Section 1 - Family Summary

This Family inherits the governance requirements defined in the Unified Governance Manual (SOP-QMS-GOV), including the Quality Manual, Risk Management Program (RMP), Internal Audit Program (IAP), and Material Review Board (MRB) governance (SOP-QA-MRB). All PKG responsibilities and WINs must align with these L2 authorities.

The Packaging (PKG) Process Family governs the controlled setup, execution, labeling, inspection, and cleaning of packaging operations for finished dietary supplements and intermediate products. PKG ensures that products are correctly packaged and accurately labeled, free from mix-ups or contamination, and supported by complete and traceable documentation.

PKG provides WHAT-level governance for:

Packaging line setup and configuration
Label issuance, verification, and control
Component inspection and verification
In-process checks during packaging
Reconciliation of packaging components
Controlled cleaning of packaging equipment and areas
Prevention of mix-ups and cross-contact

Packaging operations are critical because 21 CFR 111 requires manufacturers to:

Verify packaging and labeling components before use (§111.70(f))
Confirm label accuracy and suitability (§111.75(e–i))
Control packaging and labeling operations (§111.415–§111.430)
Maintain label reconciliation records (§111.415)
Ensure QC oversight (§111.120–§111.125)

NSF/ANSI 455-2 reinforces these requirements through:

Label verification and version control
Component inspection and suitability checks
Foreign-material prevention and environmental control
Equipment readiness and calibration/maintenance expectations
Documentation supporting packaging integrity

Key PKG risk themes include:

Mislabeling or label mix-ups
Use of incorrect or unapproved label versions
Incorrect packaging component selection
Foreign-material introduction during setup or packaging
Incomplete reconciliation of labels, components, or shippers
Improper equipment cleaning or configuration
Cross-contact or contamination on the packaging line

PKG requires strong cross-functional interaction with:

Production (PROD): Handoff and accountability of bulk product
Warehouse (WH): Delivery of packaging components and labeling materials
Quality Assurance (QA): Line clearance, label checks, release
Quality Control (QCL): Sampling and in-process inspections
Maintenance (MAINT): Packaging equipment function and readiness
Sanitation (SAN): Cleaning and environmental control of packaging lines

Risk Tier Classification: HIGH. Packaging is classified as HIGH risk because failures in label control, component selection, or reconciliation can directly create misbranded, adulterated, or unsafe products. Packaging issues are among the most frequently cited FDA and NSF audit observations under 21 CFR 111 and NSF/ANSI 455-2.

Section 2 - Purpose, Scope & Regulatory and QC Anchors

This section defines the WHAT-level purpose, operational scope, regulatory anchors, and Quality Control (QC) requirement anchors for each Packaging (PKG) SOP in the frozen hierarchy. Packaging operates as a QC-Executing domain and directly executes defined quality controls related to packaging component quality, environmental conditions, and in-process acceptance during packaging operations.

SOP ID	SOP Title	Purpose (Control Intent)	Scope (Operational Boundary)	QC Requirement Anchors (Executed by PKG)	Regulatory Anchors
SOP-PKG-SETUP	Packaging Line Setup	Establishes requirements for preparing the packaging line to ensure only correct materials, labels, tools, and equipment are present before packaging operations begin.	Applies to pre-run setup, verification of components, equipment readiness checks, and confirmation that unrelated materials are removed from the packaging area. Excludes sanitation.	QC-MAT-005 (Packaging component quality) QC-ENV-003 (Packaging environmental conditions)	21 CFR: 111.70(f), 111.110, 111.415(a). NSF/ANSI 455-2: 4.6.3, 4.7, 4.4.2.
SOP-PKG-LABEL	Label Control & Verification	Defines requirements to ensure labels are correct, approved, verified, and applied in a manner that maintains identity, traceability, and regulatory compliance.	Applies to label version verification, component checks, label accountability, and ensuring only approved labels and inserts are present. Excludes packaging execution.	QC-MAT-005 (Packaging component quality)	21 CFR: 111.410–111.430, 111.75(e–h), 111.415(b). NSF/ANSI 455-2: 4.6.1, 4.6.3, 4.10.
SOP-PKG-PACK	Packaging Operations	Establishes WHAT-level requirements for performing packaging activities in alignment with approved packaging records to prevent mix-ups, contamination, and labeling errors.	Applies to component verification during use, label application, in-process packaging checks, lot-level documentation, and reconciliation of used packaging components. Excludes setup and cleaning.	QC-IPC-002 (In-process acceptance criteria) QC-ENV-003 (Packaging environmental conditions)	21 CFR: 111.415–111.427, 111.260(k), 111.110, 111.27. NSF/ANSI 455-2: 4.1.2–4.1.3, 4.6.3, 4.7.
SOP-PKG-CLEAN	Packaging Area Cleaning	Defines requirements to ensure packaging areas, surfaces, and equipment are free of residue, contamination, and foreign material before and after packaging runs.	Applies to cleaning of packaging equipment, counters, conveyors, tables, and environmental surfaces used during packaging operations. Excludes sanitation activities governed by the SAN Family.	QC-ENV-003 (Packaging environmental conditions)	21 CFR: 111.27(d–e), 111.113, 111.360. NSF/ANSI 455-2: 4.7, 4.8, 4.4.2.

