The Good Laboratory Practice Regulations 1999

Standard operating procedures U.K.

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

(2) The inspector should check that—

• —each test facility area has immediately available relevant, authorised copies of standard operating procedures,

• —procedures exist for the revision and updating 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, determination of identity, purity, composition and stability, labelling, handling, sampling, usage, and storage of test and reference items,

  (ii)

  use, maintenance, cleaning, calibration and validation of measuring apparatus, computerised systems 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,

  (x)

  quality assurance programme operations.