Quality Unit (QU)
[ Final Quality Authority • Regulatory Decisions • Independent Oversight ]
Authority to approve or reject components, in-process materials, labels, and finished dietary supplements
Authority to approve or reject components, in-process materials, labels, and finished dietary supplements
Authority Applied Using
Quality Control (QC – Control Framework)
[ Acceptance criteria • Specifications • Release rules ]
Control framework defining quality requirements — not an Org role or function
• Environmental & facility • Material & component • Sampling & acceptance
• Analytical & measurement system • Process & In-process
• Stability & lifecycle • Disposition & release
• Data integrity & records • Change & continuous improvement
Control framework defining quality requirements — not an Org role or function
• Environmental & facility • Material & component • Sampling & acceptance
• Analytical & measurement system • Process & In-process
• Stability & lifecycle • Disposition & release
• Data integrity & records • Change & continuous improvement
Quality Management System (QMS)
[ Governance Framework • Process Structure • Effectiveness Oversight ]
System-level governance framework — not an Org role or function
• Supplier qualification • Approved supplier list
• Material status control (quarantine / released / rejected)
• Records management & data integrity (21 CFR 111 Subpart P • ALCOA+)
System-level governance framework — not an Org role or function
• Supplier qualification • Approved supplier list
• Material status control (quarantine / released / rejected)
• Records management & data integrity (21 CFR 111 Subpart P • ALCOA+)
Operational Execution
Illustrative Operational (GMP & Direct Support) Process Families
[ Executed by Operations • Governed by QMS • Independently Overseen by QA ]
QA provides independent quality oversight; QA does NOT execute GMP operations.
WH – Warehousing
Receipt, storage, handling, and distribution of materials
PROD – Production
Manufacturing and processing of GMP products
PKG – Packaging
Labeling, packaging, and final presentation of product
SAN – Sanitation
Cleaning, sanitation, and contamination control
Deviation Identified During Operations
Quality System Process Families (Administered by QA under QU Authority)
[ Independent quality system governance - QA does NOT execute GMP operations ]
Deviation & Quality Event Lifecycle • System Execution • Escalation • Oversight Enablement
Deviation & Quality Event Lifecycle • System Execution • Escalation • Oversight Enablement
Deviation Lifecycle Management
Identification, documentation, investigation, and lifecycle oversight of deviations
Identification, documentation, investigation, and lifecycle oversight of deviations
Quality Events
Formal event classification, assessment, and escalation
Formal event classification, assessment, and escalation
CAPA Management
Root cause analysis, corrective and preventive actions
Root cause analysis, corrective and preventive actions
Change Management
Controlled evaluation, approval, and implementation of change
Controlled evaluation, approval, and implementation of change
Audit Management
Assess compliance and quality system effectiveness
Assess compliance and quality system effectiveness
Training & Qualification
Ensure personnel are trained, qualified, and competent
Ensure personnel are trained, qualified, and competent
Operations execute GMP activities; QA executes the quality system; QMS governs both under independent QU authority.
Quality Management System (QMS) – Governance Framework
The Quality Management System (QMS) provides the formal governance framework for GMP-relevant activities. It establishes structured processes, documentation controls, and system-level oversight mechanisms to ensure consistent and compliant execution.
- Deviation, investigation, and lifecycle management
- CAPA governance and effectiveness verification
- Change control evaluation and implementation oversight
- Supplier qualification and approved supplier governance
- Records management and data integrity controls
- Audit and continuous improvement processes
The QMS governs both operational execution and Quality Control activities under independent Quality Unit authority. It does not independently establish product acceptance criteria or make disposition decisions.