Specification in Pharmaceutical Industry

-Specification is a document describing the list of the test and appropriate acceptance criteria which may be description or range. Specifications serve as bases for quality evaluation.

-As per ICH guideline
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 set of criteria to which a drug substance or drug product should conform to be considered acceptable for its intended use.

-Specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities as conditions of approval.

-Specifications for finished products shall include:
      
-The designated name of the product and the code reference where applicable.
-The designated name of the active ingredient.( if applicable, the International Non – proprietary name )
-Reference of the Pharmacopeia
-A description of the dosage
-The qualitative and quantitative requirements with acceptance limits
(Identity, purity, physical & chemical characteristics, microbiological standards, assay etc as per the requirement)
-The storage conditions and precautions where applicable.
-The shelf life of the product
-Packaging details



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