The Good Laboratory Practice Regulations 1999 No. 3106

SCHEDULE 2 U.K. REVISED GUIDANCE FOR THE CONDUCTOF TEST FACILITY INSPECTIONS AND STUDY AUDITS [F1 (BASED ON PART OF PART B OF ANNEX I TO THE EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE 2004/9/EC)]

Textual Amendments

F1 Words in Sch. 2 heading substituted (27.4.2004) by The Good Laboratory Practice (Codification Amendments Etc.) Regulations 2004 (S.I. 2004/994), regs. 1, 2(e)

PART II U.K. STUDY AUDITS

1.  Test facility inspections will generally include, inter alia, study audits, which review on-going or completed regulatory studies. Specific study audits are also often requested by regulatory authorities, and can be conducted independently of test facility inspections. Because of the wide variation in the types of regulatory studies which might be audited, only general guidance is appropriate, and inspectors and others taking part in study audits will always need to exercise judgement as to the nature and extent of their examinations. The objective should be to reconstruct the study by comparing the final report with the study plan, relevant standard operating procedures, raw data and other archived material. U.K.

2.  In some cases, inspectors may need assistance from other experts in order to conduct an effective study audit, for example where there is a need to examine tissue sections under the microscope. U.K.

3.  When conducting a study audit, the inspector should— U.K.

• —obtain names, job descriptions and summaries of training and experience for selected personnel engaged in the study(ies) such as the study director and principal scientists,

• —check that there is sufficient staff trained in relevant areas for the study(ies) undertaken,

• —identify individual items of apparatus or special equipment used in the study and examine the calibration, maintenance and service records for the equipment,

• —review the records relating to the stability of the test items, analyses of test items and formulations, analyses of feed, etc.,

• —attempt to determine, through the interview process if possible, the work assignments of selected individuals participating in the study to ascertain if these individuals had the time to accomplish the tasks specified in the study plan or report,

• —obtain copies of all documentation concerning control procedures or forming integral parts of the study, including—

  (i)

  the study plan,

  (ii)

  standard operating procedures in use at the time the study was done,

  (iii)

  log books, laboratory notebooks, files, worksheets, print-outs of computer-stored data, etc., checking calculations where appropriate,

  (iv)

  the final report.

4.  In studies in which animals (i.e. rodents and other mammals) are used, the inspector should follow a certain percentage of individual animals from their arrival at the test facility to autopsy. They should pay particular attention to the records relating to: U.K.

• —animal body weight, food/water intake, dose formulation and administration etc.,

• —clinical observations and autopsy findings,

• —clinical chemistry,

• —pathology.