The Good Laboratory Practice Regulations 1999

means a specific quantity or lot of a test or reference item produced during a defined cycle of manufacture in such a way that it could be expected to be of a uniform character;

means the last date on which data are collected from the study;

means the date on which the first study specific data are collected;

means a document which comprises, or includes— (a) an endorsement by a monitoring authority of a claim by a test facility that the tests that it carries out comply with the principles of good laboratory practice;

means a compilation of information to assist in the assessment of workload and for the tracking of studies at a test facility;

means an authority in any country or territory which is responsible (either solely or jointly with other such authorities) for monitoring the good laboratory practice compliance of test facilities;

means the Organisation for Economic Co-operation and Development;

means an individual who, for a multi-site regulatory study, acts on behalf of the study director and has defined responsibility for one or more delegated phases of the study;

means the said principles howsoever described;

means a defined system, including personnel, which is independent of study conduct and is designed to assure test facility management of compliance with the principles of good laboratory practice;

means all original test facility records and documentation, or verified copies thereof, which are the result of the original observations and activities in a regulatory study;

means any article used to provide a basis for comparison with a test item;

means any authority in any country or territory with legal responsibility for aspects of the control of chemicals or items of natural or biological origin;

means a non-clinical experiment or set of experiments— (a) in which an item is examined under laboratory conditions or in the environment in order to obtain data on its properties or its safety (or both) with respect to human health, animal health or the environment;

means a regulatory study of short duration with widely used, routine techniques;

means any material derived from a test system for examination, analysis, or retention;

means a person who commissions, supports and/or submits a regulatory study;

means the documented procedures which describe how to perform tests or activities normally not specified in detail in study plans or test guidelines;

means the date the study director signs the final report;

means the individual responsible for the overall conduct of the regulatory study;

means the date the study director (first) signs the study plan;

means a document which defines the objectives and experimental design for the conduct of a regulatory study, and includes any study plan amendments;

means an intended change to the study plan after the study initiation date;

means an unintended departure from the study plan after the study initiation date;

means a facility which conducts or intends to conduct regulatory studies;

means an article that is the subject of a regulatory study;

means a location at which a phase of a regulatory study is conducted;

means any biological, chemical or physical system or a combination thereof used in a regulatory study;

(“the GLPMA") means any one or more of the Secretary of State for Health and Social Care, the National Assembly for Wales, the Scottish Ministers and the Department of Health and Social Services for Northern Ireland, and, in the case of anything falling to be done by the GLPMA, means any one or more of them acting as mentioned in paragraph (2).

means any agent which serves as a carrier used to mix, disperse, or solubilise the test or reference item to facilitate the administration or application to the test system.