This section defines how federal regulations, industry standards, customer requirements, and internal quality expectations are referenced within the QMS. Level-0 documents contain authoritative regulatory citations; lower-level documents reference L0 rather than citing regulations directly, ensuring single-source citation control.
SNL governs its Quality Management System through a disciplined, three-tier regulatory-citation model that ensures requirements are applied consistently, executed correctly, and proven through auditable evidence. At the foundation, the 21 CFR 111 Master Regulatory Cross-Reference Table centralizes every applicable federal requirement in one location, eliminating interpretation drift and preventing redundant or conflicting citations across SOPs, WINs, and FORMs. Complementing this, the NSF/ANSI 455-2 crosswalk integrates certification and audit requirements directly into the same structure, enabling SNL to operate a single, harmonized system rather than maintaining parallel compliance programs.
Finally, SNL’s structured Risk-Tiering Model (High, Medium, Low Risk) ensures that regulatory controls are applied proportionally to process risk, focusing the highest governance on activities that directly impact product safety, identity, purity, strength, and quality. Together, these three mechanisms create a QMS that is traceable, audit-ready, and deeply aligned with regulatory expectations — ensuring SNL meets all requirements with clarity, consistency, and defensible evidence.
Family Packs MAY restate applicable regulatory citations for clarity and traceability, provided that all citations are sourced directly and verbatim from L0. L0 remains the authoritative master reference; Family Packs do not create or modify regulatory requirements, and may only restate citations to support scoping, audit alignment, and process-family transparency.
This table maps every applicable requirement in 21 CFR 111 to the controlling SOP (WHAT) and the expected Auditable Evidence (AA) that demonstrates compliance.
Format:
Citations:
| ID | 21 CFR Citation | Requirement Summary | Primary SOPs | Evidence (AA) |
|---|---|---|---|---|
| R-111.8 | 111.8 — Illness & Disease Control | Personnel with illness, infections, or open lesions must be excluded from operations where contamination is possible. | SOP-PROD-HYGIENE SOP-SAN-EMP |
Illness reporting logs Personnel exclusion records |
| R-111.10 | 111.10 — Personnel Hygiene Practices | Requires proper hygiene practices including handwashing, protective clothing, cleanliness, and prevention of contamination. | SOP-PROD-HYGIENE SOP-SAN-EMP |
Hygiene training records Hygiene inspection logs |
| R-111.12 | 111.12 — Personnel Qualifications | Personnel must have the education, training, or experience to perform assigned duties related to CGMP activities. | SOP-TAL-TRAIN SOP-TAL-COMP SOP-TAL-QUAL SOP-QA-IA SOP-QA-MGMTREV |
Training records Qualification files Competency assessments |
| R-111.14 | 111.14 — Supervisor Responsibilities | Supervisors must ensure compliance with CGMPs and verify personnel perform operations correctly and safely. | SOP-TAL-QUAL SOP-QA-IA SOP-QA-MGMTREV |
Supervisor verifications Training oversight logs |
| ID | 21 CFR Citation | Requirement Summary | Primary SOPs | Evidence (AA) |
|---|---|---|---|---|
| R-111.8 | 111.8 — Illness & Disease Control | Personnel with illness, infections, or open lesions must be excluded from operations where contamination is possible. | SOP-PROD-HYGIENE SOP-SAN-EMP |
Illness reporting logs Personnel exclusion records |
| R-111.10 | 111.10 — Personnel Hygiene Practices | Requires proper hygiene practices including handwashing, protective clothing, cleanliness, and prevention of contamination. | SOP-PROD-HYGIENE SOP-SAN-EMP |
Hygiene training records Hygiene inspection logs |
| R-111.12 | 111.12 — Personnel Qualifications | Personnel must have the education, training, or experience to perform assigned duties related to CGMP activities. | SOP-TAL-TRAIN SOP-TAL-COMP SOP-TAL-QUAL SOP-QA-IA SOP-QA-MGMTREV |
Training records Qualification files Competency assessments |
| R-111.14 | 111.14 — Supervisor Responsibilities | Supervisors must ensure compliance with CGMPs and verify personnel perform operations correctly and safely. | SOP-TAL-QUAL SOP-QA-IA SOP-QA-MGMTREV |
Supervisor verifications Training oversight logs |
| ID | 21 CFR Citation | Requirement Summary | Primary SOPs | Evidence (AA) |
|---|---|---|---|---|
| R-111.15 | 111.15 — Sanitary Operations | Facility must be maintained in a clean, sanitary condition to prevent contamination of components, in-process materials, and finished products. | SOP-SAN-CLEAN SOP-SAN-MASTER SOP-MAINT-FACILITY |
Sanitation logs Environmental cleaning records Facility inspection reports |
| R-111.20 | 111.20 — Facility Design & Construction | Facilities must be designed and constructed to ensure sanitary operations, efficient cleaning, and prevention of contamination or mixups. | SOP-MAINT-FACILITY SOP-SAN-MASTER |
Facility maps Environmental control logs Design review documents |
| R-111.27(a) | 111.27(a) — Cleaning of Contact Surfaces | All food-contact surfaces must be cleaned and sanitized as necessary to prevent contamination and cross-contact. | SOP-PROD-CLEAN SOP-SAN-CLEAN SOP-PKG-CLEAN |
Cleaning logs ATP results Sanitation verification records |
| R-111.27(b) | 111.27(b) — Cleaning Frequency | Cleaning must occur at appropriate frequencies to maintain sanitary conditions and prevent buildup of contaminants. | SOP-SAN-MASTER SOP-PROD-CLEAN SOP-PKG-CLEAN |
Master sanitation schedule Cleaning frequency records |
| R-111.27(d) | 111.27(d) — Equipment Inspection Before Use | Equipment and utensils must be inspected immediately before use to ensure cleanliness and proper function. | SOP-PROD-PREOP SOP-PKG-SETUP |
Pre-op inspection checklists Line clearance records |
| R-111.30 | 111.30 — Equipment & Utensil Handling | Equipment and utensils must be designed, constructed, and maintained to avoid contamination and allow proper cleaning and sanitizing. | SOP-PROD-PREOP SOP-WH-STOR SOP-WH-INVT SOP-MH-HANDLING |
