GMP
Pharmaceutical quality guidelines
GMP stands for Good Manufacturing Practice, a system of regulations ensuring products are consistently produced and controlled according to quality standards.
GMP governs pharmaceutical, food, and cosmetic production: The FDA cited the facility for GMP violations.
In biochemistry, GMP also abbreviates guanosine monophosphate, a nucleotide involved in cellular signaling.
U.S. health regulator
- auditFormal accounts examination
- inspectionFormal assessment of condition
- documentationWritten proof or instructions
- validationConfirming truth or accuracy
protocols · accreditation · certification · ISO · licensure · verification · conformity · adherence
Manufactured therapeutic substances
- biotechnologyEngineering using living systems
- cleanroomParticle-free manufacturing space
- sterilityAbsence of microbes or fertility
- batchQuantity produced together
formulation · production · process · equipment · facility · contamination · scale-up · synthesis
FDA
U.S. health regulator
- auditFormal accounts examination
- inspectionFormal assessment of condition
- documentationWritten proof or instructions
validation · protocols · accreditation · certification · ISO · licensure · verification · conformity · adherence · enforcement
pharmaceuticals
Manufactured therapeutic substances
- biotechnologyEngineering using living systems
- cleanroomParticle-free manufacturing space
- sterilityAbsence of microbes or fertility
batch · formulation · production · process · equipment · facility · contamination · scale-up · synthesis · packaging
assurance
Firm promise or certainty
- controlAuthority to direct
- purityUncontaminated quality
- consistencyReliable adherence to standards
specifications · criteria · benchmark · standards · testing · sampling · release · stability · potency · identity
- food safetyfood safety, food hygiene, food handling, food poisoning, contamination
- Pharmaceuticscapsules, tablets, tableting, coatings, controlled release
- bioprocessingbioreactor, scale-up, batch processing, pilot plant, yeast fermentation
- bioregulationFDA approval, drug approval, biosafety, bioethics, human subjects
- Cleanroomsbunny suit, HEPA filter, laminar flow hood, anteroom, sticky mat
- FDAdrug approval, approval letter, drug recall, recalls, labeling laws
Failure to obey rules
adulteration · contamination · consent decree · debarment · self-regulation
Introduction of impurities
adulteration · unsafe conditions · cross-contamination · shoddy workmanship