CRED Getting the CMC Dossier Right 2024

28/08/2024

Specifications - ICH Q6A and Q6B

● A specification is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria which are numerical limits, ranges, or other criteria for the tests described.

● It establishes the set of criteria to which a drug substance......should conform to be considered acceptable for its intended use.

● “Conformance to specification” means that the drug substance ....., when tested according to the listed analytical procedures, will meet the listed acceptance criteria.

● Specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities as conditions of approval.

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Establishing a Specification

Is there a universal set of tests for drug substances?

Some specification tests are required for all substances

● Many additional tests are drug product specific based on developed understanding of CQAs https://upload.wikimedia.org/wikipedia/commons/thumb/d/d5/Archery_Target_80cm.svg/220px-Archery_Target_80cm.svg.png

ICH Guidelines for specifications

● See detailed slide in back ups

Key data to consider

● Prior knowledge / Development data ● Representative manufacturing data ● Drug substance control strategy

Specification very likely to change as development progresses

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