Equipment inspection logs Material handling records |
| ID | 21 CFR Citation | Requirement Summary | Primary SOPs | Evidence (AA) |
|---|---|---|---|---|
| R-111.35(a) | 111.35(a) — Equipment Design & Construction | Equipment must be of appropriate design, construction, and workmanship to avoid contamination and allow proper cleaning and maintenance. | SOP-MAINT-FACILITY SOP-MAINT-PM SOP-PROD-PREOP |
Equipment design specs Maintenance records |
| R-111.35(b)(1) | 111.35(b)(1) — Routine Maintenance | Equipment must be maintained to ensure proper function and prevent contamination or mixups. | SOP-MAINT-PM SOP-MAINT-FACILITY |
PM schedules Maintenance logs |
| R-111.35(b)(2) | 111.35(b)(2) — Calibration Requirements | Instruments and controls must be calibrated routinely against certified standards to ensure accuracy. | SOP-MAINT-CAL SOP-MAINT-CAL-PROGRAM |
Calibration certificates Calibration logs |
| R-111.35(b)(3) | 111.35(b)(3) — Calibration Documentation | Calibration activities must be documented, including date, method, standard used, and results. | SOP-MAINT-CAL SOP-MAINT-CAL-PROGRAM |
Calibration reports Instrument verification logs |
| R-111.35(b)(4) | 111.35(b)(4) — Out-of-Tolerance Controls | If equipment is found out of calibration, appropriate actions must be taken, including evaluating impact on product quality. | SOP-MAINT-CAL SOP-MAINT-CAL-PROGRAM SOP-QA-DEV SOP-QA-CAPA |
OOS/OOT investigations Deviation/CAPA records |
| R-111.35(b)(5) | 111.35(b)(5) — Electronic Records & Backups | Electronic systems used for equipment control or recordkeeping must ensure integrity, prevent loss, and provide secure backups. | SOP-IT-ACCESS SOP-IT-BACKUP SOP-IT-ESIG SOP-IT-VALIDATE |
Backup logs Access control logs System validation documentation |
| R-111.35(c) | 111.35(c) — Automatic, Mechanical & Electronic Equipment | Automatic, mechanical, or electronic equipment must be routinely checked to ensure proper function, including alarms and monitoring systems. | SOP-MAINT-PM SOP-PROD-PREOP SOP-PKG-SETUP |
Pre-op functional checks Maintenance logs |
| R-111.35(d) | 111.35(d) — Cleaning of Equipment | Equipment must be cleaned and sanitized as necessary to prevent contamination, cross-contact, or adulteration. | SOP-PROD-CLEAN SOP-SAN-CLEAN SOP-PKG-CLEAN SOP-SAN-MASTER |
Cleaning logs Sanitation verification records |
| R-111.70 | 111.70 — Specifications & Controls | Specifications must be established for equipment function, calibration, and process control to ensure proper operation. | SOP-MAINT-PM SOP-MAINT-CAL SOP-PROD-PREOP |
Specification sheets Calibration records Pre-op verification |
| ID | 21 CFR Citation | Requirement Summary | Primary SOPs | Evidence (AA) |
|---|---|---|---|---|
| R-111.70(a) | 111.70(a) — Component Specifications | Establish specifications for identity, purity, strength, composition, and limits on contaminants for each component used. | SOP-QA-SPEC-PROGRAM SOP-QCP-SAMPLE SOP-QCL-TEST SOP-PROC-DOCS |
Specification sheets COA review records Component test reports |
| R-111.70(b) | 111.70(b) — In-Process Specifications | Establish in-process specifications to ensure proper control of production stages (weighing, blending, encapsulation, filling). | SOP-PROD-PREOP SOP-PROD-WEIGH SOP-PROD-BLEND SOP-PROD-ENCAP SOP-PKG-PACK SOP-QCP-IPC |
In-process check logs Batch records IPC test sheets |
| R-111.70(c) | 111.70(c) — Finished Product Specifications | Establish specs for identity, purity, strength, composition, and contaminant limits for each finished dietary supplement. | SOP-QA-SPEC-PROGRAM SOP-QCL-TEST SOP-QA-REL |
Specification documents Final test results Release packets |
| R-111.70(d) | 111.70(d) — Packaging & Labeling Specifications | Establish specifications to ensure correct packaging components and labels are used, including fill count, closure integrity, and label accuracy. | SOP-PKG-LABEL SOP-PKG-PACK SOP-PKG-SETUP SOP-QCP-IPC |
Packaging specs Label approval files Reconciliation logs |
| R-111.70(e) | 111.70(e) — Labeling Operations Controls | Labeling must be controlled to ensure correct labels are applied, proper batch coding, and no mixups occur. | SOP-PKG-LABEL SOP-PKG-PACK SOP-PKG-SETUP |
Label verification logs Batch coding checklists |
| R-111.73 | 111.73 — Specifications Must Be Met | All established specifications must be met before materials or products can be approved and released. | SOP-QA-REL SOP-QA-SPEC-PROGRAM SOP-QCL-TEST |
QC release documentation Test reports |
| R-111.75(a) | 111.75(a) — Component Identity Testing | Each component must be tested for identity before use in manufacturing. | SOP-QCP-SAMPLE SOP-QCL-TEST SOP-WH-RECV |
Identity test results COA comparison logs |
| R-111.75(c) | 111.75(c) — In-Process Testing | In-process materials must be tested as necessary to ensure specifications are met during production stages. | SOP-PROD-WEIGH SOP-PROD-BLEND SOP-PROD-ENCAP SOP-QCP-IPC |
IPC logs Batch records |
| R-111.75(h) | 111.75(h) — Specifications Not Met / Deviations | Any failure to meet specifications requires documented investigation and appropriate corrective actions. | SOP-QA-DEV SOP-QA-CAPA SOP-QCL-DATA |
Deviation reports CAPA records OOS/OOT logs |
| R-111.80 | 111.80 — Component Control & Sampling | Components must be handled under procedures that prevent mixups, contamination, and ensure proper sampling. | SOP-QA-SAMPLING-PROGRAM SOP-QCP-SAMPLE SOP-WH-RECV SOP-WH-STOR |
Sampling logs Reserve sample files |
| R-111.95 | 111.95 — QC Review of Material Control Systems | QC must review and approve all specifications and processes for component control, in-process control, and finished product release. | SOP-QA-REL SOP-QA-SPEC-PROGRAM SOP-QA-DEV |
QC approval records Release documentation |
| R-111.117 | 111.117 — Documentation of Production & Process Control System | All production and process control systems must be adequately documented to ensure repeatability, traceability, and compliance. | SOP-PROD-BATCH SOP-QA-DC SOP-QA-REL |
