31 terms that appear in manufacturing planning, review, and readiness workflows.
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.
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.
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.
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.
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.
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.
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.
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 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.