This document establishes the Quality Control Requirements Index (QC-REQ-IDX) as the authoritative, QMS-level source of QC rules, acceptance criteria, limits, and decision thresholds governing GMP-relevant activities.
The requirements defined in this index constitute the formal QC rules under which product, material, process, facility, and data quality decisions are made. These rules are established and approved by Quality Control Operations (QCO) and are executed within the Quality Management System (QMS).
QC requirements may be executed by trained personnel performing the activity, including operators, technicians, and analysts, provided that acceptance criteria and decision thresholds are predefined, documented, and controlled. Organizational independence is not required for execution of QC requirements.
Independence is applied at the level of review, evaluation, escalation, and disposition, in accordance with the QMS. Results that meet acceptance criteria may proceed as defined, while results that exceed, violate, or trend toward defined limits require escalation and Quality Event handling per QMS procedures executed by Quality Assurance (QA).
This index enables any QC decision made during operations to be directly traceable to an explicit, approved requirement. If a quality-related decision cannot be mapped to a requirement within this index, that decision is considered uncontrolled and the requirement must be formally defined by QCO prior to system lock under the QMS.
Acceptance criteria, limits, specifications, and decision thresholds governing GMP-relevant activities are defined directly within this document where practical. Standalone specification documents that previously contained only restated limits may be consolidated into this index to establish a single authoritative source and reduce reconciliation risk.
Quality Control Requirements (QC-REQ) are intentionally divided into two distinct classes to preserve clarity of ownership, appropriate change control, and inspection readiness:
Product-Specific QC-REQ define what quality attributes must be met for an individual product. These requirements are approved and controlled by QCO and are implemented through QA-approved Product Specifications maintained under product-level change control.
| QC-REQ Category | Requirement Type | Authoritative Source Document |
|---|---|---|
| Finished product identity | Release acceptance criteria | Finished Product Specification (Capsule) |
| Finished product strength | Declared ingredient limits | Finished Product Specification (Capsule) |
| Finished product purity | Contaminant limits | Finished Product Specification (Capsule) |
| Finished product composition | Formula & excipient constraints | Finished Product Specification (Capsule) |
| Physical / appearance | Visual & physical acceptance criteria | Finished Product Specification (Capsule) |
| Packaging configuration | Suitability & acceptance criteria | Finished Product Specification (Capsule) |
| Labeling (QC-relevant) | Content & claim constraints | Finished Product Specification (Capsule) |
| Storage & handling | Temperature & RH limits | Finished Product Specification (Capsule) |
| Stability | Shelf-life criteria | Finished Product Specification (Capsule) + Stability Protocols |
System-Level QC-REQ apply uniformly across products and define Quality Control governance, authority, escalation, and decision-making rules. These requirements are owned and approved by QCO and maintained under system-level change control.
Linked specification documents are retained for historical reference only. Acceptance criteria and governance requirements are authoritative as defined within this index.
| QC-REQ ID | QC-REQ Category | Requirement Type |
|---|---|---|
| QC-ENV-001 | Warehouse environmental conditions |
Temperature and relative humidity acceptance criteria governing
GMP-designated warehouse storage areas:
|
| QC-ENV-002 | Production environmental conditions |
Temperature and relative humidity acceptance criteria governing
GMP-designated production and packaging areas:
|
| QC-ENV-003 | Packaging environmental conditions |
Temperature and relative humidity acceptance criteria governing
GMP-designated production and packaging areas:
|
| QC-ENV-004 | Temperature-controlled storage |
Acceptance criteria governing refrigerated, frozen, or otherwise
temperature-controlled GMP storage conditions:
|
| QC-ENV-005 | Retained sample storage |
Environmental acceptance criteria governing retained sample storage conditions:
|
| QC-FAC-001 | GMP area classification & zoning |
Classification, zoning, and segregation requirements for
GMP-designated facility areas
(Facility Classification & Zoning Specification) |
| QC-FAC-002 | Facility cleanliness |
Acceptance criteria defining cleanliness expectations for
GMP-designated facility areas
(Facility Cleanliness Acceptance Specification) |