Batch production records Document control logs |
| ID | 21 CFR Citation | Requirement Summary | Primary SOPs | Evidence (AA) |
|---|---|---|---|---|
| R-111.120 | 111.120 — QC Approval & Rejection Authority | QC must approve or reject all components, in-process materials, finished products, packaging, labeling, and operations based on whether specifications are met. | SOP-QA-REL SOP-QA-SPEC-PROGRAM SOP-QCL-TEST SOP-QA-NCMR |
QC release approvals QC rejection records |
| R-111.123(a) | 111.123(a) — QC Review & Release Decisions | QC must review all required information before releasing or rejecting any component, product, or operation. | SOP-QA-REL SOP-QA-DEV SOP-QA-CAPA |
Release packets QC approval signatures |
| R-111.123(b) | 111.123(b) — Batch Record Review | QC must review every batch production record to ensure accuracy, completeness, and compliance with the MMR before final product release. | SOP-PROD-BATCH SOP-QA-REL SOP-QA-DC |
Batch record review checklists QC release records |
| R-111.123(c) | 111.123(c) — Laboratory Records Review | QC must review and approve all laboratory test results—including in-process, component, and finished product data—before release. | SOP-QCL-TEST SOP-QCL-DATA SOP-QA-REL |
Lab data packets QC-reviewed test results |
| R-111.123(d) | 111.123(d) — QC Review of Packaging & Labeling Records | QC must review packaging and labeling operations, including reconciliation, label verification, and line clearance records. | SOP-PKG-LABEL SOP-PKG-PACK SOP-PKG-SETUP SOP-QA-REL |
Label reconciliation logs Packaging batch records |
| R-111.123(e) | 111.123(e) — QC Review of Deviations & OOS | QC must review investigations of deviations, OOS/OOT results, and nonconformances and must approve final conclusions. | SOP-QA-DEV SOP-QA-CAPA SOP-QCL-DATA SOP-QA-NCMR |
Deviation reports OOS investigations CAPA records |
| R-111.127 | 111.127 — QC Oversight of Corrective Actions | QC must ensure corrective actions are implemented when necessary and must verify effectiveness of implemented CAPAs. | SOP-QA-CAPA SOP-QA-DEV SOP-QA-IA |
CAPA verification records Audit reports |
| R-111.130 | 111.130 — QC Personnel Responsibilities | QC personnel must be qualified and must oversee all quality-related activities, including review, approval, and documentation control. | SOP-TAL-QUAL SOP-TAL-TRAIN SOP-QA-DC SOP-QA-REL |
Training files QC competency assessments |
| R-111.135 | 111.135 — QC Approval of MMRs | QC must review and approve all Master Manufacturing Records (MMRs) to ensure they contain the required information and controls. | SOP-PROD-MMR SOP-QA-REL SOP-QA-DC |
Approved MMRs MMR change control records |
| R-111.140 | 111.140 — QC Final Disposition Decisions | QC must make final disposition decisions for batches, including approval, rejection, or required reprocessing actions. | SOP-QA-REL SOP-QA-NCMR SOP-QA-RETURNS |
Final QC disposition records Release/rejection documentation |
| ID | 21 CFR Citation | Requirement Summary | Primary SOPs | Evidence (AA) |
|---|---|---|---|---|
| R-111.145(a) | 111.145(a) — Control of Components, In-Process & Finished Materials | Materials must be held under conditions that prevent contamination, mixups, and deterioration. Includes components, in-process materials, and finished supplements. | SOP-WH-STOR SOP-WH-INVT SOP-MH-HANDLING SOP-MH-SEG |
Storage logs Temperature/humidity checks Segregation maps |
| R-111.145(b) | 111.145(b) — Environmental Control of Storage Areas | Storage areas must have appropriate environmental controls as required by product specifications (e.g., temperature, humidity, cleanliness). | SOP-WH-STOR SOP-MAINT-FACILITY |
Environmental logs Facility inspection records |
| R-111.145(c) | 111.145(c) — Prevention of Mixups During Holding | Areas and containers must be labeled and organized to prevent mixups of materials during storage and handling operations. | SOP-WH-STOR SOP-WH-INVT SOP-MH-SEG |
Status labels Storage location logs |
| R-111.150(a) | 111.150(a) — Quarantine Procedures | Components, in-process materials, and finished products must be quarantined until QC releases them. | SOP-WH-STOR SOP-WH-INVT SOP-QA-REL |
Quarantine logs Status control documentation |
| R-111.150(b) | 111.150(b) — Status Identification | All materials must be clearly identified with status (e.g., quarantined, approved, rejected) to prevent unauthorized use. | SOP-WH-STOR SOP-WH-INVT SOP-WH-RACKMAP SOP-QA-REL |
Status tags WIP tracking logs |
| R-111.153 | 111.153 — Requirements for Handling Components | Components must be handled to prevent contamination, deterioration, and mixups during receiving, staging, and transfer activities. | SOP-WH-RECV SOP-MH-HANDLING SOP-MH-SEG |
Receiving logs Material movement logs |
| R-111.155 | 111.155 — Handling of Rejected Materials | Rejected components or products must be clearly identified, segregated, and controlled to prevent accidental use. | SOP-QA-NCMR SOP-QA-REL SOP-WH-STOR |
Rejection tags Disposition records |
| R-111.160 | 111.160 — Release for Distribution | Finished products must not be distributed until QC approves release and all specifications are met. | SOP-QA-REL SOP-WH-SHIP SOP-WH-INVT |
Release documentation Shipping logs |
| ID | 21 CFR Citation | Requirement Summary | Primary SOPs | Evidence (AA) |
|---|---|---|---|---|
| R-111.205 | 111.205 — MMR Requirements | Each unique formulation and batch size must have an MMR containing instructions and controls necessary to ensure uniformity and consistency in production. | SOP-PROD-MMR SOP-QA-DC SOP-QA-REL |
Approved MMR MMR revision history |
| R-111.210(a) | 111.210(a) — Required MMR Components | The MMR must include required elements such as product name, strength, batch size, complete list of components, and their specifications. | SOP-PROD-MMR SOP-QA-DC |
MMR content checklist Document control approval |
| R-111.210(b) | 111.210(b) — Theoretical Yield Requirements | MMRs must include theoretical yield, including acceptable yield ranges to detect deviations in actual production. | SOP-PROD-MMR SOP-PROD-BATCH |
