SPECIFICATIONS FOR NEW DRUG SUBSTANCES AND NEW DRUG PRODUCTS ( QUALITY CONTROL)
SPECIFICATIONS: Test Procedures And Acceptance Criteria For New Drug Substances And New Drug Products: Chemical Substance. Specifications: Definition and Justification Definition of Specifications:- A specification is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria which are numerical limits, ranges, or other criteria for the tests described. It establishes the …
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