study audit:

Study audit:

- data and assessments from comparable cases of already implemented global assessments or environmental impact assessments or other technical material containing data and assessments suitable for a global assessment (e.g. a study of the vulnerability of an area);

A ` Project Preparation Facility` provides financial support for the preparation of the Final Project Proposals (e.g. feasibility studies, environmental impact assessments, etc.).

The Final Project Proposal shall be accompanied by all necessary documents (e.g. feasibility study, Project document, environmental impact study) to allow a thorough appraisal.

External evaluation of applications through the establishment each year of academic review panels for the purpose of evaluating the merits of each study, research and lecturing proposal for further consideration by interview panels and the Committee;

` feasibility study` means the study before designing of the gas pipeline, carried out by the founders with a view to determine technical, environmental, economic and financial feasibility of the construction of the gas pipeline and/or assess the viability of utilisation of the existing gas pipeline for the implementation of the project.

(2) The Minister shall give consent on the basis of a comprehensive assessment of the environmental impact.

11. the details of the content and the methodology for the preparation of the comprehensive environmental impact assessment (4. paragraph of the article 54.);

(4) The detailed content and methodology for the preparation of a comprehensive environmental impact assessment shall be prescribed by the Minister in cooperation with the Ministers cited in the preceding paragraph.

The Conference notes that the Commission undertakes to prepare environmental impact assessment studies when making proposals which may have significant environmental implications.

promoting the collection, dissemination, analysis and improvement of statistics disaggregated by sex and age, development and dissemination of methodologies, guidelines, ex-ante and ex-post gender impact assessments, thematic studies, qualitative and quantitative indicators, and other operational instruments;

Study audits

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

When conducting a study audit, the inspector should:

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.

the requested party shall inform the requesting party of the results of the inspections or study audits, or provide an explanation why such an inspection or study audit has not been carried out;

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.

Completion of inspection or study audit

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.

CVs of personnel involved in the type(s) of studies selected for the study audit,

General guidance for the conduct of study audits will be found at the end of this Annex.

list(s) of the study directors and sponsors associated with the study(ies) being audited.

describe the documents and specimens that will be needed for on-going or completed study(ies) selected for study audit,

Follow-up to test facility inspections and study audits

specific SOPs as related to the studies or procedures being inspected or audited,

provide the Regulatory Authority which requested a study audit with a detailed report of the findings.

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.

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

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

Reports of pharmaco-kinetic and initial tolerability studies in healthy subjects and in patients, reports of pharmaco-kinetic studies to assess effects of intrinsic and extrinsic factors, and reports of population pharmaco-kinetic studies shall be provided.

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.

Other governments and intergovernmental organisations which express an interest may be informed of the studies made and of the results of discussions as thought fit.

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

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.

maintain records of test facilities inspected (and their GLP compliance status) and of studies audited for both national and international purposes.

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.

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

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.

In some cases, inspectors may need assistance from other experts in order to conduct an effective study audit, for example, where there is a need to examine tissue sections under the microscope.

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.