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 PROD responsibilities and WINs must align with these L2 authorities.
The Production (PROD) Process Family governs the controlled preparation, execution, monitoring, clearance, and completion of all manufacturing activities for dietary supplements and regulated product types. Production operations must preserve material identity, prevent contamination, maintain traceability, ensure correct sequencing, and produce each batch in accordance with approved Master Manufacturing Records (MMRs) and specifications.
PROD provides WHAT-level governance for:
Production is foundational because 21 CFR 111 requires manufacturers to:
NSF/ANSI 455-2 reinforces these expectations through requirements for:
Key PROD risk themes include:
PROD requires strong cross-functional interaction with:
Risk Tier Classification: HIGH. Production operations represent the core of GMP compliance. Errors in this Family can directly lead to adulterated product, incorrect formulations, batch inconsistencies, regulatory noncompliance, and potential consumer safety issues. Production therefore carries a HIGH risk classification.
This section defines the WHAT-level purpose, operational scope, regulatory anchors, and Quality Control (QC) requirement anchors for each Production (PROD) SOP within the frozen enterprise SOP hierarchy. Production operates as a QC-Executing domain and directly executes defined in-process quality controls, environmental controls, and deviation response activities under Quality governance.
The SOP list below is authoritative for the PROD Process Family and establishes the scope boundary for Sections 3 through 7 of this Family Pack. No SOPs outside this list may be referenced or implied within PROD governance.
SOPs are ordered according to control dependency and execution lifecycle: personnel and contamination controls first, instruction authority and readiness next, execution and in-process controls during production, followed by batch documentation and post-production reset.
| SOP ID | SOP Title | Purpose (Control Intent) | Scope (Operational Boundary) | QC Requirement Anchors (Executed by PROD) | Regulatory Anchors |
|---|---|---|---|---|---|
| SOP-PROD-HYGIENE | Personnel Hygiene & Illness Control | Establishes requirements to ensure personnel entering or working within production areas do not introduce contamination risks through illness, hygiene failures, or improper conduct. | Applies to all personnel accessing production areas, including hygiene practices, illness reporting, and access restrictions. | QC-ENV-002 (Production environmental conditions) |
21 CFR: 111.10, 111.15, 111.365. NSF/ANSI 455-2: 4.7, 4.8. |
| SOP-PROD-FMCONTROL | Foreign Material Control | Defines controls to prevent introduction of foreign material into product during production activities. | Applies to production areas, equipment, tools, and in-process material handling that may affect foreign material risk. | QC-ENV-002 (Production environmental conditions) |
21 CFR: 111.27, 111.110, 111.365. NSF/ANSI 455-2: 4.6.3, 4.7. |
| SOP-PROD-MMR | Master Manufacturing Record (MMR) Control | Defines requirements for the approval, control, issuance, and correct use of Master Manufacturing Records to ensure consistent and compliant batch execution. | Applies to review, approval, issuance, and controlled use of MMRs during production. Excludes document change control governance. | QC-IPC-002 (In-process acceptance criteria) |
21 CFR: 111.205–111.210. NSF/ANSI 455-2: 4.4.2, 4.6.1. |
| SOP-PROD-PREOP | Pre-Operation Readiness & Line Clearance | Establishes requirements for verifying readiness of equipment, areas, materials, and documentation prior to initiating a production batch. | Applies to pre-start verification activities performed before batch execution. Excludes sanitation and maintenance execution activities. | QC-ENV-002 (Production environmental conditions) QC-IPC-002 (In-process acceptance criteria) |
21 CFR: 111.25, 111.255. NSF/ANSI 455-2: 4.6.1, 4.6.3. |
| SOP-PROD-BLEND (IPC) | Blending Execution with In-Process Controls | Defines requirements for controlled execution of blending operations and performance of defined in-process controls to ensure uniformity and traceability. | Applies to preparation, execution, monitoring, and documentation of all blending operations performed per an approved MMR. | QC-IPC-002 (In-process acceptance criteria) QC-IPC-004 (In-process deviation response) |
21 CFR: 111.70, 111.255–111.260. NSF/ANSI 455-2: 4.6.1, 4.6.4. |
| SOP-PROD-FILL (IPC) | Filling Operations with In-Process Controls | Establishes requirements for controlled filling operations and execution of in-process controls for powders, liquids, and capsules. | Applies to filling setup, execution, monitoring, and documentation. Excludes blending and packaging operations. | QC-IPC-002 (In-process acceptance criteria) QC-IPC-004 (In-process deviation response) |
21 CFR: 111.70, 111.255–111.260. NSF/ANSI 455-2: 4.6.1, 4.6.4. |
| SOP-PROD-BPR | Batch Production Record (BPR) | Defines requirements for execution, compilation, and completion of the Batch Production Record as the authoritative GMP evidence of batch execution. | Applies to compilation, review readiness, and completion of all production records associated with a batch. | QC-IPC-004 (In-process deviation response) |
21 CFR: 111.255–111.260, 111.123. NSF/ANSI 455-2: 4.4.2, 4.10. |
| SOP-PROD-CLEAN | Post-Production Cleaning Verification | Establishes requirements to verify that production equipment and areas have been appropriately cleaned and are suitable for subsequent use. | Applies to post-production cleaning verification and documentation. Excludes sanitation program governance and cleaning method execution. | QC-ENV-002 (Production environmental conditions) |
21 CFR: 111.27, 111.35, 111.365. NSF/ANSI 455-2: 4.7, 4.6.3. |
Production (PROD) 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 Production 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.
