Regulatory Terms Starting With C

19 terms in the C index.

• CAPA (Corrective and Preventive Action)

  CAPA is the quality-system element that investigates a detected problem to root cause and eliminates that cause so it cannot recur, unlike a correction, which only fixes the affected batch.

• CBER (Center for Biologics Evaluation and Research)

  CBER is the FDA center that licenses biological products under section 351 of the Public Health Service Act, covering vaccines, blood, allergenics, human tissues, and cell and gene therapies, rather than the therapeutic proteins CDER reviews.

• CDER (Center for Drug Evaluation and Research)

  CDER is the FDA center that reviews human drugs, covering prescription, over-the-counter, and generic products plus most therapeutic biologics, while vaccines, blood products, and cell and gene therapies are reviewed by CBER.

• CDRH (Center for Devices and Radiological Health)

  CDRH is the FDA center that regulates medical devices, in vitro diagnostics, and radiation-emitting electronic products, reviewing premarket submissions such as the 510(k) and enforcing quality-system and adverse-event reporting duties after market entry.

• cGMP (Current Good Manufacturing Practice)

  Current Good Manufacturing Practice (cGMP) is the FDA-enforced minimum standard for the methods, facilities, and controls used to manufacture, process, pack, and hold drugs. Drugs made outside cGMP are adulterated by law, regardless of how the batch tests.

• Class I (Class I Medical Device)

  Class I is FDA's lowest-risk medical device class, covering devices for which general controls alone provide reasonable assurance of safety and effectiveness, without the special controls or premarket approval higher classes require.

• Class II Medical Device (Class II)

  Class II medical devices are the FDA device class subject to special controls, the additional device-type-specific requirements necessary to reasonably assure safety and effectiveness for a generic device type, beyond the general controls every device must meet.

• Class III Medical Device (Class III)

  Class III medical devices are the FDA's highest-risk device class, covering devices that are life-supporting, life-sustaining, or present a potential unreasonable risk of illness or injury, and require premarket approval rather than 510(k) clearance.

• Clinical Hold (Clinical Hold)

  A clinical hold is an FDA order under an IND that delays a proposed clinical investigation or suspends an ongoing one, halting dosing until the sponsor corrects the deficiencies FDA cited in writing.

• Clinical Trial Application (CTA)

  Clinical Trial Application (CTA) is the authorisation dossier a sponsor files with a national or EU regulator before dosing the first subject in a trial of an investigational medicinal product, the non-US counterpart to an FDA IND.

• CMC (Chemistry, Manufacturing, and Controls)

  CMC is the quality section of a drug application, covering the composition, manufacturing process, and controls for drug substance and drug product, as opposed to the nonclinical and clinical sections that establish safety and efficacy.

• Combination Product (Combination Product)

  A combination product is a medical product composed of two or more regulated constituent parts - drug, device, or biological - that FDA regulates through one lead center, assigned by the constituent part providing the product's primary mode of action.

• Compendial Method (Compendial Method)

  Compendial Method is an analytical procedure published in an official pharmacopoeia such as USP-NF that a manufacturer may cite by reference instead of documenting its own accuracy and reliability data. Suitability still must be verified in the using laboratory.

• Complete Response Letter (CRL)

  Complete Response Letter is the FDA action letter that closes a review cycle without approval, describing every deficiency the agency identified that a sponsor must resolve before an NDA, ANDA, or BLA can be approved.

• Contract Research Organization (CRO)

  A Contract Research Organization is an independent contractor that assumes, under written transfer from a sponsor, one or more of that sponsor's regulatory obligations for a clinical investigation and must itself comply with the regulations governing them.

• Control Strategy (Control Strategy)

  A control strategy is the complete planned set of controls, spanning input materials, process parameters, in-process tests, and release specifications, that together assure process performance and product quality. No single specification is the control strategy.

• Critical Process Parameter (CPP)

  Critical Process Parameter is a manufacturing process input whose variability measurably impacts a critical quality attribute, and which therefore must be monitored or controlled within a justified range so the process delivers the intended quality.

• Critical Quality Attribute (CQA)

  A Critical Quality Attribute is a physical, chemical, biological, or microbiological property of a drug substance, excipient, intermediate, or drug product that must be held within a defined limit, range, or distribution because its variation would compromise product quality.

• CTD (Common Technical Document)

  Common Technical Document is the ICH-harmonized dossier structure that fixes what content belongs in each of five modules of a drug application, letting one technical package serve regulators across the ICH regions.