| QC-FAC-003 | Facility drain design & maintenance |
Acceptance criteria governing drain placement, slope, cleanability,
trapping, odor control, pest prevention, and maintenance of drains
located in GMP-designated facility areas
(Facility Drain Design & Maintenance Specification) |
| QC-UTIL-001 | Compressed air quality |
Quality classification and acceptance criteria for compressed air used
in GMP-relevant operations:
|
| QC-UTIL-002 | Water quality classification |
Quality classification and acceptance criteria for water used in
GMP-relevant operations:
|
| QC-UTIL-003 | Wastewater & drainage systems |
Governance requirements for wastewater, sewer, and drainage systems
serving GMP-designated areas, including:
|
| QC-UTIL-004 | Backflow & cross-connection prevention |
Governance requirements for prevention of backflow and cross-connection
between potable water, process utilities, and wastewater systems, including:
|
| QC-REQ ID | QC-REQ Category | Requirement Type |
|---|---|---|
| QC-MAT-001 | Component identity verification |
Acceptance criteria and decision requirements for verification of
component and raw material identity prior to GMP use
(Component Identity Verification Specification) |
| QC-MAT-002 | Component purity & contaminant acceptance |
Acceptance criteria governing purity, contaminant limits, and
suitability of components and raw materials for GMP use
(Component Purity & Contaminant Acceptance Specification) |
| QC-MAT-003 | Supplier qualification status impact |
Decision rules defining how supplier qualification and performance
status impacts material acceptance and usability
(Supplier Qualification Status Impact Specification) |
| QC-MAT-004 | Material storage & handling condition |
Acceptance criteria governing material condition, container integrity,
segregation, and suitability during storage and handling
(Material Storage & Handling Acceptance Specification) |
| QC-MAT-005 | Packaging component quality |
Acceptance criteria governing quality, suitability, and condition of
packaging components prior to GMP use
(Packaging Component Quality Acceptance Specification) |
| QC-REQ ID | QC-REQ Category | Requirement Type |
|---|---|---|
| QC-SAMP-001 | Sampling plan governance |
System-level requirements defining how sampling plans are established,
approved, and governed for GMP materials and products
(Sampling Plan Governance Specification) |
| QC-SAMP-002 | Lot acceptance decision criteria |
Acceptance criteria and decision rules governing lot acceptance,
rejection, or further evaluation based on sampling results
(Lot Acceptance Decision Specification) |
| QC-SAMP-003 | Sampling representativeness |
Requirements ensuring samples collected are representative of the
lot, batch, or population being evaluated
(Sampling Representativeness Specification) |
| QC-SAMP-004 | Reduced / skip-lot sampling |
Conditions under which reduced, skip-lot, or alternative sampling
schemes may be applied
(Reduced & Skip-Lot Sampling Specification) |
| QC-REQ ID | QC-REQ Category | Requirement Type |
|---|---|---|
| QC-ANL-001 | Analytical method suitability |
Acceptance criteria governing the suitability of analytical methods
used to generate GMP-relevant test results
(Analytical Method Suitability Specification) |
| QC-ANL-002 | Instrument & system suitability |
Acceptance criteria governing the suitability, readiness, and reliability
of instruments and analytical systems used for GMP testing
(Instrument & System Suitability Specification) |
| QC-ANL-003 | Measurement uncertainty impact |
Requirements governing how measurement uncertainty is considered
when evaluating analytical results against acceptance criteria
(Measurement Uncertainty Impact Specification) |
| QC-ANL-004 | Outsourced testing governance |
Governance requirements defining acceptance and control of analytical
results generated by external laboratories
(Outsourced Testing Governance Specification) |
| QC-REQ ID | QC-REQ Category | Requirement Type |
|---|---|---|
| QC-IPC-001 | Critical process parameter governance |
Governance requirements defining identification, control, and oversight
of critical process parameters impacting product quality
(Critical Process Parameter Governance Specification) |
| QC-IPC-002 | In-process acceptance criteria |
Acceptance criteria governing in-process tests and evaluations used
to support continued processing decisions
(In-Process Acceptance Criteria Specification) |
| QC-IPC-003 | Process monitoring & trending |
Requirements governing monitoring, trending, and evaluation of
process performance and variability
(Process Monitoring & Trending Specification) |
| QC-IPC-004 | In-process deviation response |
Decision requirements governing response, escalation, and control
of in-process deviations impacting product quality
(In-Process Deviation Response Specification) |
