Test facility inspection:

The notified body as referred to under point 3.1 must have permanent access for inspection purposes to the locations of building sites, production workshops, locations of assembling and installation, storage areas and, where appropriate, prefabrication or testing facilities and, more general, to all premises which it considers necessary for its task, in accordance with the applicant's specific contribution to the subsystem project.

The notified body(ies) as referred to under point 3.1 must have permanent access for inspection purposes to the locations of design, building sites, production workshops, locations of assembling and installation, storage areas and, where appropriate, prefabrication or testing facilities and, more general, to all premises which it considers necessary for its task, in accordance with the applicant's specific contribution to the subsystem project.

make an initial determination as to the parts of the facility to be covered during the test facility inspection,

Test facilities can freely dispose of the reports of test facility inspection and study audits that concern them.

Test Facility Inspections

Test facility inspections

describe the test facility inspection and study audit procedures for verification of GLP compliance.

Prior to conducting a test facility inspection or study audit, inspectors should familiarise themselves with the facility which is to be visited.

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.

If a test facility inspection or study audit reveals only minor deviations from GLP principles, the facility should be required to correct such minor deviations.

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.

Before proceeding further with a test facility inspection, it is advisable for the inspector(s) to establish contact with the facility's quality assurance (QA) unit.

The administrative and practical details of a test facility inspection or study audit should be discussed with the management of the facility at the start of the visit.

When a test facility inspection or study audit has been completed, the inspector should be prepared to discuss his findings with representatives of the test facility at a closing conference and should prepare a written report, i. e., the inspection report.

These inspections include both a general test facility inspection and a study audit of one or more on-going or completed studies;

When a test facility inspection or study audit has been completed, the inspector should prepare a written report of the findings.

In cases where particular documents or records are to be examined, it may be useful to identify these to the test facility in advance of the visit so that they will be immediately available during the test facility inspection.

Member States should take action where deviations from GLP principles are found during or after a test facility inspection or study audit.

to inform the management and staff of the facility of the reason for the test facility inspection or study audit that is about to take place, and to identify the facility areas, study(ies) selected for audit, documents and personnel likely to be involved.

Each Party may request further test facility inspection or study audits if there is a documented doubt as to whether a test was conducted in accordance with Good Laboratory Practice.

provision for test facility inspections.

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.

A test facility inspection will usually include a study audit or review as a part of the inspection, but study audits will also have to be conducted from time to time at the request, for example, of a Regulatory Authority.

The Parties shall supply each other with any additional information on a test facility inspection or study audit in response to a reasonable request from the other Party.

In each section, there is a statement of purpose, as well as an illustrative list of specific items which could be considered during the course of a test facility inspection.

Each Contracting Party may request further test facility inspection or study audits on the other party's territory if there is a documented doubt as to wheter a test was conducted in accordance with good laboratory practice.

The Contracting Parties shall supply each other with any necessary additional information on a test facility inspection or study audit in response to a reasonable request from the other party.

If in exceptional cases doubts persist and the requesting party can justify a special concern, and with the consent of the test facility concerned, it may designate one or more expets of its authorities to participate in a test facility inspection or the audit of a study conducted by the authorities of the other party.

Follow-up to test facility inspections and study audits

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.

Test facility inspections and study audits inevitably disturb the normal work in a facility.

provide information on categories of test facility inspections/study audits.

REVISED GUIDANCE FOR THE CONDUCT OF TEST FACILITY INSPECTIONS AND STUDY AUDITS

describe the documentation which will be required for the test facility inspection, such as lists of on-going and completed studies, study plans, standard operating procedures, study reports, etc. Access to and, if necessary, arrangements for the copying of relevant documents should be agreed on at this time,

- the provisions regarding test facility inspection and study audits shall be in conformity with those adopted by the Council of the OECD in Annexes I to III to the 1989 Decision-Recommendation (C(89)87(final)), that has been modified by its Decision-Recommendation of 9 March 1995 (C(95)8(final)), and all amendments made thereto,

describe actions that may be taken as follow-up test facility inspections and study audits.

Inspectors should note, in particular, any deficiencies from previous test facility inspections.

The date of the inspections and, if appropriate, the categories of test inspected in the test facility at that time should be included.

Test facility inspections will generally include, inter alia, study audits, which review on-going or completed studies.

It is principally concerned with test facility inspections, an activity which occupies much of the time of GLP inspectors.

a person who performs the test facility inspections and study audits on behalf of the (national) GLP Monitoring Authority,

Test facility inspections should be conducted on a regular, routine basis to establish and maintain records of the GLP compliance status of test facilities.

the periodic inspection of test facilities and/or auditing of studies for the purpose of verifying adherence to GLP principles,

suspension of test facility inspections or study audits of a test facility and, for example and where administratively possible, removal of the test facility from the (national) GLP compliance programme or from any existing list or register of test facilities subject to GLP test facility inspections,

Where no previous test facility inspections have been conducted, a pre-inspection visit can be made to obtain relevant information.

employed on contract, or in another way, by the (national) GLP Monitoring Authority to perform test facility inspections or study audits.

Specific study audits are also often requested by Regulatory Authorities, and can be conducted independently of test facility inspections.

Inspectors will, while conducting test facility inspections and study audits, have access to confidential, commercially valuable information.

Each Contracting Party may, on request, participate as an observer in an inspection of a test facility conducted by the autorities of the other party with the consent of the test facility concerned in order to maintain a continuing understanding of the other party's inspection procedures.