Guidance for Industry: Drug Product Chemistry, Manufacturing, and Controls Information
Guidance for Industry: Drug Product Chemistry, Manufacturing, and Controls Information
This guidance document is being distributed for comment purposes only.
Comments and suggestions regarding this draft document should be submitted within 150 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the `Federal Register.
For questions regarding this draft document contact (CDER) Upinder Atwal 301-827-5848 or (CBER) Christopher Joneckis 301-435-5681.
This guidance provides recommendations on the chemistry, manufacturing, and controls (CMC) information for drug products that should be submitted in original new drug applications (NDAs) and abbreviated new drug applications (ANDAs). The guidance addresses the content of original NDAs and ANDAs. The guidance is structured to facilitate the preparation of applications submitted in Common Technical Document (CTD) format (see section II.A and B). The recommendations apply to all NDAs and ANDAs, although more detailed guidance on the content of an application may be available in separate guidance documents for specific types of drug products or dosage forms (see section II.C).
This guidance addresses the information to be submitted for marketing approval of drug products to ensure continued product quality (i.e., the identity, strength, quality, purity, and potency). Recommendations are provided on the information that should be included for (1) description and composition of the drug product, (2) manufacture, (3) control of excipients, (4) control of drug products, (5) reference standards or materials, (6) container closure systems, and (7) 2 This guidance has been prepared by the Drug Product Technical Committee of the Chemistry, Manufacturing, and Controls Coordinating Committee (CMC CC) in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration in collaboration with the Center for Biologics Evaluations and Research (CBER).
This guidance, when finalized, will replace the guidance entitled Submitting Documentation for the Manufacture of and Controls for Drug Products (February 1987).
Complete guidelines can be viewed online.
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