Quality Control Requirements — Domain Applicability Crosswalk
Table of Contents
- Document Control (Metadata)
- 1. Purpose
- 2. Authority Model & Domain Classification
- 3. Domain Applicability Mapping
- 3.1 Marketing
- 3.2 Sales
- 3.3 Procurement
- 3.4 Material Readiness
- 3.5 Warehouse
- 3.6 Manufacturing
- 3.7 Packaging
- 3.8 Technical / Process Support Testing
- 3.9 Sanitation
- 3.10 Maintenance
- 3.11 Environmental Health & Safety
- 3.12 Information Technology
- 3.13 Training & Learning
- 3.14 Quality Unit / Quality Assurance
- 4. Document Control Note
Document Control (Metadata)
| Field | Value |
|---|---|
| Document ID | QC-REQ-IDX-DOMAIN-XWALK |
| Title | Quality Control Requirements — Domain Applicability Crosswalk |
| Document Type | Internal Applicability Crosswalk (QMS – Governance) |
| Authoritative Source | Quality Control Requirements Index (QC-REQ-IDX) |
| Owner | Quality Control Operations (QCO) (delegated under Quality Unit authority) |
| Approver | Quality Unit (QU) |
| Applies To | All Business Domains performing or supporting GMP-relevant activities |
| Version | v1.0 |
| Status | Draft |
| Effective Date | TBD (YYYY-MM-DD) |
| Controlled System of Record | QMS Controlled Repository (e.g., Jira/GitHub/EDMS) |
| Change Control | Per QMS Change Control (or Change Control ID: __________) |
| Retention | Per QMS Record Retention Policy |
Note: This crosswalk establishes applicability and execution boundaries only. It does not define, restate, or modify any QC-REQ requirements.
1. Purpose
Identifies Business Domains that execute or support Quality Control Requirements defined in QC-REQ-IDX. Establishes applicability and execution boundaries only. This document does not define, restate, or modify Quality Control requirements.
3. Domain Applicability Mapping
3.1 Marketing
Classification: QMS-Governed Domain
3.2 Sales
Classification: QMS-Governed Domain (Release-Restricted)
| QC-REQ ID | Quality Control Requirement Title |
|---|---|
| RX-SPEC-IDENT | Finished Product Identity Requirements |
| RX-SPEC-STRENGTH | Finished Product Strength (Potency) Requirements |
| RX-SPEC-PUREITY | Finished Product Purity / Contaminant Limits |
| RX-SPEC-COMPOSITION | Finished Product Composition Requirements |
| RX-SPEC-PHYSICAL | Physical & Organoleptic Characteristics |
| RX-SPEC-PACKAGING | Packaging Configuration & Acceptance Criteria |
| RX-SPEC-LABEL | QC-Relevant Labeling Requirements |
| RX-SPEC-STOREAGE | Storage & Handling Requirements |
| RX-SPEC-STABILITY | Stability & Shelf-Life Requirements |
| QC-DISP-002 | Release Decision Criteria |
3.3 Procurement
Classification: QC-Enabling Domain
| QC-REQ ID | Quality Control Requirement Title |
|---|---|
| QC-MAT-003 | Supplier Qualification Status Impact |
| QC-CHG-002 | Impact & Risk Assessment |
3.4 Material Readiness
Classification: QC-Executing Domain
| QC-REQ ID | Quality Control Requirement Title |
|---|---|
| QC-MAT-001 | Component Identity Verification |
| QC-MAT-002 | Component Purity & Contaminant Acceptance |
| QC-MAT-003 | Supplier Qualification Status Impact |
| QC-SAMP-001 | Sampling Plan Governance |
| QC-SAMP-002 | Lot Acceptance Decision Criteria |
| QC-ANL-004 | Outsourced Testing Governance |
| QC-DI-002 | Record Completeness & Traceability |
| QC-DISP-001 | Lot Disposition Authority |
| QC-REC-003 | Required QC Operations (MMR/BPR Review + Disposition + Release) |
