- batch
means a specific quantity or lot of a test or reference substance produced during a defined cycle of manufacture in such a way that it could be expected to be of a uniform character and should be designated as such;
- laboratory
means a test facility which conducts or which intends to conduct safety studies;
- monitoring authority
means any national authority which is responsible (either solely or jointly with other such authorities) for monitoring adherence to the principles of good laboratory practice;
- OECD
means the Organisation for Economic Co-operation and Development;
- principles of good laboratory practice
means the principles of good laboratory practice set out in Schedule 1 to these Regulations, which are based on the principles of good laboratory practice contained in Annex 2 to the Decision of the Council of the OECD of 12th May 1981 on the mutual acceptance of data for the evaluation of chemical products, read with the guidance on inspection procedures and study audits set out in Schedule 2 to these Regulations, which is based on Annex B of the GLP Inspection and Verification Directive;
- quality assurance programme
means an internal control system designed to ascertain that the safety study is in compliance with these principles of good laboratory practice;
- raw data
means all original laboratory records and documentation, or verified copies thereof, which are the result of the original observations and activities in a safety study;
- reference substance
means any well defined substance or any mixture other than the test substance used to provide a basis for comparison with the test substance;
- regulatory authority
means any national authority with legal responsibility for aspects of the control of chemicals;
- safety study
means a non-clinical experiment or set of experiments— (a) in which a substance is examined to evaluate its safety with respect to human health, animal health or the environment;
- sample
means any quantity of a test or reference substance;
- specimen
means any material derived from a test system for examination, analysis, or storage;
- sponsor
means a person or entity who commissions or pays for a safety study;
- standard operating procedures
means written procedures which describe how to perform certain routine laboratory tests or activities normally not specified in detail in study plans or test guidelines;
- study director
means the individual responsible for the overall conduct of the safety study;
- study plan
means a document which defines the entire scope of the safety study;
- test substance
means a substance or a mixture which is under investigation;
- test system
means any animal, plant, microbial, cellular, sub-cellular, chemical, or physical system or a combination thereof used in a safety study;
- the GLP Inspection and Verification Directive
means Council Directive 88/320/EEC of 9th June 1988 on the inspection and verification of Good Laboratory Practice (GLP), as amended by Commission Directive 90/18/EEC of 18th December 1989 adapting to technical progress the Annex to Council Directive 88/320/EEC on the inspection and verification of good laboratory practice (GLP);
- vehicle
means any agent which serves as a carrier used to mix, disperse, or solubilise the test or reference substance to facilitate the administration to the test system.