Yield calculation sheets MMR-approved tolerances |
| R-111.210(c) | 111.210(c) — Manufacturing Instructions | MMRs must include step-by-step manufacturing instructions such as weighing, blending, encapsulation/packaging, and process controls. | SOP-PROD-MMR SOP-PROD-WEIGH SOP-PROD-BLEND SOP-PROD-ENCAP SOP-PKG-PACK |
Approved MMR instructions Revision-controlled documents |
| R-111.210(d) | 111.210(d) — Equipment Requirements | MMRs must identify equipment and utensils needed for production and specify controls for their use. | SOP-PROD-MMR SOP-PROD-PREOP SOP-MAINT-FACILITY |
Equipment list in MMR Pre-op checklists |
| R-111.210(e) | 111.210(e) — Component Specifications in MMR | MMRs must include the specifications for each component (identity, purity, strength, composition). | SOP-PROD-MMR SOP-QA-SPEC-PROGRAM SOP-QCL-TEST |
Specification sheets Component test results |
| R-111.210(f) | 111.210(f) — Packaging & Labeling Instructions | MMRs must define packaging and labeling instructions, including label control, batch coding, and reconciliation requirements. | SOP-PROD-MMR SOP-PKG-LABEL SOP-PKG-PACK SOP-QA-REL |
Label approval files Packaging instructions |
| R-111.210(g) | 111.210(g) — MMR Verification & Approval | MMRs must be reviewed, verified, and approved by QC prior to use to ensure completeness and correctness. | SOP-PROD-MMR SOP-QA-REL SOP-QA-DC |
MMR approval records Change-control documentation |
| ID | 21 CFR Citation | Requirement Summary | Primary SOPs | Evidence (AA) |
|---|---|---|---|---|
| R-111.255 | 111.255 — BPR Requirements | A BPR must be prepared for each batch and must accurately follow the corresponding MMR, documenting each significant step in production. | SOP-PROD-BATCH SOP-PROD-WEIGH SOP-PROD-BLEND SOP-PROD-ENCAP SOP-PKG-PACK SOP-QA-REL SOP-QA-DC |
Executed BPR Operator signatures QC review signatures |
| R-111.260(a) | 111.260(a) — Equipment & Utensil Identification | BPR must identify major equipment and utensils used in batch production to ensure traceability and validation of cleanliness. | SOP-PROD-BATCH SOP-PROD-PREOP SOP-PROD-CLEAN |
Equipment logs Pre-op checklists |
| R-111.260(b) | 111.260(b) — Component Identification & Weighing | BPR must document the identity and quantity of each component weighed, including lot numbers and verification requirements. | SOP-PROD-WEIGH SOP-PROD-BATCH SOP-MH-HANDLING |
Weigh tickets Lot traceability logs |
| R-111.260(c) | 111.260(c) — Yield & Yield Verification | BPR must document theoretical vs actual yield and verify that yield is within predetermined acceptable limits. | SOP-PROD-BATCH SOP-PROD-MMR SOP-QA-REL |
Yield records Batch reconciliation sheets |
| R-111.260(d) | 111.260(d) — In-Process Controls Documentation | BPR must document each in-process control (blend uniformity, capsule fill weight, metal detection, count accuracy) and results. | SOP-QCP-IPC SOP-PROD-ENCAP SOP-PROD-BLEND SOP-PKG-PACK |
IPC logs Equipment setup verification |
| R-111.260(e) | 111.260(e) — Line Clearance Documentation | BPR must document line clearance activities prior to manufacturing or packaging to prevent cross-contamination or mixups. | SOP-PROD-PREOP SOP-PKG-SETUP SOP-PROD-BATCH |
Line clearance forms Pre-op checklists |
| R-111.260(f) | 111.260(f) — Documentation of Each Manufacturing Step | Each major step must be documented at time of performance with operator signatures, dates, times, and verification when required. | SOP-PROD-BATCH SOP-PROD-WEIGH SOP-PROD-BLEND SOP-PROD-ENCAP SOP-PKG-PACK |
Timestamped BPR entries Operator & verifier signatures |
| R-111.260(g) | 111.260(g) — Packaging & Labeling Documentation | BPR must include records of packaging operations including fill count checks, label verification, and reconciliation activities. | SOP-PKG-PACK SOP-PKG-LABEL SOP-QCP-IPC SOP-QA-REL |
Packaging batch records Label reconciliation logs |
| R-111.260(h) | 111.260(h) — Documentation of Cleaning Activities | BPR must document cleaning of equipment, utensils, and production areas when performed during the batch. | SOP-PROD-CLEAN SOP-SAN-CLEAN SOP-PKG-CLEAN SOP-PROD-BATCH |
Cleaning logs Sanitation verification records |
| R-111.260(i) | 111.260(i) — QC Review & Approval of BPR | BPR must be reviewed and approved by QC to ensure accuracy, completeness, and compliance prior to product release. | SOP-QA-REL SOP-QA-DC SOP-PROD-BATCH |
QC-reviewed BPR Final disposition records |
| ID | 21 CFR Citation | Requirement Summary | Primary SOPs | Evidence (AA) |
|---|---|---|---|---|
| R-111.303 | 111.303 — Laboratory Control System | A laboratory control system must be established and implemented to ensure testing, approval, and documentation of specifications for components, in-process materials, and finished products. | SOP-QCL-TEST SOP-QCL-DATA SOP-QA-SPEC-PROGRAM SOP-QA-REL |
Lab control logs Test method files Specification approvals |
| R-111.310 | 111.310 — Scientifically Valid Test Methods | Testing must be performed using scientifically valid methods, including identity testing (e.g., FTIR), strength, purity, and composition testing. | SOP-QCL-TEST SOP-QCL-DATA SOP-QA-SPEC-PROGRAM |
Validated method sheets Vendor method files Test reports |
| R-111.315 | 111.315 — Laboratory Operations | Laboratory operations must include procedures for sampling, testing, data recording, and review to ensure reliable analytical results. | SOP-QCL-TEST SOP-QCL-DATA |
Lab notebooks Instrument logs Analytical worksheets |
| R-111.320 | 111.320 — Laboratory Testing Requirements | Components, in-process materials, and finished batches must be tested as appropriate to ensure compliance with specifications. | SOP-QCL-TEST SOP-QCP-SAMPLE SOP-QCP-IPC SOP-QA-REL |
Component test reports In-process test logs Finished product COAs |
| R-111.325 | 111.325 — Testing & Approval of Specifications | Specifications for testing must be established and approved, including methods, sampling plans, and acceptance criteria for all materials. | SOP-QA-SPEC-PROGRAM SOP-QCL-TEST SOP-QCL-DATA |
