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GUIDANCE DOCUMENT

CVM GFI #169 Drug Substance Chemistry, Manufacturing, and Controls Information August 2010

Final
Docket Number:
FDA-2003-D-0243
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

Information on the chemistry, manufacturing, and controls (CMC) for the drug substance must be submitted to support the approval of original new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs). This guidance provides recommendations on the CMC information for drug substances that should be submitted to support these applications. The guidance is structured to facilitate the preparation of applications submitted in Common Technical Document (CTD) format.

This guidance addresses the information to be submitted for drug substances to ensure continued drug substance and drug product quality (i.e., the identity, strength, quality, purity, and potency). This guidance provides recommendations on the information that should be included for the following topics:

  • Nomenclature, structure, and general drug substance properties
  • Manufacture
  • Characterization
  • Control of drug substance
  • Reference standards or materials
  • Container closure system
  • Stability

The recommendations provided in this guidance apply to the following types of drug substances:

  • Drug substances manufactured by chemical synthesis
  • Highly purified and well-characterized drug substances derived from plants or animals
  • Semisynthetic drug substances manufactured by the chemical modification of a highly purified and well-characterized intermediate derived from plants or animals
  • The synthetic portion of the manufacturing process for semisynthetic drug substances manufactured by the chemical modification of an intermediate produced by conventional fermentation.

The guidance does not provide specific recommendations relating to the following:

  • Monoclonal antibodies
  • Peptides
  • Oligonucleotides
  • Radiopharmaceuticals
  • Medical gases
  • Drug substances that are not well characterized (e.g., botanicals, some proteins) derived from plants or animals
  • Drug substances derived using transgenic technology
  • Drug substances derived directly from or manufacturing operations involving fermentation (conventional fermentation or using rDNA technology) or tissue or cell culture.

Submit Comments

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:

Dockets Management
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-2003-D-0243.

Questions?

Contact Point
CVM
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Pl, HFV-1
Rockville, MD 20855
AskCVM@fda.hhs.gov
(240) 402-7002