-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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