3.5 Warehouse
Classification: QC-Executing Domain
| QC-REQ ID | Quality Control Requirement Title |
|---|---|
| QC-ENV-001 | Warehouse Environmental Conditions |
| QC-ENV-004 | Temperature-Controlled Storage |
| QC-ENV-005 | Retained Sample Storage |
| QC-MAT-004 | Material Storage & Handling Condition |
| QC-DISP-003 | Rejection & Quarantine Governance |
| QC-OPS-003 | Holding & Distribution Governance |
| QC-RET-001 | Returned Dietary Supplement Governance |
3.6 Manufacturing
Classification: QC-Executing Domain
| QC-REQ ID | Quality Control Requirement Title |
|---|---|
| QC-ENV-002 | Production Environmental Conditions |
| QC-IPC-002 | In-Process Acceptance Criteria |
| QC-IPC-004 | In-Process Deviation Response |
| QC-OPS-001 | Manufacturing Operations Governance |
| QC-REC-002 | Batch Production Record (BPR) Governance |
3.7 Packaging
Classification: QC-Executing Domain
| QC-REQ ID | Quality Control Requirement Title |
|---|---|
| QC-ENV-003 | Packaging Environmental Conditions |
| QC-MAT-005 | Packaging Component Quality |
| QC-IPC-002 | In-Process Acceptance Criteria |
| QC-OPS-002 | Packaging & Labeling Operations Governance |
| QC-REC-002 | Batch Production Record (BPR) Governance |
3.8 Technical / Process Support Testing
Classification: QC-Enabling Domain
| QC-REQ ID | Quality Control Requirement Title |
|---|---|
| QC-ANL-001 | Analytical Method Suitability |
| QC-ANL-002 | Instrument & System Suitability |
| QC-ANL-003 | Measurement Uncertainty Impact |
| QC-IPC-001 | Critical Process Parameter Governance |
| QC-IPC-003 | Process Monitoring & Trending |
3.9 Sanitation
Classification: QC-Enabling Domain
| QC-REQ ID | Quality Control Requirement Title |
|---|---|
| QC-FAC-002 | Facility Cleanliness |
| QC-FAC-003 | Facility Drain Design & Maintenance |
| QC-UTIL-003 | Wastewater & Drainage Systems |
3.10 Maintenance
Classification: QC-Enabling Domain
| QC-REQ ID | Quality Control Requirement Title |
|---|---|
| QC-UTIL-001 | Compressed Air Quality |
| QC-UTIL-002 | Water Quality Classification |
| QC-UTIL-004 | Backflow & Cross-Connection Prevention |
| QC-CHG-003 | Validation & Requalification Governance |
3.11 Environmental Health & Safety
Classification: QC-Enabling Domain
| QC-REQ ID | Quality Control Requirement Title |
|---|---|
| QC-FAC-001 | GMP Area Classification & Zoning |
| QC-UTIL-003 | Wastewater & Drainage Systems |
| QC-CHG-002 | Impact & Risk Assessment |
3.12 Information Technology
Classification: QC-Enabling Domain
| QC-REQ ID | Quality Control Requirement Title |
|---|---|
| QC-DI-004 | Electronic Record & System Governance |
| QC-CHG-003 | Validation & Requalification Governance |
3.13 Training & Learning
Classification: QMS-Governed / QC-Enabling Domain
| QC-REQ ID | Quality Control Requirement Title |
|---|---|
| QC-CHG-004 | Change Effectiveness Review |
3.14 Quality Unit (QU) – QC Authorization Authority
Classification: Classification: QC-Authorizing Authority (Non-Delegable)
| QC-REQ ID | Quality Control Requirement Title |
|---|---|
| QC-REC-001 | Master Manufacturing Record (MMR) Governance |
| QC-REC-002 | Batch Production Record (BPR) Governance |
| QC-REC-003 | Required QC Operations (MMR/BPR Review + Disposition + Release) |
| QC-REC-004 | Record Retention & FDA Availability Governance |
| QC-COMP-001 | Product Complaint Governance |