Definition

List of tests, references to analytical procedures, and acceptance criteria (limits, ranges) that a drug substance or drug product must meet to be released.

Example

Assay 98.0–102.0%, dissolution Q 80% in 30 min, microbial limits per PhEur.

Regulatory source

ICH Q6A, ICH Q6B

Common mistakes

Setting specifications without linking to clinical batches or stability data. Tightening specs post-approval without a variation.

Inspector question

How were the release and shelf-life specifications justified? Show me the specification history.

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