Specification sheets Method validation records |
| R-111.330 | 111.330 — Disposition After Testing | Any material failing to meet specifications must be rejected and controlled to prevent unintended use. | SOP-QA-NCMR SOP-QA-REL SOP-QA-DEV |
Rejection records Disposition documentation |
| R-111.335 | 111.335 — Out-of-Specification (OOS) Investigations | Laboratory must investigate OOS or OOT results, including root cause determination, re-testing, and impact assessment. | SOP-QCL-DATA SOP-QA-DEV SOP-QA-CAPA |
OOS reports CAPA files Analytical review logs |
| R-111.340 | 111.340 — Laboratory Records | Records of laboratory tests must include sample identification, methods used, results, calculations, and signatures of analysts and reviewers. | SOP-QCL-DATA SOP-QCL-TEST SOP-QA-DC |
Lab data packets Analyst/reviewer signatures Data retention logs |
| ID | 21 CFR Citation | Requirement Summary | Primary SOPs | Evidence (AA) |
|---|---|---|---|---|
| R-111.353 | 111.353 — Requirements for Manufacturing Operations | Manufacturing operations must be conducted under conditions that prevent mixups, contamination, and ensure consistent product quality. | SOP-PROD-WEIGH SOP-PROD-BLEND SOP-PROD-ENCAP SOP-PKG-PACK SOP-PROD-PREOP SOP-SAN-CLEAN SOP-MH-SEG |
Batch records Pre-op checklists Sanitation logs |
| R-111.355 | 111.355 — Use of Lubricants & Chemicals | Only food-grade or approved lubricants and processing aids may be used, with controls to prevent contamination. | SOP-PROD-PREOP SOP-MAINT-PM SOP-SAN-CLEAN |
Lubricant specification sheets Maintenance logs |
| R-111.360 | 111.360 — Prevention of Contamination & Mixups | Operations must prevent contamination by microorganisms, foreign material, chemicals, and allergens, through adequate equipment and facility controls. | SOP-PROD-FMCONTROL SOP-SAN-CLEAN SOP-SAN-MASTER SOP-MH-SEG SOP-PROD-PREOP |
Foreign material logs Allergen segregation logs Cleaning documentation |
| R-111.365 | 111.365 — Cross-Contamination & Allergen Controls | Manufacturing processes must include controls to prevent cross-contact, including allergen controls, equipment cleaning, and product sequencing. | SOP-PROD-FMCONTROL SOP-SAN-MASTER SOP-SAN-CLEAN SOP-MH-SEG |
Allergen control logs Cleaning validation reports |
| R-111.370 | 111.370 — Material Movement Controls | Work-in-process materials must be handled and moved in a way that prevents mixups, contamination, and improper identification. | SOP-MH-HANDLING SOP-MH-SEG SOP-WH-STOR SOP-WH-INVT SOP-PROD-WEIGH |
Material movement logs Status tags Traceability records |
| ID | 21 CFR Citation | Requirement Summary | Primary SOPs | Evidence (AA) |
|---|---|---|---|---|
| R-111.410 | 111.410 — Label Control System | Establish a label control system that includes issuance, reconciliation, storage, and approval of labels to prevent mixups and mislabeling. | SOP-PKG-LABEL SOP-QA-REL SOP-QA-DC |
Label issuance logs Label reconciliation records |
| R-111.415 | 111.415 — Packaging & Labeling Operations | Packaging operations must ensure correct packaging materials are used, container/closure integrity is maintained, and labeling is accurate. | SOP-PKG-PACK SOP-PKG-SETUP SOP-PKG-CLEAN SOP-PROD-PREOP SOP-QCP-IPC |
Packaging batch records Line setup verification forms |
| R-111.420 | 111.420 — Fill & Packaging Controls | Includes requirements for ensuring correct fill weight/count, preventing contamination, and maintaining container/closure integrity. | SOP-PKG-PACK SOP-PROD-WEIGH SOP-QCP-IPC |
Fill weight logs Container/closure inspection records |
| R-111.430 | 111.430 — Labeling Operations & Labeling Checks | Labels must be verified for accuracy, correct application, correct lot coding, and must match the product being packaged. | SOP-PKG-LABEL SOP-PKG-PACK SOP-PKG-SETUP SOP-QCP-IPC SOP-QA-REL |
Label verification logs Label reconciliation reports |
| ID | 21 CFR Citation | Requirement Summary | Primary SOPs | Evidence (AA) |
|---|---|---|---|---|
| R-111.503 | 111.503 — Returned Product Handling | Returned dietary supplements must be identified, quarantined, and evaluated to determine whether they may be salvaged, reprocessed, or must be destroyed. | SOP-QA-RETURNS SOP-WH-STOR SOP-WH-INVT SOP-QA-REL |
Return log Quarantine records Evaluation forms |
| R-111.510 | 111.510 — Returned Product Investigation | Each returned product must undergo documented evaluation to determine cause of return and whether the product may have been compromised. | SOP-QA-RETURNS SOP-QA-DEV SOP-QA-CAPA SOP-QCL-DATA |
Return evaluation forms Deviation reports CAPA files |
| R-111.515 | 111.515 — Returned Product Disposition | QC must approve disposition decisions for returned product, including reprocessing, salvage, return to inventory, or destruction. | SOP-QA-RETURNS SOP-QA-REL SOP-QA-NCMR |
Disposition approvals Destruction records |
| R-111.520 | 111.520 — Salvage | Procedures must ensure salvage operations (recovery of product or components) prevent adulteration and preserve product quality. | SOP-QA-RETURNS SOP-SAN-CLEAN SOP-WH-STOR |
Salvage logs Cleaning records QC approval |
| R-111.530 | 111.530 — Reprocessing Controls | Reprocessing must be fully documented, scientifically justified, approved by QC, and must result in a product meeting all specifications. | SOP-QA-RETURNS SOP-QA-REL SOP-PROD-BATCH SOP-QA-DEV |
Reprocessing justification BPR addendum QC review |
| R-111.535 | 111.535 — Material Review & Disposition (MRB) | Materials failing to meet specifications must undergo MRB review, including QC evaluation and controlled disposition per documented procedures. | SOP-QA-NCMR SOP-QA-DEV SOP-QA-CAPA SOP-QA-REL |
MRB forms QC disposition logs |
| R-111.560 | 111.560 — Complaint Handling | Consumer complaints must be recorded, evaluated, and investigated to determine whether product quality, labeling, or manufacturing contributed to the issue. | SOP-QA-COMPLAINT SOP-QA-DEV SOP-QA-CAPA SOP-QA-RETURNS |
Complaint log Investigation files Trend reports |
