# The Good Laboratory Practice Regulations 1997, Regulation 9: Powers and duties of inspectors


(1) The Secretary of State may arrange for the discharge of any of his functions under regulation 3 by an inspector duly appointed in accordance with regulation 10.
(2) In enforcing compliance with these Regulations, a duly appointed inspector shall, on production, if required, of his credentials, have a right—
(a) at any reasonable hour to enter any premises other than premises used only as a private dwelling house which he has reason to believe it is necessary for him to visit for the purposes of enforcing compliance with these Regulations;
(b) to carry out on those premises during that visit such inspections, examinations, tests and analyses as he considers necessary for the purpose of establishing whether or not these Regulations are being complied with;
(c) to require the production of and take, without payment, samples of any substances on the premises for the purpose of establishing whether or not these Regulations are being complied with, but where an inspector takes a sample pursuant to this sub-paragraph, he shall give a portion of it, noted in a manner sufficient to identify it, to a responsible person at the premises;
(d) to require the production of, inspect and take copies of or extracts from any book, document, data or record (in whatever form it is held) which may be relevant in relation to the proper exercise by the inspector of his powers to enforce compliance with these Regulations;
(e) subject to paragraphs (6) and (7), to take possession of any books, documents, data, records (in whatever form they are held), articles or substances which are on the premises and which may be relevant in relation to the proper exercise by the inspector of his powers under these Regulations, and to detain them for as long as he considers necessary for the purposes of the proper exercise of those powers;
(f) to question any person whom he finds on the premises and whom he has reasonable cause to believe is able to give him information which is relevant to the proper exercise by the inspector of his powers under these Regulations;
(g) to require any person to afford him such facilities and assistance with respect to any matter within that person’s control or in relation to which that person has responsibilities as are necessary in order to enable the inspector to establish whether or not these Regulations are being complied with;
(h) to exercise any of the functions of the Secretary of State arising out of or related to his responsibility for assessing compliance with the principles of good laboratory practice under or by virtue of these Regulations,
but nothing in this paragraph shall be taken to compel the production by any person of a document of which he would, on grounds of legal professional privilege, be entitled to withhold production on an order for discovery in an action in the High Court or, as the case may be, on an order for the production of documents in an action in the Court of Session.
(3) If a justice of the peace is satisfied by any written information on oath that there are reasonable grounds for entry into any premises other than premises used only as a private dwelling house for any purpose mentioned in paragraph (1), and—
(a) admission to the premises has been or is likely to be refused and that notice of intention to apply for a warrant under this subsection has been given to the occupier; or
(b) that an application for admission, or the giving of such notice, would defeat the object of the entry or that the premises are unoccupied or that the occupier is temporarily absent and it might defeat the object of the entry to await his return,
the justice may by warrant signed by him, which shall continue in force for a period of one month, authorise any duly appointed inspector to enter the premises, if need be by force.
(4) An officer entering any premises by virtue of paragraph (2) or of a warrant under paragraph (3) may take with him when he enters those premises such equipment as may appear to him necessary and any person who is authorised by the Secretary of State to accompany him on that visit.
(5) On leaving any premises which an inspector is authorised to enter by a warrant under paragraph (3), that inspector shall, if the premises are unoccupied or the occupier is temporarily absent, leave the premises as effectively secured against trespassers as he found them.
(6) Where, pursuant to paragraph (2)(e), an inspector takes possession of any book, document, data, record, article or substance, he shall leave on the premises with a responsible person a statement giving particulars of the book, document, record, data, article or substance sufficient to identify it and stating that he has taken possession of it.
(7) Before taking possession of any substance pursuant to paragraph (2)(e), an inspector shall, where it is reasonably practicable to do so, take a sample of it pursuant to paragraph (2)(c).
(8) In enforcing compliance with these Regulations, the Secretary of State or a duly appointed inspector shall have regard to any relevant provision of—
(a) the guides for compliance monitoring procedures for good laboratory practice set out in Annex A to the GLP Inspection and Verification Directive; and
(b) the guidance for the conduct of laboratory inspections and study audits set out in Annex B to that Directive.

---
Source: https://www.legislation.gov.uk/uksi/1997/654/regulation/9 (the official version)
Page: https://openlegislation.uk/good-laboratory-practice-regulations-1997/regulation-9
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.