The following WHAT-level training requirements apply to all personnel who prepare, execute, support, monitor, or document Production (PROD) activities. These requirements ensure personnel understand the quality, safety, identity, traceability, and contamination-prevention expectations governing manufacturing operations.
Training requirements in this section are grouped by governing SOP to clearly communicate control ownership and competency expectations. These requirements do not describe HOW tasks are performed and do not replace Work Instructions (WINs).
This section defines WHAT-level responsibilities and high-level controls for all L0-approved roles that perform, supervise, support, review, or influence Production (PROD) activities. This section does not describe HOW tasks are performed and contains no references to SOPs, WINs, or FORMs.
| Role | Primary Responsibilities (WHAT) | High-Level Controls (WHAT Requirements) |
|---|---|---|
| Production Operator |
• Perform manufacturing activities in alignment with approved production instructions. • Maintain identity and segregation of all materials used in production. • Identify abnormal equipment or material conditions requiring escalation. • Document all required production information accurately and contemporaneously. • Maintain cleanliness and organization within the production workspace. |
• Follow identity, status, and traceability controls for all in-process materials. • Ensure production documentation meets ALCOA+ expectations. • Maintain boundaries preventing contamination or mix-ups. • Apply controlled checks before using materials or tools. • Ensure all work occurs within approved production areas. |
| Production Supervisor |
• Oversee production activities to ensure compliance with approved manufacturing requirements. • Ensure personnel follow material identity, segregation, and traceability expectations. • Escalate abnormal conditions or discrepancies affecting production readiness. • Maintain oversight of production documentation and completeness. • Coordinate readiness activities with Warehouse, QA, QC, and Maintenance. |
• Validate that production areas and materials meet required conditions before use. • Maintain oversight of in-process control expectations. • Ensure production records reflect complete and accurate information. • Apply risk-based oversight of deviations affecting production. • Maintain controlled flow of materials and information through the process. |
| Warehouse Operator |
• Deliver materials to production in accordance with status and identity controls. • Maintain segregation of materials during staging and returns. • Identify discrepancies in labeling or documentation prior to release to production. • Support accurate recording of material issuance and return. • Maintain clean and compliant staging locations. |
• Follow identity and segregation controls when issuing materials. • Maintain traceability of all material movements supporting production. • Prevent unauthorized movement of non-approved materials. • Ensure staging locations align with required environmental and cleanliness expectations. • Maintain compliant documentation for issuance and return. |
| Warehouse Supervisor |
• Oversee staging, issuance, and return of materials supporting production activities. • Ensure operators follow status and segregation expectations during material flow. • Monitor staging accuracy and escalate discrepancies. • Coordinate material readiness in alignment with production schedules. • Maintain oversight of material records that support batch integrity. |
• Validate that all staged materials meet identity, status, and documentation expectations. • Maintain controls preventing mix-ups or incorrect deliveries. • Ensure compliance with traceability and allocation requirements. • Maintain complete and accurate issuance documentation. • Support risk-based escalation for material-related discrepancies. |
| Maintenance Technician |
• Maintain equipment used in production to ensure proper function. • Identify issues that could affect equipment suitability or safety. • Support remediation of equipment-related production risks. • Prevent maintenance activities from introducing contamination. • Escalate maintenance conditions affecting production readiness. |
• Ensure equipment is maintained in a state suitable for production use. • Maintain documentation of work impacting production equipment. • Apply controls preventing contamination during maintenance. • Support environmental and safety expectations for production equipment. • Follow defined boundaries for access to production areas. |
| Facilities / Utilities Technician |
• Maintain facility conditions that support production readiness. • Identify environmental or structural risks affecting production operations. • Maintain airflow, temperature, and environmental controls for production spaces. • Support remediation of facility conditions affecting product integrity. • Escalate deficiencies impacting production suitability. |
