Division 10.1

The following should be retained in the archives for the period specified by the appropriate authorities:

1. (a)

   the study plan, raw data, samples of test and reference items, specimens, and the final report of each study;

2. (b)

   records of all inspections performed by the quality assurance programme, as well as master schedules;

3. (c)

   records of qualifications, training, experience and job descriptions of personnel;

4. (d)

   records and reports of the maintenance and calibration of apparatus;

5. (e)

   validation documentation for computerised systems;

6. (f)

   the historical file of all standard operating procedures;

7. (g)

   environmental monitoring records.

In the absence of a required retention period, the final disposition of any study materials should be documented. When samples of test and reference items and specimens are disposed of before the expiry of the required retention period for any reason, this should be justified and documented. Samples of test and reference items and specimens should be retained only as long as the quality of the preparation permits evaluation.