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Today Stability Tests are an integral part of Industry's Quality Assurance Programme. The stability predictions derived from the results of the Tests; represent a comprehensive assessment of quality, which applies to all batches and includes organoleptic, physicochemical, chemical and where applicable, microbiological criteriaThe aim is to describe, from Industry's point of view, what outlay is necessary for stability Testing for worldwide marketing and what degree of confidence lies behind the stability predictionsAlong the way from a new drug substance to routine production, 3 phases in Stability Testing can be distinguished- Preliminary and Stress experiments- Long term testing- Follow-up studiesEach phase has its own specific aim. The outlay and scope devoted to each phase must be appropriate to the particular problem. It is shown, which storage conditions are necessary, especially for the worldwide introduction of a drug product, the testing criteria, testing methods, number of batches and samples, duration of study and sequence. Finally the evaluation with the derivation of periods of stability is described
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W.M. Grimm (1986) studied this question.
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