ICH Q6
Specifications: Test Procedures and Acceptance Criteria
International framework for setting drug substance and drug product specifications — what to test for, at what stage, and what limits to apply.
ICH Q6A (chemical entities) and Q6B (biotechnological/biological products) define the structure of a specification: tests, analytical procedures and acceptance criteria. They cover universal tests (description, identification, assay, impurities) and dosage-form-specific tests (dissolution, content uniformity, microbial limits, sterility, endotoxins).
A properly justified specification per Q6 is what an OOS investigation falls back on. Specs too tight generate noise OOS; too loose and patient safety suffers — Q6's job is to keep that balance defensible.
- ICH Q6A
- ICH Q6B
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