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Guidance Issuing OfficeCenter for Veterinary Medicine
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, medicinal product, or materials at other stages of its manufacture should conform to be considered acceptable for its intended use. “Conformance to specification” means that the drug substance and medicinal product, when tested according to the listed analytical procedures, will meet the 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 designed to ensure product quality and consistency. Other parts of this strategy include thorough product characterization during development, upon which many of the specifications are based, adherence to Good Manufacturing Practices (GMPs), a validated manufacturing process, raw materials testing, in-process testing, stability testing, etc.
Specifications are chosen to confirm the quality of the drug substance and medicinal product rather than to establish full characterization and should focus on those molecular and biological characteristics found to be useful in ensuring the safety and efficacy of the product.
The principles adopted and explained in this document apply to products composed of well-characterized proteins and polypeptides, and their derivatives which are isolated from tissues, body fluids, cell cultures, or produced using recombinant deoxyribonucleic acid (r-DNA) technology. Thus, the document covers the generation and submission of specifications for products such as cytokines, growth hormones and growth factors, insulins, and monoclonal antibodies. This document does not cover antibiotics, heparins, vitamins, cell metabolites, DNA products, allergenic extracts, vaccines, cells, whole blood, and cellular blood components.
A separate VICH Guidance (GL39), "Specifications: Test Procedures and Acceptance for New Veterinary Drug Substances and Medicinal Products: Chemical Substances" addresses specifications, and other criteria for chemical substances.
This document does not recommend specific test procedures or specific acceptance criteria nor does it apply to the regulation of preclinical and/or clinical research material.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2005-D-0028.