Chemistry, manufacturing, and controls CMC information

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. ... 

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. 

GUIDANCE FOR INDUSTRY1—IND MEETINGS FOR HUMAN DRUGS AND BIOLOGICS. CHEMISTRY, MANUFACTURING, AND CONTROLS (CMC) INFORMATION... 

Complete Chemistry, Manufacturing, and Control (CMC) information provided, including evidence of purity, stability, toxicology testing, and integrity of active pharmaceutical ingredient (API), placebo, and final product. 

Guidance for FDA Review Staff and Sponsors Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) (draft guidance) (November 2004) Current Good Tissue Practices for Human Cell, Tissue, and Cellular Tissue-Based Product Establishments Inspection and Enforcement (November 2004)... 

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). 

Chemistry, manufacturing, and control (CMC), where some physicochemical information of the drug (referred to as preformulation studies) is required... 

For the Submission of Chemistry, Manufacturing, and Controls Information for a Theraputic Recombinant DNA-Derived Product or a Monoclonal Antibody for In Vivo Use (CMC) August 1996... 

Part 7 Chemistry, Manufacturing, and Control Data. This section is also easier to review and better formatted with the use of subparts. Any number of approaches are acceptable however, one logical formatting technique is to provide the CMC data for the drug substance as subpart (a), data for the drug product as subpart (b), information relating to any placebo formulations as subpart (c), labeling as subpart (d), and finally all environmental assessment information as subpart (e). 

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