| R-111.570 | 111.570 — Salvage & Reconditioning Controls | Any salvage or reconditioning must be controlled and validated to ensure the resulting product meets all safety and quality standards. | SOP-QA-RETURNS SOP-QA-REL SOP-QA-CAPA |
Salvage records QC approvals Reprocessing validations |
| ID | 21 CFR Citation | Requirement Summary | Primary SOPs | Evidence (AA) |
|---|---|---|---|---|
| R-111.603 | 111.603 — General Recordkeeping Requirements | Records must be accurate, legible, indelible, and created at the time of performance. Applies to all manufacturing, packaging, labeling, holding, and testing activities. | SOP-QA-DC SOP-IT-ACCESS SOP-IT-ESIG SOP-PROD-BATCH SOP-QCL-DATA |
Controlled records Timestamped entries Audit trail reports |
| R-111.605 | 111.605 — Required Content of Records | Records must contain all required information, including dates, signatures, identification of material, and results of tests or operations performed. | Inherited from L0 Governance SOP-QA-DC SOP-PROD-BATCH SOP-QCL-DATA |
Controlled forms Completed batch records Lab data packets |
| R-111.610(a) | 111.610(a) — Record Retention Period | Records must be retained for at least 1 year past the shelf life date or 2 years beyond distribution of the last batch, whichever is longer. | SOP-QA-DC SOP-IT-BACKUP SOP-QCL-DATA SOP-WH-INVT |
Record retention logs Archival documentation |
| R-111.610(b) | 111.610(b) — Accessibility of Records | Records must be readily retrievable for inspection and must be stored to protect against deterioration, loss, or unauthorized access. | SOP-QA-DC SOP-IT-ACCESS SOP-IT-BACKUP |
Record archives Access logs Backup restoration reports |
| R-111.610(c) | 111.610(c) — Electronic Records & Backups | Electronic systems used for recordkeeping must ensure accuracy, integrity, security, and reliable backup to prevent data loss. (Cross-ref: 111.35(b)(5)). | SOP-IT-ACCESS SOP-IT-BACKUP SOP-IT-ESIG SOP-IT-VALIDATE |
Backup logs System validation reports Access control records |
| ID | 21 CFR Citation | Requirement Summary | Primary SOPs | Evidence (AA) |
|---|---|---|---|---|
| R-111.560 | 111.560 — Complaint Handling Requirements | Product complaints must be reviewed, evaluated, and investigated when necessary. QC/QA must determine whether the complaint involves possible failure of product quality, packaging, labeling, or manufacturing. | SOP-QA-COMPLAINT SOP-QA-DEV SOP-QA-CAPA SOP-QA-RETURNS SOP-QCL-DATA |
Complaint log Investigation reports CAPA files Trend analysis |
| R-111.560(a) | 111.560(a) — Investigation Decision Criteria | Each complaint must be classified and evaluated to determine whether it requires investigation. Investigations are mandatory if the complaint suggests a deviation, contamination, mislabeling, or health risk. | SOP-QA-COMPLAINT SOP-QA-DEV SOP-QA-CAPA |
Complaint evaluation forms Severity classification logs |
| R-111.560(b) | 111.560(b) — Complaint Investigation Requirements | If an investigation is required, it must be documented and must include batch review, test data review, prior complaint history, and corrective actions as applicable. | SOP-QA-COMPLAINT SOP-QA-DEV SOP-QA-CAPA SOP-PROD-BATCH SOP-QCL-DATA |
Investigation reports BPR review documentation OOS/OOT checks |
| R-111.560(c) | 111.560(c) — Complaint Record Content | Complaint records must include: description of complaint, batch/Lot number, actions taken, investigation results, findings, and final QC/QA disposition. | SOP-QA-COMPLAINT SOP-QA-DC SOP-QA-REL |
Complaint files Disposition documentation Record retention logs |
| R-111.560(d) | 111.560(d) — Complaint Escalation & Related Actions | Complaints indicating potential adulteration or mislabeling may require escalation to return product evaluation, reprocessing, or recall assessment. | SOP-QA-RETURNS SOP-QA-RECALL SOP-QA-CAPA SOP-QA-DEV |
Escalation records Recall assessment forms CAPA initiation logs |
| ID | 21 CFR Citation | Requirement Summary | Primary SOPs | Evidence (AA) |
|---|---|---|---|---|
| R-111.1 | 111.1 — Applicability | Establishes that 21 CFR 111 applies to manufacturers, packers, and holders of dietary supplements. | Inherited from L0 Governance (No SOPs should map directly) | QMS governance documentation Regulatory scope statements |
| R-111.3 | 111.3 — Definitions | Provides definitions for terms used throughout 21 CFR 111, including component, dietary ingredient, in-process material, quality control, etc. | Inherited from L0 Governance (No SOPs should map directly) | Global definitions index Document glossary references |
| R-111.5 | 111.5 — Personnel Responsibilities | Personnel engaged in manufacturing, packaging, labeling, or holding must comply with applicable requirements to prevent adulteration. | SOP-PROD-HYGIENE SOP-SAN-EMP SOP-TAL-TRAIN SOP-TAL-COMP SOP-TAL-QUAL | Training files Hygiene inspection logs Competency assessments |
| Cross-ref to R-111.8 | 111.8 — Illness & Disease Control | This requirement is fully governed under Subpart B; included in Subpart A only for completeness of scope mapping. | (See Subpart B — R-111.8) | Illness reporting logs Exclusion records |
| Cross-ref to R-111.10 | 111.10 — Personnel Hygiene Practices | General hygiene requirements applicable to all personnel; fully governed under Subpart B. | (See Subpart B — R-111.10) | Training records Hygiene logs |
| Cross-ref to R-111.12 | 111.12 — Personnel Qualifications | Personnel must have training, education, and experience necessary to perform assigned functions; fully handled in Subpart B. | (See Subpart B — R-111.12) | Training files Qualification records |
| Cross-ref to R-111.14 | 111.14 — Supervisor Responsibilities | Supervisors must ensure compliance with CGMPs and proper performance of assigned duties; fully handled under Subpart B. | (See Subpart B — R-111.14) | Supervisor oversight logs Training oversight records |
This table maps all relevant requirements from NSF/ANSI 455-2 to SNL’s SOPs (WHAT) and the associated Auditable Evidence (AA) generated through WIN and FORM execution. All citations are controlled at Level 0; SOPs, WINs, and FORMs must not duplicate regulatory references.
