Glossary
Specification
The set of tests, analytical procedures, and acceptance criteria against which a material is judged suitable for its intended use.
Source · WHO Quality Assurance of Medicines Terminology Database, Specifications
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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For example, your firm has not established scientifically sound and appropriate specifications and test procedures to assure your product conforms to appropriate standards of identity, strength, quality, and purity.
FDA · FDA Warning Letter · 2026-09-22 -
Your firm did not have adequate stability data to demonstrate that the chemical and microbiological properties of your drug products met established specifications and remain acceptable throughout their…
FDA · FDA Warning Letter · 2024-08-13 -
You have not established scientifically sound and appropriate specifications and test procedures to assure that VBM, CFM/EFM, and OVM conform to appropriate standards of identity, strength, quality, and…
FDA · FDA Warning Letter · 2024-08-27
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
WHO Quality Assurance of Medicines Terminology Database, SpecificationsGRM Regulatory Glossary
243 GMP terms in one place
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