| QC-REQ ID | QC-REQ Category | Requirement Type |
|---|---|---|
| QC-STAB-001 | Stability program governance |
Governance requirements defining establishment, approval, and oversight
of stability programs for GMP products
(Stability Program Governance Specification) |
| QC-STAB-002 | Retained sample lifecycle |
Requirements governing retention, storage, use, and disposition of
retained samples throughout the product lifecycle
(Retained Sample Lifecycle Specification) |
| QC-STAB-003 | Shelf life assignment |
Acceptance criteria governing assignment, extension, and maintenance
of product shelf life and expiry
(Shelf Life Assignment Specification) |
| QC-STAB-004 | Lifecycle trending & review |
Requirements governing lifecycle review and trending of stability,
complaints, and quality performance data
(Lifecycle Trending & Review Specification) |
| QC-REQ ID | QC-REQ Category | Requirement Type |
|---|---|---|
| QC-DISP-001 | Lot disposition authority |
Governance requirements defining authority, responsibility, and accountability
for disposition decisions of GMP lots and batches
(Lot Disposition Authority Specification) |
| QC-DISP-002 | Release decision criteria |
Acceptance criteria governing final release decisions for GMP products
prior to distribution
(Release Decision Criteria Specification) |
| QC-DISP-003 | Rejection & quarantine governance |
Requirements governing identification, segregation, and control of
rejected or nonconforming materials and products
(Rejection & Quarantine Governance Specification) |
| QC-DISP-004 | Rework & reprocessing governance |
Governance requirements defining evaluation, approval, and control of
rework or reprocessing activities
(Rework & Reprocessing Governance Specification) |
| QC-DISP-005 | Conditional release governance |
Requirements governing conditional or limited release of product
under defined risk-based controls
(Conditional Release Governance Specification) |
| QC-DISP-006 | Microbiological acceptance |
Acceptance criteria governing microbiological quality of finished
products prior to release
(Microbiological Acceptance Specification) |
| QC-DISP-007 | Chemical acceptance |
Acceptance criteria governing chemical and contaminant limits of
finished products prior to release
(Chemical Acceptance Specification) |
| QC-DISP-008 | Identity & composition acceptance |
Acceptance criteria governing finished product identity and
composition conformance
(Finished Product Specification) |
| QC-DISP-009 | Potency / strength acceptance |
Acceptance criteria governing potency or strength claims where
applicable prior to product release
(Potency Acceptance Specification) |
| QC-REQ ID | QC-REQ Category | Requirement Type |
|---|---|---|
| QC-DI-001 | Data integrity governance |
Governance requirements ensuring data is attributable, legible,
contemporaneous, original, and accurate throughout its lifecycle
(Data Integrity Governance Specification) |
| QC-DI-002 | Record completeness & traceability |
Requirements ensuring GMP records are complete, traceable, and
reconstructable from raw data to final decision
(Record Completeness & Traceability Specification) |
| QC-DI-003 | Document control governance |
Governance requirements defining creation, approval, revision,
distribution, and archival of controlled GMP documents
(Document Control Governance Specification) |
| QC-DI-004 | Electronic record & system governance |
Governance requirements for electronic systems generating,
storing, or managing GMP data and records
(Electronic Record & System Governance Specification) |
| QC-DI-005 | Data review & approval governance |
Requirements governing independent review, approval, and
authorization of GMP data and quality records
(Data Review & Approval Governance Specification) |
| QC-REQ ID | QC-REQ Category | Requirement Type |
|---|---|---|
| QC-CHG-001 | Change control governance |
Governance requirements defining evaluation, approval, implementation,
and documentation of GMP-impacting changes
(Change Control Governance Specification) |
| QC-CHG-002 | Impact & risk assessment |
Requirements governing identification, evaluation, and documentation
of quality, regulatory, and business risk associated with change
(Impact & Risk Assessment Specification) |
| QC-CHG-003 | Validation & requalification governance |
Governance requirements defining when validation, verification,
or requalification is required following change
(Validation & Requalification Governance Specification) |
| QC-CHG-004 | Change effectiveness review |
Requirements governing post-implementation review to confirm
changes achieved intended outcomes without adverse impact
(Change Effectiveness Review Specification) |
| QC-CI-001 | Continuous improvement governance |
Governance requirements ensuring systematic identification,
prioritization, and implementation of quality improvements
(Continuous Improvement Governance Specification) |