Specification: A document giving a description of a starting material, packing material, intermediate bulk or finished product in terms of its chemical, physical and biological characteristics.

The International Conference on Harmonization (ICH) defines specifications 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.”

Specification may be a important quality customary that establishes the set of criteria to that a drug substance or drug product ought to change to be thought of acceptable for its meant use. The specifications square measure projected and even by the manufacturer and approved by regulative authorities as conditions of approval.

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