Quality Terms (40)
40 terms that appear in quality planning, review, and readiness workflows.
Accelerated Stability
Accelerated Stability is used to prevent quality failures and strengthen manufacturing control strategy.
Active Pharmaceutical Ingredient(API)
The substance in a pharmaceutical drug that is biologically active and produces the intended therapeutic effect.
Adaptive TRIAL DESIGN
Adaptive TRIAL DESIGN is an important device-regulatory concept for pathway selection, evidence strategy, and compliance.
Analytical METHOD Validation
Analytical METHOD Validation is foundational for process control, product quality, and inspection-readiness in manufacturing.
AUDIT TRAIL
AUDIT TRAIL is used to support defensible premarket and postmarket device decisions.
Center for Devices and Radiological Health(CDRH)
CDRH is the FDA center that regulates medical devices and radiation-emitting electronic products in the United States.
CGMP(CGMP)
CGMP is foundational for process control, product quality, and inspection-readiness in manufacturing.
Chemistry, Manufacturing, and Controls(CMC)
The section of a regulatory submission describing a drug's composition, manufacturing process, and quality controls.
Cleaning Validation
Cleaning Validation is foundational for process control, product quality, and inspection-readiness in manufacturing.
Corrective and Preventive Action(CAPA)
A systematic approach to identifying, investigating, and addressing the root causes of quality problems.
CQA(CQA)
CQA is foundational for process control, product quality, and inspection-readiness in manufacturing.
Critical Quality Attribute
Critical Quality Attribute is used to prevent quality failures and strengthen manufacturing control strategy.
De Novo Classification Request(De Novo)
A pathway for novel low-to-moderate risk medical devices that lack a predicate but do not require PMA-level review.
Design Controls
Systematic practices applied during product design and development to ensure devices meet user needs and intended uses.
DESIGN SPACE
DESIGN SPACE is used to support defensible premarket and postmarket device decisions.
Deviation
A departure from an approved procedure, specification, or established standard during manufacturing or testing.
DEVICE History RECORD
DEVICE History RECORD is used to support defensible premarket and postmarket device decisions.
DEVICE MASTER RECORD
DEVICE MASTER RECORD is used to support defensible premarket and postmarket device decisions.
DHF(DHF)
DHF is an important device-regulatory concept for pathway selection, evidence strategy, and compliance.
Genotoxic Impurity
Genotoxic Impurity is foundational for process control, product quality, and inspection-readiness in manufacturing.
Good Manufacturing Practice(GMP)
Regulations ensuring pharmaceutical products are consistently produced and controlled according to quality standards.
GUDID(GUDID)
GUDID is an important device-regulatory concept for pathway selection, evidence strategy, and compliance.
MAUDE(MAUDE)
MAUDE is used to support defensible premarket and postmarket device decisions.
Medical Device Reporting(MDR)
FDA mandatory reporting requirements for manufacturers and user facilities when medical devices may have caused or contributed to death or serious injury.
PMA Supplement
PMA Supplement is used to support defensible premarket and postmarket device decisions.
PPQ(PPQ)
PPQ is used to prevent quality failures and strengthen manufacturing control strategy.
Premarket Approval(PMA)
The FDA process for approving Class III high-risk medical devices based on clinical evidence of safety and effectiveness.
Process Validation(PV)
Documented evidence establishing high confidence that a process consistently produces a product meeting specifications.
Process Validation(PV)
Documented evidence that a process consistently produces a product meeting predetermined specifications and quality attributes.
Q1 Stability
Q1 Stability is used to prevent quality failures and strengthen manufacturing control strategy.
Quality by Design(QbD)
A systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding.
Quality System Regulation(QSR)
FDA regulations governing the methods and facilities used in the manufacture of medical devices.
Software AS A Medical DEVICE
Software AS A Medical DEVICE is used to support defensible premarket and postmarket device decisions.
Stability Testing(Stability)
Testing to determine how a drug product's quality changes over time under the influence of environmental factors.