Packaging (PKG) operates as a QC-Executing domain. QC requirement anchors listed in this section are ordered to reflect execution logic and identify Quality Control requirements that are directly executed through Packaging SOPs. Ordering does not imply priority, dependency, or Quality Control decision authority. Final acceptance, deviation disposition, and release authority remains with the Quality Unit in accordance with the enterprise QMS.

Section 3 - General Training Requirements

The following WHAT-level training requirements apply to all personnel who prepare, execute, support, or document Packaging (PKG) activities. Training expectations are grouped by governing SOP to improve clarity, traceability, and audit alignment. These requirements establish foundational GMP behaviors and do not include HOW-level task instructions or Work Instructions.

SOP-PKG-SETUP — Packaging Line Setup

Personnel must understand that packaging lines must be cleared of all unrelated materials prior to setup.
Personnel must understand verification requirements for correct packaging components, tools, and equipment.
Personnel must understand mix-up prevention principles applied during line setup.
Personnel must understand how to identify and escalate unidentified, incorrect, or unapproved components.
Personnel must understand environmental and cleanliness expectations prior to initiating packaging operations.

SOP-PKG-LABEL — Label Control & Verification

Personnel must understand label control principles, including approval status, version control, and reconciliation.
Personnel must understand how to verify correct label identity, alignment, and lot applicability.
Personnel must understand label segregation and accountability requirements.
Personnel must understand the risks associated with mislabeling, misbranding, or use of outdated labels.
Personnel must understand escalation requirements for label discrepancies or mismatches.

SOP-PKG-PACK — Packaging Operations

Personnel must understand that only approved packaging components may be used during execution.
Personnel must understand in-process packaging check expectations and their role in preventing errors.
Personnel must understand documentation requirements for packaging activities and component usage.
Personnel must understand how improper handling or sequencing can result in mix-ups or traceability failures.
Personnel must understand escalation requirements for deviations, abnormal conditions, or in-process failures.

SOP-PKG-CLEAN — Packaging Area Cleaning

Personnel must understand cleaning verification expectations before and after packaging runs.
Personnel must understand contamination- and residue-prevention principles applicable to packaging areas.
Personnel must understand how inadequate cleaning can impact subsequent packaging operations.
Personnel must understand documentation requirements associated with cleaning verification.

Cross-SOP Foundational GMP Expectations

Personnel must understand ALCOA+ principles and apply them to all packaging documentation and records.
Personnel must understand that only approved and controlled documents may be used.
Personnel must understand how Packaging activities interact with Warehouse, Production, QA, QC, and Sanitation.
Personnel must understand that access to packaging areas is restricted to trained and authorized individuals.
Personnel must understand how to identify and escalate deviations, discrepancies, or abnormal conditions.

Section 4 - Unified Responsibility & High-Level Control Mapping

This section defines WHAT-level responsibilities and high-level controls for all L0-approved roles that perform, supervise, support, or influence Packaging (PKG) activities. This section does not include procedural HOW-to content and does not reference SOPs, WINs, or FORMs.

