The competent authority of the Member State concerned shall ensure, by means of repeated inspections, and if necessary unannounced inspections, and, where appropriate, by asking an Official Medicines Control Laboratory or a laboratory designated for that purpose to carry out tests on samples, that the legal requirements governing medicinal products are complied with.

inspect the manufacturing or commercial establishments of manufacturers of medicinal products or of active substances used as starting materials, and any laboratories employed by the holder of the manufacturing authorisation to carry out checks pursuant to Article 20;

The competent authority of the Member State concerned shall ensure, by means of repeated inspections and, if necessary, unannounced inspections, and where appropriate, by asking an Official Medicines Control Laboratory or a laboratory designated for that purpose to conduct tests on samples, that the legal requirements relating to veterinary medicinal products are complied with.

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.

Test facility inspection:

Test facility inspections

provision for test facility inspections.

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

Follow-up to test facility inspections and study audits

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

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

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

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

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

Council Directive 88/320/EEC of 9 June 1988 on the inspection and verification of Good Laboratory Practice (GLP)

They result in reports which describe the degree of adherence of a test facility to the GLP principles.

issue a statement that the test facility has been inspected and found to be operating in compliance with GLP principles.

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

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

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

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

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.

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.

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

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

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

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.

adapting to technical progress for the second time the Annex to Council Directive 88/320/EEC on the inspection and verification of good laboratory practice (GLP)

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.

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

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

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

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

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

it must have been submitted, at least once per year, to a clinical inspection and the taking of samples to be tested for the pathogens in question in an approved laboratory;

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

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.

Inspections for compliance with GLP principles may take place in any test facility generating health or environmental safety data for regulatory purposes.

The Contracting Parties shall provide each other at least annually with a list of the test facilities on their territory, which in the light of the results of the inspections and study audits conform to good laboratory practice, as well as of the dates of inspection or audit and their compliance status.

The purpose of this part of the Annex is to provide guidance for the conduct of test facility inspections and study audits which would be mutually acceptable to OECD member countries.

Council Directive 88/320/EEC of 9 June 1988 on the inspection and verification of good laboratory practice (GLP) (OJ No L 145, 11.6.1988, p. 35), as amended by:

provisions for special test facility inspections/study audits at the request of a Regulatory Authority, for example, prompted by a query arising from the submission of data to a Regulatory Authority,

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.

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 particular scheme established by a Member State to monitor good laboratory practice compliance by test facilities within its territories, by means of inspections and study audits,

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.

Test facility inspections are conducted to determine the degree of conformity of test facilities and studies with GLP principles and to determine the integrity of data to assure that resulting data are of adequate quality for assessment and decision-making by national Regulatory Authorities.

Commission Directive 1999/12/EC of 8 March 1999 adapting to technical progress for the second time the Annex to Council Directive 88/320/EEC on the inspection and verification of good laboratory practice (GLP) (Text with EEA relevance)

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.