You are here
Guidelines for sterility testing of therapeutic goods
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.