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

The Parties mutually accept the conclusions of study audits and test facility inspections performed by the monitoring authorities referred to in Section III

The Parties mutually accept the conclusions of study audits and test facility inspections performed by the monitoring authorities referred to in section III.

Based on Article 9 of the Agreement, each Party may, on request, participate as an observer in an inspection of a test facility conducted by the authorities 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.

The reports of these inspections will be sent by the inspectors to the test facility concerned and, in addition, to the authorities of the Contracting Parties ( fn ),

During inspections, the management structures and operational procedures of the test facility are examined, key technical personnel are interviewed, and the quality and integrity of data generated by the facility are assessed and reported,

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.

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,

inspections will start as soon as possible after the signature of the Agreement and on request of the Israeli Authorities, in order to inspect the test facilities interested to be GLP recognised,

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,

(d) encouraging, promoting and otherwise facilitating cooperation between the Parties' organisations, public and/or private, for metrology, standardisation, testing, certification, inspection and accreditation; and

the requesting party shall not be obliged to accept the data generated by the test facility concerned from the date on which the request is made, until the results of the further inspection or study audit conducted by the competent authority of the requested party have re-confirmed the compliance of the test facility with the principles of GLP;

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.

ensure that, unless all commercially sensitive and confidential information has been excised, reports of test facility inspections and study audits are made available only to Regulatory Authorities and, where appropriate, to the test facilities inspected or concerned with study audits and/or to study sponsors.

In the latter two cases, the (national) GLP Monitoring Authority should have ultimate responsibility for determining the GLP compliance status of test facilities and the quality/acceptability of a study audit, and for taking any action based on the results of test facility inspections or study audits which may be necessary.

The Contracting Parties shall ensure that, unless all commercially sensitive and confidential information has been excised, reports of test facility inspections and study audits are made available only to regulatory authorities and, where appropriate, to the test facilities inspected or concerned with study audits and/or to study sponsors.

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 Contracting Parties shall provide each other promptly with the information referred to in paragraph 1 about test facilities that in the light of the results of the inspections and study audits conform to good laboratory practice but have yet not been included in the list referred to in that paragraph.

In accordance with Article 12 of this Agreement, the Parties in particular provide each other at least annually with a list of the test facilities 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.

(a) Each party may request the other party, by indicating in writing a reasoned doubt on whether a study was conducted in accordance with the principles of GLP, to conduct further inspections or study audits on a confirmed test facility, in accordance with the applicable laws, regulations and administrative provisions of that other party;

The notified body as referred to in 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.

(1) Following inspections carried out by designated EC inspectors between 28 March 1996 and 1 January 2000, in accordance with Article 12 of the Agreement on mutual recognition of OECD principles of good laboratory practice (GLP) and compliance monitoring programmes between the European Community and the State of Israel, five Israeli test facilities were found to be in compliance with GLP requirements in their respective areas of expertise.

The notified body(ies) as referred to in 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.

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.

'verification' means the monitoring of the compliance of a test facility with the principles of GLP by procedures such as study audits and inspections that are set out in the laws, regulations and administrative provisions of each party specified in Section III of Part B of this Sectoral Annex and that are consistent with the OECD Council Decision - Recommendation of 2 October 1989 (C(89) 87(final)), and in particular its Annexes I and II, as amended by the OECD Council Decision of 9 March 1995 (C(95)8(final)).

The provisions for the inspection and verification of GLP which are contained in parts A and B are those contained in Annexes I (Guides for compliance monitoring procedures for good laboratory practice) and II (Guidance for the conduct of test facility inspections and study audits) respectively of the OECD Council Decision-Recommendation on compliance with principles of good laboratory practice [C(89)87(Final)] of 2 October 1989 as revised by the OECD Council Decision amending the Annexes to the Council Decision-Recommendation on compliance with principles of good laboratory practice of 9 March 1995 [C(95)8(Final)].

test facility inspection:

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.

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.

have access to appropriate administrative, inspection and testing facilities, tools and equipment, as specified in paragraph 3,

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

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

whereas, in order to facilitate the mutual recognition of inspection procedures, harmonized Community procedures should be set up and the criteria for appointing the bodies responsible for carrying out tests, surveillance and verification should be harmonized;

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.

"verification" means the monitoring of the compliance of a test facility with the principles of GLP by procedures such as study audits and inspections that are set out in the laws, regulations and administrative provisions of each party specified in Section III of Part B of this Sectoral Annex and that are consistent with the OECD Council Decision - Recommendation of 2 October 1989 (C(89) 87(final)), and in particular its Annexes I and II, as amended by the OECD Council Decision of 9 March 1995 (C(95)8(final)).

The provisions for the inspection and verification of GLP which are contained in Parts A and B are those contained in Annexes I (Guides for compliance monitoring procedures for good laboratory practice) and II (Guidance for the conduct of test facility inspections and study audits) respectively of the OECD Council Decision-Recommendation on compliance with principles of good laboratory practice (C(89)87(Final)) of 2 October 1989 as revised by the OECD Council Decision amending the Annexes to the Council Decision-Recommendation on compliance with principles of good laboratory practice of 9 March 1995 (C(95)8(Final)).

encouraging, promoting and otherwise facilitating cooperation between the Parties' organisations, public and/or private, for metrology, standardisation, testing, certification, inspection and accreditation; and

Following inspections carried out by designated EC inspectors between 28 March 1996 and 1 January 2000, in accordance with Article 12 of the Agreement on mutual recognition of OECD principles of good laboratory practice (GLP) and compliance monitoring programmes between the European Community and the State of Israel, five Israeli test facilities were found to be in compliance with GLP requirements in their respective areas of expertise.