ICH Q6 — Specifications

Q6A and Q6B: how acceptance criteria and the associated tests are chosen for small-molecule and biological products — the document that turns science into a pass/fail line.

Outline and talking points — the full write-up is still to come.

What this page covers

  • What a specification is: a list of tests, references to analytical procedures, and acceptance criteria — the contract for release.
  • Q6A — small molecules: universal tests (description, identification, assay, impurities) plus dosage-form-specific tests (dissolution, uniformity, water, etc.); decision trees.
  • Q6B — biotech / biologics: identity, purity and impurities (product-related vs. process-related), potency, quantity — and why heterogeneity is expected, not a defect.
  • The idea of acceptance criteria as a hypothesis: set from clinical/stability experience, revised as knowledge grows (links to Q1 and Q8–Q12 lifecycle).

Lecture prep — open items

  • Side-by-side: a small-molecule tablet spec vs. a monoclonal antibody spec.
  • Walk one Q6A decision tree (e.g. when is a dissolution test required, and what kind).
  • How specification limits get tightened or widened post-approval, and the regulatory mechanism for it.