Abstract
AbstractProcess validation for solid dosage forms must include a component that demonstrates content uniformity of the final blend. As a result of a recent court ruling this aspect of validation has received increased attention from both industry and government. In particular, the court ruled that the appropriate sample size for content uniformity testing of the final blend in validation batches is three times the run weight of the finished product. Furthermore, recent FDA communications suggest that the uniformity of the final blend should be held to a higher standard than that of the tablet in order to provide reasonable assurance that the finished product will exhibit acceptable uniformity. The purpose of this article is to communicate some problems that our firm encountered during the validation of a lower strength of a currently marketed tablet. The validated process for the marketed product has a long history of providing tablets that exhibit acceptable content uniformity at the higher strength. Ext...
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