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The suitability of either a drug substance or drug product for its intended use. This term includes such attributes as the identity, strength, and purity (from ICH Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances).
Publication Source: GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems
Publication Date: 2008
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