Role	Primary Responsibilities (WHAT)	High-Level Controls (WHAT Requirements)
Packaging Operator	• Perform packaging activities in alignment with approved requirements. • Maintain identity, segregation, and control of packaging components and labels. • Identify discrepancies in labels, components, or area conditions requiring escalation. • Document packaging checks and component usage accurately and contemporaneously. • Maintain cleanliness and organization of packaging areas during operations.	• Follow identity and traceability controls for packaging components. • Maintain compliance with in-process packaging verification expectations. • Apply contamination-prevention boundaries for all contact surfaces and components. • Ensure packaging documentation meets ALCOA+ principles. • Maintain separation of approved and unapproved materials.
Packaging Supervisor	• Oversee packaging operations to ensure compliance with component, labeling, and traceability requirements. • Ensure personnel follow mix-up prevention and segregation expectations. • Identify and escalate component or label discrepancies affecting packaging integrity. • Maintain oversight of packaging documentation and reconciliation accuracy. • Coordinate component readiness with Warehouse and Production.	• Validate that packaging areas meet readiness requirements before operations. • Ensure packaging checks are performed and documented appropriately. • Maintain oversight of label and component accountability controls. • Ensure escalation pathways for discrepancies are followed. • Support reconciliation controls required for compliant release.
Warehouse Operator	• Deliver packaging components to the line in alignment with status and identification requirements. • Maintain segregation of approved, quarantined, and rejected components. • Identify labeling or component issues requiring escalation. • Document component issuance and return accurately. • Maintain clean, organized staging locations for packaging materials.	• Follow controls preventing mix-ups or incorrect component issuance. • Maintain traceability for all component movements supporting packaging. • Prevent unauthorized introduction of non-approved components. • Ensure staging aligns with environmental and cleanliness expectations. • Maintain ALCOA+-compliant issuance documentation.
Warehouse Supervisor	• Oversee component staging, issuance, and return supporting packaging. • Ensure operators follow segregation and component-control expectations. • Monitor staging accuracy and escalate discrepancies. • Coordinate component readiness with Packaging schedules. • Maintain records supporting label and component accountability.	• Validate that staged components meet identity and status requirements. • Maintain oversight of mix-up prevention controls for label and packaging materials. • Ensure traceability for all component deliveries. • Maintain accurate issuance documentation supporting reconciliation. • Support risk-based escalation for component deficiencies.
Production Operator	• Transfer bulk product to the packaging area in alignment with identity and segregation expectations. • Identify abnormal conditions affecting product suitability for packaging. • Maintain correct documentation for batch handoff to Packaging. • Support traceability of in-process and bulk product before packaging. • Maintain cleanliness and organization during product movement.	• Follow product identification and segregation controls during transfer. • Maintain controls preventing contamination of bulk product. • Ensure batch-handoff documentation remains complete and accurate. • Escalate discrepancies affecting packaging readiness. • Maintain traceability for product movement into PKG areas.
Production Supervisor	• Coordinate bulk product readiness for packaging. • Ensure product documentation and identification support PKG requirements. • Identify and escalate product or documentation conditions impacting packaging start. • Align production completion with packaging scheduling needs. • Provide oversight of material readiness for transfer to PKG.	• Validate that bulk product meets identity and release requirements before PKG. • Maintain oversight of product segregation and staging. • Ensure PKG-related documentation is complete and aligned. • Support escalation pathways for issues affecting packaging. • Maintain accuracy of transfer records supporting traceability.
Maintenance Technician	• Maintain packaging equipment in suitable condition for use. • Identify equipment conditions that may affect labeling or packaging integrity. • Support troubleshooting and corrective actions impacting PKG areas. • Prevent maintenance activities from introducing contamination. • Escalate equipment conditions affecting packaging readiness.	• Maintain equipment suitability and safe function for PKG operations. • Ensure maintenance documentation supports PKG readiness. • Apply contamination-prevention controls during maintenance. • Maintain boundaries for equipment access in PKG zones. • Ensure issues impacting PKG equipment are resolved promptly.
