The Good Laboratory Practice Regulations 1999

Made: 18th November 1999

Laid before Parliament: 19th November 1999

Coming into force: 14th December 1999

The Secretary of State, being a Minister designated for the purposes of section 2(2) of the European Communities Act 1972 in relation to measures relating to good laboratory practice, in exercise of the powers conferred by the said section 2(2), and of all other powers enabling him in that behalf, hereby makes the following Regulations—

Citation and commencement

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These Regulations may be cited as the Good Laboratory Practice Regulations 1999 and shall come into force on 14th December 1999.

Interpretation

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• (1) In these Regulations, unless the context otherwise requires—

• “batch" 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;

• “experimental starting date" means the date on which the first study specific data are collected;

• “experimental completion date" means the last date on which data are collected from the study;

• “good laboratory practice instrument" means a document which comprises, or includes—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;a statement by a monitoring authority on the level of adherence of a test facility or a test site to the principles of good laboratory practice (including a statement that the facility or site has been found to be operating in compliance with the said principles or with these Regulations);a statement by any other person for submission, or which may be submitted, to a regulatory authority on the level of adherence of a test facility or test site, or any part of a test facility or test site, to the principles of good laboratory practice (including a statement that the facility or site operates in compliance with the said principles or with these Regulations);a statement by any person for submission, or which may be submitted, to a regulatory authority that he is a member of the United Kingdom good laboratory practice compliance programme;a report issued by a monitoring authority as a result of a study audit or a test facility or test site inspection;a statement by any person for submission, or which may be submitted, to a regulatory authority about the level of adherence of a regulatory study, or any phase of a regulatory study, to the principles of good laboratory practice (including a statement that the study, or phase of a study, was conducted in compliance the said principles or with these Regulations),and for the purposes of this definition, the “principles of good laboratory practice" means the said principles howsoever described;

• “master schedule" means a compilation of information to assist in the assessment of workload and for the tracking of studies at a test facility;

• “monitoring authority" 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;

• “OECD" means the Organisation for Economic Co-operation and Development;

• “OECD test guideline" means a test guideline which the OECD has recommended for use in its member countries;

• “operator", in relation to a test facility, means the person having control of the test facility;

• “premises", in relation to a test facility, includes field sites at which phases of regulatory studies are conducted;

• “principal investigator" 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;

• “principles of good laboratory practice” means—the principles of good laboratory practice set out in Schedule 1, which are based on the Good Laboratory Practice Principles set out in Section II of Annex I to the European Parliament and Council Directive 2004/10/EC on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances; read withthe revised guidance for the conduct of test facility inspections and study audits set out in Schedule 2, which is based on part of the Revised Guidance for the Conduct of Test Facility Inspections and Study Audits in Annex I to the European Parliament and Council Directive 2004/9/EC on the inspection and verification of good laboratory practice;

• “quality assurance programme" 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;

• “raw data" 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;

• “reference item" means any article used to provide a basis for comparison with a test item;

• “regulatory authority" 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;

• “regulatory study" means a non-clinical experiment or set of experiments—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;the results of which are, or are intended, for submission to the appropriate regulatory authorities; and in respect of which compliance with the principles of good laboratory practice is required in respect of that experiment or set of experiments by the appropriate regulatory authorities (whether or not compliance with the said principles in respect of that experiment or set of experiments is also a legislative requirement);

• “short-term study" means a regulatory study of short duration with widely used, routine techniques;

• “specimen" means any material derived from a test system for examination, analysis, or retention;

• “sponsor" means a person who commissions, supports and/or submits a regulatory study;

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

• “study completion date" means the date the study director signs the final report;

• “study director" means the individual responsible for the overall conduct of the regulatory study;

• “study initiation date" means the date the study director (first) signs the study plan;

• “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;

• “study plan amendment" means an intended change to the study plan after the study initiation date;

• “study plan deviation" means an unintended departure from the study plan after the study initiation date;

• “test facility" means a facility which conducts or intends to conduct regulatory studies;

• “test item" means an article that is the subject of a regulatory study;

• “test site" means a location at which a phase of a regulatory study is conducted;

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

• “vehicle" 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.

