Guide to BioTerminology 2nd edition - - BioPharm International


Guide to BioTerminology 2nd edition

BioPharm International

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.

Controlled delivery covers a range of methods from surgical implantation (left) to sustained-release formulations.
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 21CFR 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 21CFR 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.

contaminant A foreign agent or material that is not introduced as part of processing, such as airborne particulates or adventitious organisms.

continuous process verification An alternative approach to process validation in which manufacturing process performance is continuously monitored and evaluated. [ICH Q8]

control group The group of subjects in a controlled study that receives no treatment, a standard treatment, or a placebo.

controlled delivery Drug delivery in which the duration (sustained delivery) and/or the site (targeted delivery) of drug release, action, and bioavailability are controlled through various physicochemical means designed to provide well-defined pharmacokinetic profiles.

convection Heat transfer that occurs due to mixing or motion of a fluid.

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