GMP & Quality Glossary
This glossary defines key GMP and quality system terms used across VerethiQ.
Each definition is concise, operational, and aligned with regulatory expectations.
Use this as a reference point while navigating the Knowledge Hub.
A
ALCOA+
Framework defining data integrity expectations: Attributable, Legible, Contemporaneous, Original, Accurate (+ Complete, Consistent, Enduring, Available).
ASL (Approved Supplier List)
Controlled list of suppliers authorized for use.
Attribute
A measurable characteristic or property of a material, process, product, or system that can be evaluated or controlled.
Audit
A systematic, independent evaluation to determine whether activities comply with defined procedures, regulations, and standards.
Auditee
The function or organization being audited.
Auditor
The individual or team performing the audit.
C
Calibration
A documented process for confirming that an instrument or measurement device produces results within specified limits.
CAPA (Corrective and Preventive Action)
A structured process to address root causes of deviations and prevent recurrence.
CFR (Code of Federal Regulations)
The codified rules and regulations issued by U.S. federal agencies, including FDA regulations governing pharmaceutical manufacturing and quality systems.
CMO (Contract Manufacturing Organization)
External manufacturer contracted to produce products.
Competency
The demonstrated ability to perform a task correctly and consistently based on knowledge, skills, and experience.
Control
A procedural, technical, or organizational measure used to maintain a process within defined limits.
Correction
An action taken to address a detected issue or nonconformance without necessarily addressing its underlying cause.
CPP (Critical Process Parameter)
A process parameter whose variability may affect a critical quality attribute and therefore requires monitoring or control.
CPV (Continued Process Verification)
Ongoing assurance during routine production that processes remain stable and capable.
CQA (Critical Quality Attribute)
A physical, chemical, biological, or microbiological characteristic that must remain within defined limits to ensure product quality.
CSV (Computer System Validation)
Ensuring computerized systems perform reliably, securely, and as intended.
D
Deviation
A departure from an approved procedure, specification, or expected result.
E
Escalation
A formal process for raising issues to higher levels of authority based on risk, impact, or decision requirements.
Execution
Operational activities performed within defined processes.
F
FDA (Food and Drug Administration)
The United States regulatory authority responsible for overseeing the safety, efficacy, quality, and security of drugs, biologics, medical devices, and other regulated products.
FMEA (Failure Mode and Effects Analysis)
A structured risk assessment method used to identify potential failure modes, their causes, and their potential effects.
G
GDP (Good Documentation Practices)
Standards governing how records are created, corrected, and maintained to ensure integrity and traceability.
Governance
The framework of oversight, accountability, and decision-making used to ensure processes remain controlled and compliant.
GMP (Good Manufacturing Practice)
Regulatory framework ensuring products are consistently produced and controlled to quality standards.
H
HACCP (Hazard Analysis and Critical Control Points)
A risk management methodology used to identify hazards and establish controls at points critical to preventing or reducing risk.
HVAC (Heating, Ventilation, and Air Conditioning)
Facility systems used to control temperature, humidity, airflow, pressure differentials, and air cleanliness within manufacturing environments.
I
ICH (International Council for Harmonization)
An organization that develops internationally harmonized guidelines for pharmaceutical quality, safety, efficacy, and lifecycle management.
Inspection
A regulatory authority’s formal evaluation of compliance (e.g. GMP inspection).
Investigation
A structured process to determine root cause of a deviation and assess impact.
IPC (In-Process Control)
Checks performed during manufacturing to ensure process remains within limits.
IQC (Incoming Quality Control)
Inspection and testing of incoming materials before use.
L
Lifecycle
The sequence of stages through which a process, system, product, or document is planned, implemented, maintained, and improved.
O
Observation
A documented statement of non-conformance or potential risk identified during an audit or inspection.
OJT (On-the-Job Training)
Training conducted through supervised performance of actual job tasks in the work environment.
OOS (Out-of-Specification)
Result that falls outside predefined acceptance criteria.
OOT (Out-of-Trend)
Result within specification but deviating from expected trend.
Oversight
Independent or supervisory review of activities to ensure they are performed as intended and remain compliant.
P
PIC/S (Pharmaceutical Inspection Co-operation Scheme)
An international arrangement among regulatory authorities that promotes harmonization of GMP standards and inspection practices.
PQS (Pharmaceutical Quality System)
A QMS aligned with ICH Q10 principles, integrating lifecycle management, risk management, and continual improvement.
Prevention
Action taken to eliminate the cause of a potential issue before the issue occurs.
Q
QMS (Quality Management System)
A structured system of processes, procedures, and responsibilities to ensure consistent quality and compliance.
QRM (Quality Risk Management)
A systematic process for assessing, controlling, communicating, and reviewing risks to product quality.
Qualification
Documented verification that facilities, equipment, utilities, or systems are suitable for their intended use.
R
RCA (Root Cause Analysis)
Structured methodologies (e.g. 5-Why, Fishbone) used to identify true causes of failure.
Robustness
The ability of a process or method to perform consistently despite small variations in operating conditions.
RPN (Risk Priority Number)
A numerical score used in FMEA to prioritize risks based on severity, occurrence, and detectability ratings.
S
SOP (Standard Operating Procedure)
An approved, controlled document describing how to perform a specific task.
Specification
Defined acceptance criteria for materials or products.
T
Trending
Analysis of data over time to identify patterns, shifts, or emerging risks.
V
Validation
Documented evidence that a process, system, or method performs as intended consistently.
Verification
Confirmation that specified requirements have been met.
W
WHO (World Health Organization)
An international public health agency that publishes guidance and standards, including GMP-related expectations used in many regions worldwide.
Y
Yield
Amount of product produced compared to expected quantity.