• (2) In these Regulations, unless the context otherwise requires, a reference—

• (a) to a numbered regulation or Schedule is to the regulation in or Schedule to these Regulations bearing that number;

• (b) in a regulation to a numbered or lettered paragraph is to the paragraph of that regulation bearing that number or letter; and

• (c) in a paragraph to a numbered or lettered sub-paragraph is to the sub-paragraph in that paragraph bearing that number or letter.

The Good Laboratory Practice Monitoring Authority

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• (1) The body responsible for enforcing compliance with these Regulations shall be the Good Laboratory Practice Monitoring Authority, a body consisting 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.

• (2) The functions of the Good Laboratory Practice Monitoring Authority may be performed by any one of the Secretary of State for Health and Social Care, the National Assembly for Wales, the Scottish Ministers or the Department of Health and Social Services for Northern Ireland acting alone, or any two or more of them acting jointly.

• (3) In accordance with the preceding provisions of this regulation, in these Regulations, “the Good Laboratory Practice Monitoring Authority" (“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).

• (4) The GLPMA may appoint such persons as they think necessary for the proper discharge by them of their functions, and those persons shall be appointed upon such terms and conditions (including conditions as to remuneration, benefits, allowances and reimbursement for expenses) as the GLPMA think fit.

Requirement to be a member or a prospective member of the United Kingdom good laboratory practice compliance programme

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A regulatory study shall not be conducted at any premises of a test facility unless—

• (a) the operator of the test facility is regarded by virtue of regulation 5 or 6 as a member or a prospective member of the United Kingdom good laboratory practice compliance programme (hereafter referred to as “the UK GLP compliance programme"); and

• (b) the operator’s membership or prospective membership of that programme is or is partly in respect of those premises,

and if a regulatory study is conducted at any premises in contravention of this regulation, the operator of that test facility shall be guilty of an offence.

Prospective membership of the United Kingdom good laboratory practice compliance programme

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• (1) An operator of a test facility shall, for the purposes of these Regulations, be regarded as being a prospective member of the UK GLP compliance programme in respect of particular premises only if—

• (a) he has informed the GLPMA by notice in writing of the intention to conduct regulatory studies at those premises;

• (b) the GLPMA has in writing—

• (i) acknowledged receipt of that notification, and

• (ii) informed the operator that he is a prospective member of the programme in respect of those premises,

and he has not ceased to be regarded as a prospective member of the programme in respect of those premises by virtue of paragraph (2).

• (2) An operator of a test facility shall cease to be regarded as a prospective member of the UK GLP compliance programme in respect of particular test facility premises if—

• (a) he is admitted to membership of the programme in respect of those premises by the GLPMA;

• (b) he informs the GLPMA in writing that he no longer conducts or intends to conduct regulatory studies at those premises; or

• (c) subject to paragraph (3), the GLPMA inform him in writing that they are not prepared to admit him to membership of the programme in respect of those premises.

• (3) The GLPMA shall, before informing a prospective member of the UK GLP compliance programme they are not prepared to admit him to membership of the programme in respect of particular test facility premises—

• (a) inform the prospective member that they are considering taking such action and explain to him in writing the reasons why such action is being considered;

• (b) give the operator a specified period within which to make representations to the GLPMA; and

• (c) consider any representations which are duly made and not withdrawn,

unless, for either of the reasons set out in paragraph (4), it is necessary for the GLPMA to inform the prospective member immediately that they are not prepared to admit him to membership of the programme in respect of those premises.

• (4) The reasons referred to in paragraph (3) are ...—

• (a) there is a failure to adhere to the principles of good laboratory practice at those premises which, in the opinion of the GLPMA, may contribute towards precipitating a danger to animal or human health or to the environment; ...

