ABSTRACT
The requirements in the document are of the Drug Evaluation Branch and apply only to the types of product for which the Branch has responsibility for registration. The validation data specified in the document are minimal and any additional necessary validation, as for example which would follow from the Code of Good Manufacturing Practice, must also be conducted. In accordance with the principles of Good Manufacturing Practice and with the goal of minimising batch to batch variation in stability and bioavailability, all batches should ideally be manufactured to a nominal formula with nil variations. “The re-processing of material which fails any intermediate or final specifications should be exceptional. A matrix indicating the time stations at which each of the tests will be conducted. Shelf lives may be extended in accordance with a stability test protocol which was approved explicitly for this purpose. An assurance that all aspects of pharmaceutical data are identical at all the sites.