• Maintain environmental conditions within acceptable limits. • Ensure utilities function in ways that support compliant production. • Maintain documentation supporting facility readiness. • Prevent facility work from introducing contamination. • Ensure facility issues are resolved to protect product quality. |
| Sanitation Technician |
• Maintain cleanliness of production areas to prevent contamination or mix-ups. • Identify sanitation conditions affecting production readiness. • Support removal of debris or residues that may impact material integrity. • Maintain sanitation records relevant to production areas. • Escalate environmental or cleanliness issues requiring attention. |
• Apply contamination-prevention expectations during sanitation activities. • Maintain controlled sanitation documentation supporting production readiness. • Follow boundaries for performing sanitation in active production zones. • Ensure sanitation activities protect equipment and materials. • Support release of production areas following sanitation. |
| Planning / Scheduling |
• Maintain visibility of production needs and material availability. • Communicate timing and sequencing requirements that influence production readiness. • Identify risks related to production delays or shortages. • Support coordination across Warehouse, Production, and Procurement. • Maintain scheduling documentation supporting production flow. |
• Ensure planning decisions align with production capacity and readiness controls. • Support documentation for allocation and timing of materials. • Maintain alignment between plan changes and production readiness. • Prevent scheduling actions that bypass status or material controls. • Maintain traceability for planned vs. actual production activity. |
| Procurement Lead |
• Maintain communication regarding material availability and supplier-related risks. • Provide Warehouse and Production with information about incoming materials. • Identify supplier issues impacting production scheduling. • Maintain documentation supporting material readiness for production. • Support resolution of material discrepancies discovered during production. |
• Ensure purchased materials align with production requirements. • Maintain controlled documentation supporting receiving and staging. • Escalate supplier risks that may affect production. • Maintain visibility over supply chain conditions affecting readiness. • Support cross-functional alignment for material availability. |
| Document Control |
• Maintain controlled lifecycle of production documents and forms. • Ensure only approved templates are used for production documentation. • Maintain version control for production forms and batch records. • Support retrieval and archival of production records. • Provide access to current documents across functional areas. |
• Enforce document-control rules for production documents. • Prevent use of outdated production forms. • Maintain metadata and version integrity for controlled documents. • Ensure archival meets retention and retrieval requirements. • Maintain availability of controlled documents for audits. |
| Training & Competency |
• Maintain training requirements for personnel performing production activities. • Ensure personnel are trained before performing production tasks. • Update training following production document changes. • Maintain training traceability supporting production compliance. • Validate competency for personnel performing production operations. |
• Enforce training completion prior to task execution. • Maintain ALCOA+ integrity of production training records. • Support cross-functional training requirements impacting production. • Align training with controlled production documents. • Ensure competency evidence is audit-ready. |
| BRM |
• Maintain cross-functional alignment of production with enterprise workflows. • Identify systemic risks relating to production activities. • Support changes affecting Production, Warehouse, QA, QC, and Planning. • Maintain transparency of production impacts across Families. • Support investigations and CAPA impacting production. |
• Apply enterprise-wide risk controls to production interactions. • Validate alignment of production controls across dependent Families. • Ensure production-related changes maintain QMS consistency. • Maintain documentation supporting cross-family integration. • Ensure cross-functional impacts are managed and communicated. |
| BPO |
• Own operational governance of production requirements. • Maintain oversight of controls affecting identity, traceability, and contamination prevention. • Evaluate systemic risks associated with production operations. • Maintain process health monitoring for production workflows. • Ensure production processes align with enterprise requirements. |
• Ensure production processes comply with L0 governance and QMS architecture. • Maintain consistent application of production controls across the organization. • Validate documentation quality supporting production activities. • Maintain oversight of production-related risks and escalation pathways. • Support enterprise alignment during production-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.