Format:
Citations:
| ID | Clause | Requirement Summary | Primary SOPs | Evidence (AA) |
|---|---|---|---|---|
| N-4.1.1 | 4.1.1 — Supplier Qualification & Monitoring | Requires evaluation, qualification, and ongoing monitoring of suppliers of components, packaging, and critical materials that impact product quality or safety. | SOP-PROC-QUAL SOP-PROC-ASL |
Supplier files Approved Supplier List (ASL) Supplier audit reports |
| N-4.1.3 | 4.1.3 — COA Verification & Supplier Documentation Review | Requires review of supplier documentation and verification that Certificates of Analysis (COAs) match specifications before use. | SOP-WH-RECV SOP-PROC-DOCS SOP-QA-SPEC-PROGRAM |
COA verification logs Receiving inspection records Spec-to-COA match documentation |
| ID | Clause | Summary | Primary SOPs | Evidence |
|---|---|---|---|---|
| N-4.2.1 | 4.2.1 — Storage Conditions & Material Protection | Requires materials to be stored under defined conditions that prevent contamination, deterioration, or mixups. | SOP-WH-STOR SOP-WH-INVT |
Storage logs Temp/humidity records (as applicable) Material status tags |
| N-4.2.3 | 4.2.3 — Environmental Controls & Sanitation | Requires sanitation programs, ATP verification (if used), and environmental controls appropriate for dry-processing. | SOP-SAN-MASTER SOP-SAN-CLEAN SOP-SAN-EMP |
Sanitation logs ATP results Environmental inspection records |
| N-4.2.8 | 4.2.8 — Personnel Hygiene Requirements | Requires personnel to maintain hygiene standards appropriate to prevent contamination of materials or product. | SOP-PROD-HYGIENE SOP-SAN-EMP |
Training records Hygiene inspections |
| N-4.2.9 | 4.2.9 — Employee Illness Reporting | Requires personnel to report health conditions that could pose contamination risks and requires the facility to maintain controls for exclusion. | SOP-PROD-HYGIENE |
Illness reporting log Exclusion records |
| N-4.2.10 | 4.2.10 — Hygienic Practices | Requires hygienic conduct such as handwashing, protective garments, restrictions on jewelry, food, and drink. | SOP-PROD-HYGIENE SOP-SAN-EMP |
Hygiene assessments Training documentation |
| N-4.2.11 | 4.2.11 — GMP Personnel Qualifications | Requires adequate training, competency, and qualification of all personnel performing GMP activities. | SOP-TAL-TRAIN SOP-TAL-COMP SOP-TAL-QUAL |
Training files Competency assessments |
| ID | Clause | Summary | Primary SOPs | Evidence |
|---|---|---|---|---|
| N-4.3.1 | 4.3.1 — Production Process Controls | Requires documented controls for weighing, blending, encapsulation, and packaging to ensure consistency and prevent contamination. | SOP-PROD-WEIGH SOP-PROD-BLEND SOP-PROD-ENCAP SOP-PKG-PACK |
Batch production records IPC logs |
| N-4.3.2 | 4.3.2 — Traceability & Lot Control | Requires complete traceability of components, WIP, and finished goods, including lot identification and status tracking. | SOP-WH-STOR SOP-WH-INVT SOP-MH-HANDLING |
Lot tracking logs WIP status tags |
| N-4.3.3 | 4.3.3 — Contamination, Foreign Material & Allergen Controls | Requires controls for cross-contact, foreign material prevention, and allergen handling appropriate to dry operations. | SOP-PROD-FMCONTROL SOP-SAN-MASTER SOP-MH-SEG |
FM control logs Allergen segregation records Cleaning verification |
| ID | Clause | Summary | Primary SOPs | Evidence (AA) |
|---|---|---|---|---|
| N-4.4.24 | 4.4.24 — Pest Prevention Requirements | Requires a preventive pest program, including elimination of harborages, proper waste handling, and facility design practices that deter pests. | SOP-SAN-PEST SOP-SAN-MASTER |
Pest inspection forms Facility sanitation inspection logs |
| N-4.4.25 | 4.4.25 — Pest Control Program | Requires a documented pest control program performed by trained personnel or licensed external providers. | SOP-SAN-PEST |
Pest control service records Trap maps Monthly service reports |
| N-4.4.26 | 4.4.26 — Pest Control Documentation | Requires documentation supporting monitoring activities, corrective actions, trends, and contractor qualifications. | SOP-SAN-PEST SOP-QA-DC |
Pest trend reports Service logs Corrective action records |
| N-4.4.27 | 4.4.27 — Water System Controls (Non-Product Contact) | Requires water used for sanitation or facility cleaning to be managed under appropriate maintenance and sanitation controls (dry facility exemption applied). | SOP-SAN-MASTER SOP-MAINT-FACILITY |
Sanitation logs Maintenance records |
| N-4.4.28 | 4.4.28 — Compressed Air Quality (If Used) | Requires compressed air used in cleaning, conveying, or product-contact operations to be filtered and monitored to prevent contamination. | SOP-MAINT-CAL SOP-MAINT-FACILITY |
Preventive maintenance logs Filter change records |
| N-4.4.29 | 4.4.29 — HVAC Controls | Requires HVAC systems to maintain environmental conditions appropriate for dry manufacturing, preventing dust accumulation and cross-contamination. | SOP-MAINT-FACILITY SOP-SAN-MASTER |
HVAC service logs Differential pressure logs (if applicable) |
| N-4.4.30 | 4.4.30 — Utility Documentation | Requires documentation for utilities that may impact product safety or quality (electric, air, water, HVAC). | SOP-MAINT-FACILITY SOP-QA-DC |
Utility inspection logs Maintenance records |
| ID | Clause | Summary | Primary SOPs | Evidence |
|---|---|---|---|---|
| N-4.5.2 | 4.5.2 — Equipment Maintenance | Requires routine and preventive maintenance of equipment to ensure proper function and prevent contamination or mixups. | SOP-MAINT-PM SOP-MAINT-FACILITY |
Maintenance logs PM schedules |
| N-4.5.3 | 4.5.3 — Calibration Program | Requires a documented program for calibration of instruments used in weighing, blending, in-process testing, and packaging operations. | SOP-MAINT-CAL SOP-MAINT-CAL-PROGRAM SOP-QA-DEV |
Calibration certificates Calibration logs Out-of-tolerance (OOT) investigations |
| N-4.5.23 | 4.5.23 — Packaging Area Sanitation | Requires packaging areas to be cleaned and inspected to prevent material buildup, contamination, or label mixups. | SOP-PKG-CLEAN SOP-SAN-MASTER |
Cleaning logs Pre-op inspection forms |
| ID | Clause | Summary | Primary SOPs | Evidence |
|---|---|---|---|---|
| N-4.6.1 | 4.6.1 — Laboratory Control System | Requires controls for laboratory testing activities, including ingredient identity testing and review of lab results. | SOP-QCL-TEST SOP-QCL-DATA |
FTIR identity test logs COA comparison documentation |
| N-4.6.3 | 4.6.3 — Analytical Testing Controls | Requires scientifically valid methods and proper controls for outsourced analytical testing (strength, purity, micro, heavy metals). | SOP-QCL-TEST SOP-PROC-DOCS SOP-QA-SPEC-PROGRAM |
Third-party test reports Vendor qualification files |
| N-4.6.4 | 4.6.4 — OOS/OOT Investigation Requirements | Requires investigation of out-of-specification or out-of-trend results with documented root cause and corrective actions. | SOP-QCL-DATA SOP-QA-DEV SOP-QA-CAPA |
