Article | December 21, 2020

How To Understand ASTM E2500

Source: CAI

By Robert Chew, PE

biologics syringe 3 450x300

ASTM E2500 introduced the term “verification” but was essentially silent on the idea of “commissioning” and the term “qualification.” The team who wrote the standard had avoided “qualification” because it is not found in the US GMPs and therefore is not a regulatory requirement, at least in the US. For other regions such as the European Union where IQ/ OQ/PQ* is explicitly mentioned, there was nothing in the standard prohibiting labeling documents as such instead of “verification”. But industry got wrapped around such terminology, and teams that created IQ/OQ/PQ protocols were said to be using a “hybrid” ASTM approach. Not so – ASTM is a minimum standard, and teams are free to go beyond this minimum as long as the basic provisions are met: basing what is critical (critical aspects) on process science, quality risk control; using subject matter experts and involvement of QA as specified in the standard, etc.

We see four basic approaches in the industry currently.

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