This section defines the complete and authoritative set of Auditable Artifacts (AAs) required to demonstrate effective control of the Production (PROD) 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 documentation paths. Individual executions are distinguished by operational metadata (e.g., batch number, date, equipment ID), not by AA identifier sequencing.
| # | SOP | WIN | AA Doc ID | Frequency | Description (Purpose, Scope, Control Intent & Auditor Focus) |
|---|---|---|---|---|---|
| Personnel & Contamination Controls | |||||
| 1 | SOP-PROD-HYGIENE | WIN-PROD-HYGIENE | AA-PROD-HYGIENE-CHK | Per Entry / Shift |
Purpose: Verify personnel hygiene and illness controls
prior to production access. Control Intent: Prevent contamination from personnel sources. |
| 2 | SOP-PROD-FMCONTROL | WIN-PROD-FMCONTROL | AA-PROD-FMCONTROL-CHK | Routine / Event-Driven |
Purpose: Verify foreign material prevention controls
in production areas. Control Intent: Prevent introduction of extraneous material into product. |
| Pre-Operation Readiness | |||||
| 3 | SOP-PROD-PREOP | WIN-PROD-PREOP | AA-PROD-PREOP-CHK | Per Batch |
Purpose: Verify equipment, area, and documentation
readiness prior to batch execution. Control Intent: Prevent initiation of production without readiness verification. |
| 4 | SOP-PROD-MMR | WIN-PROD-MMR | AA-PROD-MMR-REC | Per Batch |
Purpose: Document issuance and use of the approved
Master Manufacturing Record. Control Intent: Ensure execution aligns with approved instructions. |
| Production Execution & IPC | |||||
| 5 | SOP-PROD-BLEND (IPC) | WIN-PROD-BLEND | AA-PROD-BLEND-REC | Per Batch |
Purpose: Document blending execution and defined
in-process controls. Control Intent: Ensure blend uniformity and execution traceability. |
| 6 | SOP-PROD-FILL (IPC) | WIN-PROD-FILL | AA-PROD-FILL-LOG | Per Run |
Purpose: Provide chronological record of filling
operations and IPC monitoring. Control Intent: Maintain continuous control during filling. |
| Batch Documentation & Reset | |||||
| 7 | SOP-PROD-BPR | WIN-PROD-BPR | AA-PROD-BPR-REC | Per Batch |
Purpose: Compile authoritative GMP evidence for batch
execution. Control Intent: Enable Quality review and disposition. |
| 8 | SOP-PROD-CLEAN | WIN-PROD-CLEAN | AA-PROD-CLEAN-CHK | Per Cleaning |
Purpose: Verify post-production cleaning completion. Control Intent: Prevent cross-contamination between batches. |
Deviations, IPC failures, contamination risks, or abnormal conditions identified during Production execution are escalated through the QA-owned Quality Event process using WIN-QA-EXCEPTION-ESCALATION.
This section defines the minimum required content and evidentiary intent for each Auditable Artifact (AA) listed in Section 5. These requirements establish WHAT must be captured to demonstrate effective control of Production (PROD) activities.
The AA set is intentionally risk-based, consolidated, and sufficient. Each AA represents the authoritative GMP evidence for its associated production control domain. No additional PROD-specific records are required beyond those defined in Section 5.
Individual executions are distinguished through operational metadata (e.g., batch number, date, time, equipment ID, operator credentials), not through creation of additional forms or variants.
This section defines the WHEN, WHO, and CONTROL OUTCOME expectations for execution of Production (PROD) controls. Work Instructions (WINs) enforce SOP requirements and generate the Auditable Artifacts (AAs) defined in Section 5. Procedural HOW is intentionally excluded.
This Family Pack inherits all enterprise-level governance defined in the L0 Unified Governance Document (L0-QMS-UGD), which serves as the authoritative source for quality, documentation, data integrity, and system requirements. All SOPs, WINs, and FORMs within this Family must be created, maintained, and executed in alignment with L0 rules, including:
L0 requirements apply uniformly and supersede all Family-level content. This Family Pack does not replace or modify L0 governance and operates fully within the enterprise-wide QMS architecture.