The Good Laboratory Practice Regulations 1997

Standard operating procedures

12.—(1) Purpose: To determine whether the laboratory has written standard operating procedures relating to all the important aspects of the laboratory’s operation, considering that one of the most important management techniques for controlling laboratory operations is the use of written standard operating procedures. These relate directly to the routine elements of tests conducted by the laboratory.

(2) The inspector should check that—

• each laboratory area has immediately available relevant, authorised copies of standard operating procedures,

• any amendments or changes to standard operating procedures have been authorised and dated,

• historical files of standard operating procedures are maintained,

• standard operating procedures are available for, but not necessarily limited to, the following activities—

  (i)

  receipt, identification, labelling, handling, sampling, usage and storage of test and reference substances,

  (ii)

  maintenance, cleaning and calibration of measuring apparatus and environmental control equipment,

  (iii)

  preparation of reagents and dosing formulations,

  (iv)

  record-keeping, reporting, storage and retrieval of records and reports,

  (v)

  preparation and environmental control of areas containing the test systems,

  (vi)

  receipt, transfer, location, characterisation, identification and care of test systems,

  (vii)

  handling of the test systems before, during and at the termination of the study,

  (viii)

  disposal of test systems,

  (ix)

  use of pest control and cleaning agents,

• quality assurance programme operations.