52 terms that appear in quality planning, review, and readiness workflows.
Abbreviated 510(k) is a premarket notification format in which conformance to an FDA-recognized consensus standard, special control, or guidance document substitutes for the device-by-device test summaries a Traditional 510(k) requires.
Active Pharmaceutical Ingredient (API), also called the drug substance, is the component of a drug product intended to furnish pharmacological activity or other direct effect on the body. Every other component of the dosage form is an inactive ingredient.
Annex 1 is the European Union GMP guideline governing the manufacture of sterile medicinal products, distinguished from other GMP annexes by mandating a facility-wide Contamination Control Strategy and graded cleanroom control, in force since 25 August 2023.
Audit trail is the secure, computer-generated, time-stamped metadata record of who created, modified, or deleted a regulated record and when, captured independently of the record so that previously recorded values are never obscured.
A batch record is the controlled document that both instructs and evidences the manufacture of a single batch of drug product, capturing actual materials, equipment, parameters, yields, deviations, and operator signatures step by step.
Biocompatibility is the property of a finished medical device to contact tissue, blood, or bone without provoking an unacceptable adverse biological response, evaluated for a defined contact category and duration rather than material by material.
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.
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 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 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 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.
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.
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 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.
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 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.
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.
De Novo Classification Request is an FDA premarket submission that asks the agency to classify a novel device into class I or class II when no legally marketed device exists to support a 510(k) substantial equivalence review.
Design controls are the FDA-mandated design and development requirements for medical devices, governing how a device is planned, specified, verified, validated, and transferred to production, unlike production controls that govern manufacture of an already-approved design.
Design Space is the regulator-approved multivariate region of input material attributes and process parameters demonstrated to assure quality, inside which a manufacturer can move without filing a post-approval change.
Deviation is a departure from an approved instruction, procedure, specification, or established standard in a regulated process, which GMP requires to be recorded and justified, and investigated whenever it is critical or unexplained.
Elemental impurities are inorganic contaminants, principally metals such as arsenic, cadmium, mercury and lead, that reach a drug product from catalysts, drug substances, excipients, water, manufacturing equipment or container closure systems rather than being added for therapeutic benefit.
Endotoxin testing is the quality control assay that quantifies bacterial lipopolysaccharide in parenteral drugs, biologics, and blood-contacting devices, detecting one specific fever-causing contaminant rather than all pyrogens or viable microorganisms.
eSTAR is FDA's interactive PDF submission template, mandatory for 510(k) and De Novo submissions, that the CDRH Portal rejects until every applicable field and attachment is complete. eSTAR use stays voluntary for PMA, IDE, 513(g), and Q-Submissions.
EU GMP Annex 11 is the EudraLex Volume 4 annex governing computerised systems used in GMP-regulated activities, covering lifecycle risk management, validation, audit trails, access control and periodic evaluation, not only the electronic records and signatures Part 11 addresses.
An excipient is any component of a drug product other than the active ingredient: the binders, diluents, buffers, coatings and preservatives that carry, stabilize or deliver the drug without pharmacological activity of their own.
GMP is the minimum standard for the methods, facilities, and controls used to manufacture a drug, enforced through adulteration: a drug made outside GMP is legally adulterated regardless of whether it passes its release tests.
Good Laboratory Practice is the FDA quality system at 21 CFR Part 58 governing nonclinical safety studies submitted for research or marketing permits, distinguishing pivotal toxicology work from exploratory laboratory research that carries no such obligations.
ICH M7 is the harmonised guideline governing assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals, setting acceptable intake limits that ICH Q3A and Q3B leave undefined for genotoxic impurities.
IEC 62304 is the international standard defining the life cycle processes for medical device software, covering development and maintenance of software that is itself a device or embedded in one, but stopping short of final device validation and release.
Investigational Device Exemption is FDA authorization to ship and use an uncleared or unapproved device in a clinical investigation, exempting it from premarket approval and performance-standard requirements while safety and effectiveness data is collected.
ISO 14971 is the international consensus standard for applying risk management to medical devices, covering the identification, evaluation, and control of risk to patients and users across the product lifecycle rather than at a single design stage.
IVDs are reagents, instruments, and systems intended for use in diagnosing disease or other conditions, including determining a state of health. They are regulated as medical devices but act on specimens taken from the body, not the patient.
PMA is the FDA's most stringent device marketing application, the pathway by which a Class III device wins approval on its own clinical and nonclinical evidence rather than by demonstrating equivalence to a marketed predicate.
Process Analytical Technology is a system for designing, analyzing and controlling pharmaceutical manufacturing through measurements taken during processing rather than after it, so quality is assured by in-process control instead of end-product testing alone.
Process Validation is the documented, data-based demonstration that a manufacturing process consistently produces drug product meeting predetermined specifications, spanning process design through routine commercial production rather than a one-time qualification exercise.
Process validation is the documented, lifecycle-long demonstration that a commercial manufacturing process reliably yields conforming product, distinguished from equipment qualification by proving the process itself, not the machinery, performs within defined limits.
Q-Submission is FDA's umbrella mechanism for a device sponsor to request feedback or a meeting rather than a marketing decision, covering Pre-Submissions, Submission Issue Requests, Study Risk Determinations, and Informational Meetings.
A Quality Agreement is a written cGMP contract between a drug owner and a contract facility that assigns each quality responsibility (batch release, deviation investigation, change control, audit rights) to one named party, separate from the commercial supply agreement.
Quality by Design is a systematic pharmaceutical development approach that fixes quality targets before experimentation, then builds product and process understanding until quality is designed into the manufacturing process rather than tested into the finished batch.
Quality System is the documented management framework a regulated manufacturer uses to direct product quality across the lifecycle, distinct from GMP's minimum production rules by adding management responsibility, monitoring, and continual improvement obligations.
Quality System Regulation (QSR) was FDA's device current good manufacturing practice framework at 21 CFR Part 820, governing design and manufacture of finished devices until the Quality Management System Regulation superseded it on February 2, 2026.
Quality Target Product Profile is a prospective summary of the quality characteristics a drug product must achieve, covering dosage form, strength, delivery, release and stability, from which every critical quality attribute in the control strategy is derived.
Stability testing is the formal study program that measures how a drug substance or product changes under defined temperature, humidity, and light conditions, generating the evidence that sets shelf life, storage conditions, and the expiration date on the label.
Supplier qualification is the documented assessment that establishes a supplier's ability to consistently provide materials or services meeting specification, and the ongoing verification that keeps that conclusion current.