Facilities / Utilities Technician	• Maintain facility conditions that support controlled packaging operations. • Identify environmental or structural risks affecting packaging or labeling integrity. • Maintain airflow, temperature, and environmental controls for PKG zones. • Support facility-related remediation impacting PKG. • Escalate facility deficiencies affecting packaging suitability.	• Maintain environmental conditions required for compliant PKG operations. • Ensure utilities support packaging equipment and area requirements. • Maintain ALCOA+ documentation reflecting facility readiness. • Prevent facility work from introducing contamination. • Support corrective actions affecting PKG environments.
Sanitation Technician	• Maintain cleanliness of packaging areas to support contamination-prevention expectations. • Identify sanitation concerns impacting PKG readiness. • Support removal of debris and residues affecting component or product integrity. • Maintain sanitation documentation associated with PKG zones. • Escalate cleanliness issues affecting packaging suitability.	• Apply contamination-prevention expectations during sanitation. • Maintain documentation supporting PKG readiness post-cleaning. • Follow boundaries for performing sanitation in PKG zones. • Protect materials and components during sanitation activities. • Support release of PKG areas after sanitation.
Planning / Scheduling	• Communicate component and product readiness requirements for PKG sequences. • Maintain visibility of PKG capacity and timing constraints. • Identify risks related to component availability or scheduling conflicts. • Support coordination with Warehouse, Production, and Procurement. • Maintain documentation supporting PKG planning needs.	• Ensure planning decisions align with PKG readiness and component control rules. • Maintain documentation for allocation and timing supporting packaging. • Prevent scheduling actions that bypass PKG controls. • Align changes in plan with PKG readiness requirements. • Maintain traceability for scheduled vs. actual PKG activities.
Procurement Lead	• Provide information on packaging component availability and supplier conditions. • Identify supplier risks impacting PKG operations. • Provide documentation supporting identity and suitability of purchased components. • Support resolution of discrepancies discovered during component receipt. • Coordinate with Warehouse and PKG on component readiness.	• Ensure purchased components align with PKG requirements. • Maintain controlled documentation supporting component verification. • Escalate supplier issues affecting PKG readiness. • Maintain visibility into supply chain conditions impacting PKG. • Support component-control expectations through accurate communication.
Document Control	• Maintain controlled lifecycle of PKG documents and forms. • Ensure only approved templates are used for PKG documentation. • Maintain version control for PKG forms, checklists, and records. • Support retrieval and archival of PKG documentation. • Maintain controlled access to current PKG documents.	• Enforce L0 document-control requirements across PKG documents. • Prevent use of outdated or uncontrolled PKG records. • Maintain metadata and approval integrity for documentation. • Ensure archival meets retention expectations. • Maintain documentation availability for internal and external review.
Training & Competency	• Maintain PKG training requirements across involved roles. • Ensure completion of training prior to performing PKG tasks. • Update training following PKG document changes. • Maintain PKG-related training traceability. • Validate competency for handling PKG-related materials and equipment.	• Enforce training completion per L0 governance. • Maintain ALCOA+ integrity of PKG training records. • Align training with PKG document changes. • Support cross-functional training affecting PKG readiness. • Ensure competency evidence is available for audits.
BRM	• Maintain cross-functional integration of PKG requirements with enterprise workflows. • Identify systemic risks tied to packaging, labeling, or component flow. • Support PKG-related change evaluation across Families. • Maintain visibility of PKG impacts to other process areas. • Support investigations and CAPA related to PKG impacts.	• Apply enterprise-level risk controls to PKG interactions. • Validate alignment of PKG controls across dependent Families. • Maintain documentation supporting integration of PKG within the QMS architecture. • Ensure PKG changes are evaluated for cross-functional impact. • Support escalation pathways for systemic PKG risks.
BPO	• Own operational governance of PKG processes. • Maintain oversight of controls affecting labeling, packaging, and contamination prevention. • Evaluate systemic PKG risks and escalate as appropriate. • Monitor PKG process health and performance. • Ensure PKG alignment with enterprise requirements.	• Ensure PKG processes align with L0 governance requirements. • Maintain consistent application of PKG controls across all areas. • Validate PKG documentation quality supporting compliance. • Maintain oversight of PKG risk mitigation and escalation. • Support enterprise alignment during PKG-related changes.

