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CMC Chemistry, manufacturing, and controb; the section of a BLA, NDA, or IND describing the composition, manufacture, and specifications of a drug product and its ingredients.

CMO Contract manufacturing organization; a company contracted to perform development and/or manufacturing services.

codon A sequence of three nucleotide bases that specifies production of an amino acid or represents a signal to stop or start a function.

colorimetry The measurement and definition of unknown colors in terms of standard colors; techniques may be visual, photoelectric, or spectrophotometric; colorimetry is useful in determining the concentration of a chemical with color in a solution by measuring the intensity of the color and relating that intensity to the concentration of the solution.

column A vertical, cylindrical container or vessel often used in separation processes such as extraction, distillation, and chromatography.

Colorimetry is the science of measuring colors, often used to determine the concentration of a chemical in a solution.
column aspect ratio The ratio of a column's height to its diameter.

column chromatography A separation method in which the different components of a mixture migrate through a column at different rates of speed based on their relative affinity for the stationary phase.

comparable Product made before and after a given process change is comparable if the change is shown to have no adverse effect on the key quality attributes of the product, such as purity, potency, PK/PD, stability, and safety. Small differences in, for example, the impurity profile are permitted, as long as the function is not affected. (See equivalent)

comparability protocol A protocol that defines the experiments and acceptance criteria that will be used to evaluate a product before and after a process change, and if met, will provide documented evidence that the products are comparable. A comparability protocol may be filed within another regulatory submission, such as a BLA; or may be filed on its own. One reason to file a comparability protocol is that FDA may grant a less stringent category to the change, so that what required a PAS now requires only a CBE-30.

complaint Also customer complaint; any oral or written communication from an end user of a medicinal product indicating that it had an adverse effect on a patient, did not function as specified, or appeared to be contaminated or defective in any way. The sponsor must promptly investigate all such complaints and document the investigation in a retrievable file. If the complaint is confirmed, corrective and preventive actions are required. Examples include FDA notification, product lot(s) withdrawal, product recall, and review of medical files of adverse events caused by the product. These requirements are found in US regulations in 21 CFR 314, the GCP regulations.

complement A group of proteins in the blood that work in concert with other immune system proteins and cells (such as antibodies) in attacking foreign substances.

component 1. Raw materials and components (tubing, stoppers, vials, filters) having direct product contact during manufacturing, which are regulated under 21 CFR 84. 2. Differentiated from raw materials and excipients, which are chemical entities, and usually rated as lower in risk to patient and product quality. (Note: These terms may be used interchangeably or loosely, and definitions vary between US, Europe, and WHO). (See raw material, starting material, API)

concentration The amount of a particular substance in a given quantity of solution, usually stated as a percentage by weight or volume, as weight per unit volume, as molarity (a one-molar solution contains one gram-mole of solute per liter of solution), or as normality (a one-normal or one-molar solution contains one gram-equivalent weight of solute per liter of solution).

conformation The shape of a molecule, produced by the specific spatial arrangement of the units that compose it.

consent decree Status imposed by FDA on a company in serious violation of federal regulations and related safety and quality standards. A company must agree to a series of measures aimed at bringing its manufacturing standards into compliance with federal regulations. Until agreed-upon conditions are met, a company may be forbidden to distribute its products in interstate commerce, except for those products deemed essential for the public health.

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