ABSTRACT
The specifications for a finished pharmaceutical product are an approved list of tests and associated an acceptance criterion that is expected of a product at batch release and throughout its shelf life. The International Council for Harmonisation Q6A provides a suitable working definition of specifications for a new drug substances or product that can also be applied to marketed products. The product specification in early stages of clinical investigation is designed to ensure the safety of the product in the clinical setting and to provide reasonable assurance of the integrity of conclusions derived from the study. A specification contains requirements that are expected of the product at batch release and throughout its shelf life. For those test results that change during the product’s shelf life, test results at the time of product release must meet limits narrower than the product acceptance criteria to ensure that the batch remains within the acceptance criteria throughout its shelf life.
