ICH Q6A defines a specification as a list of tests, references to analytical procedures and appropriate acceptance criteria — numerical limits, ranges or other criteria — that a drug substance or drug product must conform to in order to be considered acceptable for its intended use. Specifications exist for starting materials, packaging components, intermediates, finished products and stability testing.
A specification is a controlled document. It is prepared, reviewed and approved, carries a version number, and changes only through change control. Where a product is registered, the specification must match the marketing authorisation, and a change may need regulatory approval.
Why it matters in GMP
Every QC verdict depends on the specification used. If a laboratory tests against an outdated version, or if limits are edited while samples are open, a result can pass that should have failed. Inspectors check that results are evaluated against the approved version that was in force, and that changes to limits are traceable.
- Approve each version through independent review.
- Freeze the version used for each sample, so later changes never rewrite past verdicts.
- Distinguish major from minor changes in the version history.
How Swat iQua Suite handles it
In Swat iQua Suite, specification approval freezes a version snapshot that cannot be changed: a major change creates a new version and a minor change a new revision. Review and approval are e-signed by people other than the preparer, with no admin bypass. Specifications hold methods and child methods, alert and action limits and an identity-test flag, and can be shared read-only across sites. The version is frozen when a sample is registered, and the specification is locked while samples are open.