(2003; 148 pages)
17.23 Quality control should evaluate the quality and stability of finished pharmaceutical products and, when necessary, of starting materials and intermediate products.
17.24 Quality control should establish expiry dates and shelf-life specifications on the basis of stability tests related to storage conditions.
17.25 A written programme for ongoing stability determination should be developed and implemented to include elements such as:
(a) a complete description of the drug involved in the study;
(b) the complete set of testing parameters and methods, describing all tests for potency, purity, and physical characteristics and documented evidence that these tests indicate stability;
(c) provision for the inclusion of a sufficient number of batches;
(d) the testing schedule for each drug;
(e) provision for special storage conditions;
(f) provision for adequate sample retention;
(g) a summary of all the data generated, including the evaluation and the conclusions of the study.
17.26 Stability should be determined prior to marketing and following any significant changes in processes, equipment, packaging materials, etc.