Setting Specifications for Drug Substances and Drug Products

This 90-minute training will discuss the requirements of ICH for using testing and stability data to set specifications for drug substances and drug products including use of special stability studies. Attendees will also learn the requirements for changing specifications through the lifecycle of the product.

Why Should You Attend:

A specification is defined as a list of tests, references to analytical procedures and appropriate acceptance criteria that 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. ``Conformance to specifications'' means that the drug substance and drug product, when tested according to the listed analytical procedures and meeting the listed acceptance criteria.

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

Specifications are one part of a total control strategy for the drug substance and drug product designed to ensure product quality and consistency. Other parts of this strategy include thorough product characterization during development, upon which specifications are based and adherence to good manufacturing practices (GMP's), e.g., suitable facilities, a validated manufacturing process, validated test procedures, raw materials testing, in-process testing and stability testing.