspector to meet with key personnel from the test facility to discuss the arrangements for the inspection. The inspector will confirm the purpose and scope of the inspection.
- The site inspection: The purpose of the site inspection is to determine the degree to which operations are conducted in compliance with the GLP principles. To this end the inspector(s) will review documentation and records, and will visit all, or some of the laboratory areas. During these activities the inspector may interview the personnel responsible for the activity or facility being inspected. Any observations or deficiencies noted during the inspection would normally be discussed with the company representatives at the time.
- The summary or closing meeting: The purpose of the meeting is for the inspector to present a verbal summary of the inspection findings to test facility management and to allow them the opportunity to correct any misunderstandings. The inspector would also describe the post inspection activities that will follow.
- Definition of deficiencies: Adverse inspection findings are classified as critical deficiency, major deficiency or deficiency:
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- Critical deficiency: A deficiency which has resulted in the test facility or part thereof, or a study not being in compliance with the principles of GLP. A deficiency that indicates a significant risk that the test facility, or a part thereof, or a specific study will not be 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
- Deficiency: A departure from the principles of GLP which is not considered critical or major.
Post-inspection procedures
A post-inspection letter is sent to provide written confirmation of the deficiencies reported verbally at the closing meeting. Test facility management is asked to respond to the deficiencies raised, providing details, including timelines, of any corrective and remedial actions, implemented or proposed, to address the reported deficiencies and to prevent future recurrence.
This response is normally requested within 20 working days but following serious adverse inspection findings a shorter timeframe may be specified.
On receipt of this response, the inspector will consider whether the remedial actions that have been taken, or are proposed, adequately address the deficiencies raised. If the inspector is not satisfied with the response there will be further correspondence until all issues have been resolved.
Once the inspector is satisfied that any necessary remedial action has been taken, or is in hand, and that the test facility is now operating in compliance with GLP a Statement of GLP Compliance will be issued. It is at this point that a risk assessment will be conducted and the date and scope of the next compliance monitoring inspection will be determined.
Regulatory or enforcement action
If following an inspection or a study audit there are serious concerns relating to the GLP compliance of the test facility or of studies conducted within it, the GLPMA may exercise a range of sanctions including suspension of membership of the UK GLP Compliance Programme or disqualification of the GLP status of specified studies. The need for any such regulatory action is considered on a case by case basis. If an inspection has identified potential breaches of the GLP regulations, the matter will be referred to the MHRA Enforcement Group who will assume responsibility for the subsequent investigation and any resulting legal proceedings.
Collation and trending of deficiencies
Each individual deficiency raised as part of a UK facility inspection is entered into a database. The deficiencies are categorised based on their severity and the area of compliance to which they relate. This process allows the GLPMA to trend the findings identified in a given calendar year, which in turn can highlight common weaknesses and allow the GLPMA to focus on these areas and issue formal guidance documents where appropriate.
The annual deficiency report is presented each year at the Consultative Committee meeting and the presentation published here:
GLP Deficiency Data 2007 Annual Report
(68Kb)
GLP Deficiency Data 2008 Annual Report (98Kb)
GLP Deficiency Data 2009 Annual Report (65Kb)
GLP Deficiency Data 2010 Annual Report (70Kb)
