GLP Monitoring

If the test facility claims to be GLP-compliant but is located in a country where there is no authorised body responsible for GLP monitoring, i.e., a national GLP compliance program, the Study Director needs to be assured that the facility (including the archive, if used) does operate in compliance with GLP principles. This can be achieved by conducting a pre-study QA test site inspection or by a review of documentary evidence, e.g., notice of adverse findings and subsequent responses, or Establishment Inspection reports. The Study Director should ideally discuss the above with QA personnel and send copies of any documentary evidence used to the Quality Assurance Unit (QAU) for inclusion in the QA multi-site study file. 

The Department of Health has responsibility for the monitoring in the UK through the GLP Monitoring Authority. 

For ISO 9000 approval there are several certification bodies who register and certify companies meeting the requirements. In the UK such certification bodies must themselves be accredited by UKAS as competent to carry out certifications. For GLP. the GLP Monitoring Authority of the Medicines Control Agency issues a letter of compliance to an approved laboratory. This is restricted to laboratories carrying out safety studies as described above. However, any laboratory may state they work within the GLP guidelines. In the case of accreditation by UKAS, a Certificate of Accreditation is issued which relates to specific tests or calibrations. Laboratories will be included in UKAS s list of accredited laboratories, i.c. UKAS Directory of Accredited Labora-... 

U.K. DoH GLP Monitoring Unit publishes The Application of GLP Principles to Computer Systems... 

One year later the U.K. Department of Health (DoH) GLP Monitoring Unit pubhshed its expectation for computer systems in laboratories conducting human health and environmental safety studies.23 It identihes laboratory management responsibilities for ... 

Within OECD, the inspectors are also undertaking mutual joint visits to review all the national GLP-monitoring programs. Each country is visited by a team, comprising inspectors of three other countries, and the program, inspections, and on-site study audits done by the country which is visited are evaluated and discussed among the inspectors. 

While in other countries all aspects of GLP monitoring can be assembled under the roof of one single GLP Monitoring Authority, there are still others who make use of the possibility of combining GLP Compliance Monitoring further with the monitoring activities in the area of other quality systems, like accreditation or ISO. 

National) GLP Monitoring Authority A body established within a Member country with responsibility for monitoring the good laboratory practice compliance of test facilities within its territories and for discharging other such functions related to good laboratory practice as may be nationally determined. It is understood that more than one such body may be established in a Member country. 

Inspector A person who performs the test facility inspections and study audits on behalf of the (National) GLP Monitoring Authority. 

National) GLP Monitoring Authorities will have access to commercially valuable information and, on occasion, may even need to remove commercially sensitive documents from a test facility or refer to them in detail in their reports. 

Inspectors should have qualifications and practical experience in the range of scientific disciplines relevant to the testing of chemicals. (National) GLP Monitoring Authorities should ... 

While Inspectors will not normally wish to enter test facilities against the will of the facility s management, circumstances may arise where test facility entry and access to data are essential to protect public health or the environment. The powers available to the (National) GLP Monitoring Authority in such cases should be defined. 

Where no or where only minor deviations have been found, the (National) GLP Monitoring Authority may ... 

Where serious deviations are found, the action taken by (National) GLP Monitoring Authorities will depend upon the particular circumstances of each case and the legal or administrative provisions under which GLP Gompliance Monitoring has been established within their countries. Actions which may be taken include, but are not limited to, the following ... 

Problems, or differences of opinion, between Inspectors and test facility management will normally be resolved during the course of a Test Facility Inspection or Study Audit. However, it may not always be possible for agreement to be reached. A procedure should exist whereby a test facility may make representations relating to the outcome of a Test Facility Inspection or Study Audit for GLP Compliance Monitoring and/or relating to the action the GLP Monitoring Authority proposes to take thereon. 

National GLP monitoring authorities may request information relating to the nature and dates of Quality Assurance inspections. However, Quality Assurance inspection reports should not normally be examined for their contents by national monitoring authorities as this may inhibit Quality Assurance when preparing inspection reports. Nevertheless, national monitoring... 

A Test Facility Inspection of any large facility is likely to reveal a number of minor deviations from GLP Principles but, normally, these will not be sufficiently serious to affect the validity of studies emanating from that test facility. In such cases, it is reasonable for an Inspector to report that the facility is operating in compliance with GLP Principles according to the criteria established by the (National) GLP Monitoring Authority. Nevertheless, details of the inadequacies or faults detected should be provided to the test facility and assurances sought from its senior management that action will be taken to remedy them. The Inspector may need to revisit the facility after a period of time to verify that necessary action has been taken. 

If a serious deviation from the GLP Principles is identified during a Test Facility Inspection or Study Audit which, in the opinion of the Inspector, may have affected the validity of that study, or of other studies performed at the facility, the Inspector should report back to the (National) GLP Monitoring Authority. The action taken by that Authority and/or the Regulatory Authority, as appropriate, will depend upon the nature and extent of the non-compliance and the legal and/or administrative provisions within the GLP Gompliance Programme. 

Where a Study Audit has been conducted at the request of a Regulatory Authority, a full report of the findings should be prepared and sent via the relevant (National) GLP Monitoring Authority to the Regulatory Authority concerned. 

Number 2 (Revised) Guidance for GLP Monitoring Authorities, Revised Guides for Compliance Monitoring Procedures for Good Laboratory Practice, Paris 1995... 

Having made these suggestions, it is a GLP requirement that the testing of these materials is performed according to GLP or an equivalent standard (see discussion previously). Facilities directly responsible for the toxicology studies or supporting those studies will be audited by the national or other interested GLP monitoring authority. Some national authorities will audit the test facility for the test article analysis. 

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