You are here

Guidelines for sterility testing of therapeutic goods

13 September 2006

Book pagination

5. Records

500. Reference: PIC/S Recommendations on Sterility Testing (PS/W 2/98).

501. Records should be kept of all sterility testing which is carried out.

502. For each test these records should contain at least the following information:

  • description and number of product units tested;
  • batch/lot number;
  • stage of manufacture (finished product, intermediate or final bulk);
  • personnel performing tests;
  • dates of testing;
  • test  methodology  (volume  tested,  diluents/solvents  used,  media,  media  batch numbers, temperature and time of incubation);
  • results in full.

503. Records should also be maintained of:

  • details of validation of the sterility test method;
  • periodic stasis testing;
  • details of any product contamination irrespective of whether the test was valid or invalid;
  • the negative control contamination rate;
  • results of environmental and personnel monitoring.

504. Results of sterility testing for test samples and negative controls should be presented in a format that allows for easy recognition of trends.

505. These  records  should  be  appropriately  stored  and  readily  available  as  defined  in Chapter 4 of the Australian Code of Good Manufacturing Practice for Medicinal Products, 2002.

Book pagination