ANNEX I U.K.

PART A U.K. REVISED GUIDES FOR COMPLIANCE MONITORING PROCEDURES FOR GLP

Definitions of terms U.K.

The definitions of terms in the OECD principles of good laboratory practice adopted in Article 1 of Directive 2004/10/EC of the European Parliament and of the Council are applicable to this part of this Annex. In addition, the following definitions apply:

— GLP principles

:

principles of good laboratory practice that are consistent with the OECD principles of good laboratory practice as adopted in Article 1 of Directive 2004/10/EC,

— GLP compliance monitoring

:

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

— (national) GLP compliance programme

:

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,

— (national) GLP Monitoring Authority

:

a body established within a Member State with responsibility for monitoring the GLP compliance of test facilities within its territories and for discharging other such functions related to GLP as may be nationally determined. It is understood that more than one such body may be established in a Member State,

— test facility inspection

:

an on-site examination of the test facility's procedures and practices to assess the degree of compliance with GLP principles. 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,

— study audit

:

a comparison of raw data and associated records with the interim or final report in order to determine whether the raw data have been accurately reported, to determine whether testing was carried out in accordance with the study plan and standard operating procedures, to obtain additional information not provided in the report, and to establish whether practices were employed in the development of data that would impair their validity,

— inspector

:

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

— GLP compliance status

:

the level of adherence of a test facility to the GLP principles as assessed by the (national) GLP Monitoring Authority,

— Regulatory Authority

:

a national body with legal responsibility for aspects of the control of chemicals.