Paragraph 18

When conducting a study audit, the inspector should—

• 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 are 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 substances, analyses of test substance 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—

  1. (i)

     the study plan,

  2. (ii)

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

  3. (iii)

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

  4. (iv)

     the final report.