• (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Membership of the United Kingdom good laboratory practice compliance programme

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• (1) Subject to paragraph (2) and except where paragraph (5), (6) or (7) applies, the operator of a test facility shall be regarded as being a member of the UK GLP compliance programme in respect of particular test facility premises if—

• (a) he was regarded as being a member of the programme in respect of those premises immediately before these Regulations come into force by virtue of regulation 6 of the Good Laboratory Practice Regulations 1997 ; or

• (b) after having inspected those premises, the GLPMA have informed the operator in writing that they are admitting the operator to membership of the programme in respect of those premises.

• (2) The operator of a test facility shall cease to be a member of the UK GLP compliance programme in respect of particular test facility premises if—

• (a) he has informed the GLPMA in writing that regulatory studies are no longer conducted at those premises; or

• (b) membership of the programme in respect of those premises has been withdrawn by the GLPMA in accordance with paragraph (3).

• (3) Subject to paragraph (4), the GLPMA may by a notice in writing served on the operator of a test facility withdraw the operator’s membership of the UK GLP compliance programme in respect of particular test facility premises if—

• (a) the operator, in the opinion of the GLPMA, no longer intends to conduct regulatory studies at those premises;

• (b) the operator is, in the opinion of the GLPMA, not capable of ensuring that the principles of good laboratory practice are adhered to at those premises; or

• (c) at those premises there is a failure to adhere to the principles of good laboratory practice which, in the opinion of the GLPMA, may contribute towards precipitating a danger to animal or human health or to the environment.

• (4) Before serving a notice on an operator of a test facility under paragraph (3)(a) or (b), the GLPMA shall—

• (a) inform the operator in writing that they are considering serving such a notice and explain to him in writing the reasons why they are considering serving such a notice;

• (b) give the operator a specified period within which to make representations to him; and

• (c) consider any representations which are duly made and not withdrawn.

...

• (5) Where an operator of a test facility has ceased to be a member of the UK GLP compliance programme in respect of particular test facility premises on the grounds set out in paragraph (2)(a), or membership of the programme in respect of particular test facility premises has been withdrawn from him on the grounds set out in paragraph (3)(a), he shall again be regarded as being a member of the programme in respect of those premises if—

• (a) he has informed the GLPMA by notice in writing of the intention to conduct further regulatory studies at those premises;

• (b) he has become a prospective member of the programme in respect of those premises in accordance with the procedure set out in regulation 5; and

• (c) after having inspected those premises, the GLPMA has informed the operator in writing of his readmission to membership of the programme in respect of those premises.

• (6) Where membership of the UK GLP compliance programme has been withdrawn from an operator of a test facility in respect of particular test facility premises on the grounds set out in paragraph (3)(b), he shall again be regarded as being a member of the programme in respect of those premises if—

• (a) he has informed the GLPMA by notice in writing of the intention to conduct further regulatory studies at those premises; and

• (b) the GLPMA—

• (i) are of the opinion that the operator is capable of ensuring that the principles of good laboratory practice are adhered to at those premises, and

• (ii) have informed the operator in writing of his readmission to membership of the programme in respect of those premises.

• (7) Where membership of the UK GLP compliance programme has been withdrawn from an operator of a test facility in respect of particular test facility premises on the grounds set out in paragraph (3)(c), he shall again be regarded as being a member of the programme in respect of those premises if—

• (a) he has informed the GLPMA by notice in writing of the intention to conduct further regulatory studies at those premises; and

• (b) the GLPMA—

• (i) are of the opinion that the possible danger to animal or human health or to the environment which led to membership being withdrawn is no longer present, and

• (ii) have informed the operator in writing of his readmission to membership of the programme in respect of those premises.

Requirement to adhere to the principles of good laboratory practice

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• (1) No person shall conduct a regulatory study at any premises of a test facility unless with regard to that study the principles of good laboratory practice are adhered to—

• (a) as respects the organisational structure surrounding the study; and

• (b) as respects the conditions under which the study is planned, performed, monitored, recorded, archived and reported.