Chemistry, manufacturing and controls

The policy gives further recommendations on the information which should be provided on chemistry, manufacturing and controls (CMC) in addition to that found in other guidance (see Section 13.3.6). 

LABELING SUPPLEMENT f1 CHEMISTRY MANUFACTURING AND CONTROLS SUPPlEMgwr OTHER... 

Chemistry, Manufacturing, and Controls Supplement = manufacturing change supplement submissions as provided in 21 CFR314.70,21 CFR314.71,21 CFR314.72 and21 CFR 601.12 ... 

Draft Guidance for Industry-Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products Chemistry, Manufacturing, and Controls Documentation, Nov. 13, 1998. 

Drug Studies in Pediatric Patients Medical Officer s Review Statistical Review Evaluation Chemistry, Manufacturing and Controls CDER Labeling and Nomenclature Committee Clinical Pharmacology/Biopharmaceutics Microbiologist s Review Pharmacokinetics Review Carcinogenicity Assessment... 

CDER Guidance for Industry. SUPAC-IR Immediate-Release Solid Oral Dosage Forms Scale-Up and Post-Approval Changes Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation US Food and Drug Administration, 1995. 

Chemistry, Manufacturing, and Controis As stated in 21 CFR Part 312, chemistry, manufacturing, and controls (CMC) information is to describe the composition, manufacture, and controls of the drug substance and the drug product... sufficient information is required to be submitted to assure the proper identification, quality, purity and strength of the investigational drug. ... 

Food and Drug Administration. Guidance for Industry, Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product, FDA, Rockville, MD, 1999. 

Regulatory authorities such as the FDA have prepared guidelines on comparability protocol, Comparability Protocols—Chemistry, Manufacturing and Controls Information, to enable manufacturers to follow a plan to establish and substantiate that changes to postapproval processes do not affect drug quality. 

In some cases, drug materials are isolated from natural products. In other cases, natural product extraction constitutes the raw material or intermediate for production of the drug via a semisynthetic route. Methods for chemical reactions, product purification, control parameters, and analytical procedures are developed and they form the basis for the chemistry, manufacturing, and control (CMC) information for regulatory application. 

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