Specification
Pharmaceutical Raw Material Specification and Template
A raw material 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. When a specification is first proposed, justification should be presented for each procedure and each acceptance criterion included. The ... Read More
Pharmaceutical Finished Product Specification and Template
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. When a specification is first proposed, justification should be presented for each procedure and each acceptance criterion included. ... Read More