Acceptance criteria potency

Biological assays, in particular potency assays, are meant to demonstrate a relationship between the product and the desired biological effect. The correlation between the activity measured by the potency assay and the resulting clinical effect is an important criterion in both dosing and the determination of efficacy. International or other accepted reference standards, when available, should be incorporated in the assay. 

When applying fillers it is also difficult to associate different degrees of importance to failures of different criteria. For example, it may be altical to meet the criterion for one property, for example, potency against the therapeutic target, while it may be appropriate to compromise on other properties in order to achieve good outcomes for critical factors. It is rare to find a perfect componnd and, therefore, it is important to explore acceptable trade-offs. 

The particular requirements for processing (e.g., batch size, fill volume, container) are agreed between the Standards Division and the responsible scientists for individual fills, prior to processing requests being accepted. The fundamental criterion is that data submitted to the ECBS demonstrate fitness for intended use. In addition, every eontainer (ampoule or vial) should be identical, in terms of quantity, potency, composition, and stability. 

---