Quality Unit roles (QA, QC, QA-SOD, QC-SOD) are intentionally excluded from this section.
Their responsibilities are defined globally in the L0 Unified Governance Document and within the QA and QC Family Packs, and therefore apply uniformly across all Process Families.

Section 5 — Required AAs & Traceability Matrix

This section defines the complete and authoritative set of Auditable Artifacts (AAs) required to demonstrate effective control of the Packaging (PKG) domain. Each AA supports a single primary SOP listed in Section 2 and is produced through execution of a corresponding WIN defined in Section 7.

The AA set is intentionally risk-based and consolidated. Each AA has one owning SOP and one primary control intent. Some SOPs are supported by multiple AAs to address distinct verification and reconciliation paths. Individual executions are distinguished by operational metadata (e.g., batch number, date, line ID), not by AA identifier sequencing.

#	SOP	WIN	AA Doc ID	Frequency	Description (Purpose, Scope, Control Intent & Auditor Focus)
Packaging Line Readiness
1	SOP-PKG-SETUP	WIN-PKG-SETUP-01	AA-SOP-PKG-SETUP-LINECLR-CHK-EVT	Per Setup	Purpose: Verify removal of unrelated materials and labels prior to packaging setup. Control Intent: Prevent mix-ups and carryover from prior runs.
2	SOP-PKG-SETUP	WIN-PKG-SETUP-02	AA-SOP-PKG-SETUP-SETUP-REC-BCH	Per Batch	Purpose: Document verified packaging line configuration and readiness. Control Intent: Ensure line setup matches approved configuration prior to execution.
Label Control
3	SOP-PKG-LABEL	WIN-PKG-LABEL-01	AA-SOP-PKG-LABEL-ISSUE-LOG-EVT	Ongoing	Purpose: Maintain accountability of issued, returned, and reconciled labels. Control Intent: Prevent label loss, misuse, or unauthorized issuance.
4	SOP-PKG-LABEL	WIN-PKG-LABEL-02	AA-SOP-PKG-LABEL-VERIFY-CHK-BCH	Per Batch	Purpose: Verify correct label identity, revision, and approval prior to use. Control Intent: Prevent mislabeling and misbranding.
Packaging Execution & Reconciliation
5	SOP-PKG-PACK	WIN-PKG-PACK-01	AA-SOP-PKG-PACK-INPROC-CHK-BCH	Per Run	Purpose: Verify in-process packaging integrity and label correctness during execution. Control Intent: Detect errors before batch completion.
6	SOP-PKG-PACK	WIN-PKG-PACK-02	AA-SOP-PKG-PACK-RECON-FRM-BCH	Per Batch	Purpose: Reconcile used and remaining labels and packaging components. Control Intent: Confirm complete accountability of components.
Post-Run Cleaning
7	SOP-PKG-CLEAN	WIN-PKG-CLEAN-01	AA-SOP-PKG-CLEAN-CLEAN-CHK-EVT	Per Cleaning	Purpose: Verify completion of packaging area and equipment cleaning. Control Intent: Prevent cross-contamination between runs.
8	SOP-PKG-CLEAN	WIN-PKG-CLEAN-01	AA-SOP-PKG-CLEAN-CLEAN-REC-EVT	Per Cleaning	Purpose: Document execution and approval of cleaning activities. Control Intent: Provide auditable evidence of line reset.

Quality Event Escalation (Cross-Domain Governance)

Packaging deviations, label discrepancies, reconciliation failures, contamination risks, or abnormal conditions are escalated using the QA-owned Quality Event process via WIN-QA-EXCEPTION-ESCALATION.

PACKAGING QMS FAMILY PACK

Table of Contents

Section 1 - Family Summary

Section 2 - Purpose, Scope & Regulatory and QC Anchors

Section 3 - General Training Requirements

SOP-PKG-SETUP — Packaging Line Setup

SOP-PKG-LABEL — Label Control & Verification

SOP-PKG-PACK — Packaging Operations

SOP-PKG-CLEAN — Packaging Area Cleaning

Cross-SOP Foundational GMP Expectations

Section 4 - Unified Responsibility & High-Level Control Mapping

Section 5 — Required AAs & Traceability Matrix

Quality Event Escalation (Cross-Domain Governance)

Section 6 — AA Deliverable Requirements

AA-SOP-PKG-SETUP-LINECLR-CHK-EVT — Line Clearance Verification

AA-SOP-PKG-SETUP-SETUP-REC-BCH — Packaging Line Setup

AA-SOP-PKG-LABEL-ISSUE-LOG-EVT — Label Issuance Log

AA-SOP-PKG-LABEL-VERIFY-CHK-BCH — Label Verification

AA-SOP-PKG-PACK-INPROC-CHK-BCH — In-Process Packaging Checks

AA-SOP-PKG-PACK-RECON-FRM-BCH — Packaging Reconciliation

AA-SOP-PKG-CLEAN-CLEAN-CHK-EVT — Cleaning Verification

AA-SOP-PKG-CLEAN-CLEAN-REC-EVT — Cleaning Record

Section 7 — WIN Layer (High-Level Execution & Control Enforcement)

WIN-PKG-SETUP-01 — Line Clearance

WIN-PKG-SETUP-02 — Packaging Line Configuration

WIN-PKG-LABEL-01 — Label Issuance

WIN-PKG-LABEL-02 — Label Verification

WIN-PKG-PACK-01 — Packaging Execution

WIN-PKG-PACK-02 — Component Reconciliation

WIN-PKG-CLEAN-01 — Packaging Area Cleaning

Section 8 - Governance Inheritance