ABSTRACT
The International Conference on Harmonization and Committee for Proprietary Medicinal Products guideline mentions the possibility of reducing the scheduled test points where the stability of the samples tested represents the stability of all types of substance and products being assessed. It also recommends that the applicant should consult the licensing authorities when planning to apply such concepts in setting up the stability protocol and specifically mentions bracketing or matrixing. The concept of using a reduced testing plan is acceptable only for substances or products which are closely related. The design of a stability schedule so that at any time point only the samples on the extremes, for example, of container size and/or dosage strengths, are tested. The design assumes that the stability of the intermediate condition samples is represented by the extremes. The statistical design of a stability schedule so that only a fraction of the total number of samples are tested at any specified sampling point.