OOS/OOT logs Investigation reports CAPA records |
| ID | Clause | Summary | Primary SOPs | Evidence (AA) |
|---|---|---|---|---|
| N-4.10 | 4.10 — Returned Product Controls | Returned products must be identified, quarantined, evaluated, and documented to determine whether they may be salvaged, reprocessed, or destroyed. | SOP-QA-RETURNS SOP-WH-STOR SOP-WH-INVT SOP-QA-REL |
Return logs Quarantine records Evaluation forms |
| N-4.11 | 4.11 — Reprocessing & Salvage Requirements | Reprocessing must be scientifically justified, approved by QA, and fully documented. Salvage activities must not risk adulteration or contamination. | SOP-QA-RETURNS SOP-QA-DEV SOP-QA-CAPA SOP-QA-REL |
Reprocessing justification CAPA or deviation links QA approval documentation |
| ID | Clause | Summary | Primary SOPs | Evidence |
|---|---|---|---|---|
| N-5.1.1 | 5.1.1 — Recordkeeping Requirements | Records must be accurate, indelible, legible, complete, and created at the time of performance. Applies to all operations. | L0 Governance (Recordkeeping Rules) SOP-QA-DC SOP-IT-ESIG SOP-IT-ACCESS SOP-PROD-BATCH SOP-QCL-DATA |
Controlled records Audit trail logs Timestamped entries |
| N-5.1.2 | 5.1.2 — Documentation Integrity (ALCOA+) | Documentation must follow ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available). | L0 Section 3.2 (ALCOA+) SOP-QA-DC SOP-IT-ESIG |
Controlled document set Signature logs Training records |
| ID | Clause | Summary | Primary SOPs | Evidence |
|---|---|---|---|---|
| N-5.2.1 | 5.2.1 — Management Review | Requires periodic management review of the quality system, including CAPA trends, deviations, complaints, supplier status, and audit results. | SOP-QA-MGMTREV |
Management review minutes Quality performance dashboards |
| N-5.2.2 | 5.2.2 — Internal Audits | Requires a documented internal audit program covering all applicable NSF and CFR requirements at defined intervals. | SOP-QA-IA |
Audit schedules Audit reports CAPA follow-up records |
| ID | Clause | Summary | Primary SOPs | Evidence |
|---|---|---|---|---|
| N-5.3.1 | 5.3.1 — Deviations & Nonconformities | Requires identification, documentation, investigation, and segregation of nonconforming materials, processes, or results. | SOP-QA-DEV SOP-QA-NCMR SOP-QA-CAPA |
Deviation reports MRB forms Investigation summaries |
| N-5.3.3 | 5.3.3 — Corrective & Preventive Actions (CAPA) | Requires root cause analysis, corrective action planning, effectiveness checks, and closure approval by QA. | SOP-QA-CAPA SOP-QA-DEV |
CAPA logs Effectiveness checks Root cause documentation |
| ID | Clause | Summary | Primary SOPs | Evidence |
|---|---|---|---|---|
| N-5.4.1 | 5.4.1 — Complaint System | Requires documentation, evaluation, investigation, trending, and escalation of consumer complaints. | SOP-QA-COMPLAINT SOP-QA-DEV SOP-QA-CAPA |
Complaint log Investigation files Trend reports |
| ID | Clause | Summary | Primary SOPs | Evidence |
|---|---|---|---|---|
| N-5.5.3 | 5.5.3 — Change Control | Requires a controlled process for evaluating, approving, implementing, and documenting changes to procedures, materials, specifications, or systems. | SOP-QA-CC |
Change control records Impact assessments Approval signatures |
The following clauses do not apply to SNL operations due to the facility’s dry-processing scope and operational boundaries. These items relate to wet processing, thermal processing, CIP/SIP systems, full analytical laboratories, or utilities not used in SNL’s processes.
This table maps all relevant requirements from NSF/ANSI 455-2 to SNL’s SOPs (WHAT) and the associated Auditable Evidence (AA) generated through WIN and FORM execution. All citations are controlled at Level 0; SOPs, WINs, and FORMs must not duplicate regulatory references.
SNL's Risk Model is defined below.
Risk Tiers:
| PROCESS | Description | Why High Risk? | SNL SOPs |
|---|---|---|---|
| PROD — Production | Weighing, blending, encapsulation, line clearance, foreign-material control | Direct impact on product identity, purity, strength, and contamination |
SOP-PROD-HYGIENE SOP-PROD-PREOP SOP-PROD-MMR SOP-PROD-BLEND SOP-PROD-ENCAP SOP-PROD-CLEAN SOP-PROD-BATCH SOP-PROD-WEIGH SOP-PROD-FMCONTROL |
| PKG — Packaging | Label control, packaging operations, reconciliation, line clearance | Mislabeling risk; final product integrity; reconciliation failures |
SOP-PKG-SETUP SOP-PKG-LABEL SOP-PKG-PACK SOP-PKG-CLEAN |
| QCP — QC (Production-Facing) | Sampling, in-process testing, identity checks | Direct impact on batch validity and release readiness |
SOP-QCP-SAMPLE SOP-QCP-IPC |
| QCL — QC Laboratory | Analytical testing, micro testing, OOS/OOT investigations | Determines product compliance; analytical and micro risks |
SOP-QCL-TEST SOP-QCL-DATA |
| SAN — Sanitation | Cleaning, allergen control, environmental monitoring | Cross-contamination, allergen risk, micro contamination |
SOP-SAN-CLEAN SOP-SAN-MASTER SOP-SAN-EMP SOP-SAN-PEST |
| QA — Quality Assurance | Release, deviations, CAPA, complaint handling | Direct impact on product disposition, investigations, risk remediation |
SOP-QA-REL SOP-QA-DEV SOP-QA-CAPA SOP-QA-DC SOP-QA-CC SOP-QA-COMPLAINT SOP-QA-RECALL SOP-QA-IA SOP-QA-MGMTREV SOP-QA-SPEC-PROGRAM SOP-QA-NCMR SOP-QA-STABILITY SOP-QA-SAMPLING-PROGRAM SOP-QA-RESERVESAMPLES SOP-QA-RETURNS |
| PROCESS | Description | Why Medium Risk? | SNL SOPs |
|---|---|---|---|
| PROC — Procurement | Supplier qualification, ASL management, supplier documentation | Bad suppliers → high-risk materials; risk is upstream but critical |
SOP-PROC-SOURCE SOP-PROC-QUAL SOP-PROC-ASL SOP-PROC-P2P SOP-PROC-DOCS |
| WH — Warehouse | Receiving, storage, segregation, inventory control, shipping | Improper storage, mix-ups, or mislabeling of materials impact production |
SOP-WH-RACKMAP SOP-WH-RECV SOP-WH-STOR SOP-WH-INVT SOP-WH-SHIP SOP-WH-TRANS |
| MH — Material Handling | Internal material movement, segregation, status control | Mix-ups or unlabeled material movement cascade into high-risk failures |
SOP-MH-HANDLING SOP-MH-SEG |
| MAINT — Maintenance | Preventive maintenance, calibration | Equipment failure impacts manufacturing accuracy and safety |
SOP-MAINT-PM SOP-MAINT-CAL SOP-MAINT-CAL-PROGRAM SOP-MAINT-FACILTIY SOP-MAINT-UTILITIES |
| EHS — Environmental Health & Safety | Safety, environmental monitoring, hazard controls | Facility-level risks impact environmental control and personnel safety | No dedicated EHS SOPs listed in SNL hierarchy |
| PROCESS | Description | Why Low Risk? | SNL SOPs |
|---|---|---|---|
| TAL — Training & Talent Development | Training, qualification, competency assessments | Indirect product impact; supports personnel compliance |
SOP-TAL-TRAIN SOP-TAL-COMP SOP-TAL-QUAL |
| IT — Information Technology | Access control, e-signatures, backups, validation | Indirect product impact, but critical to data integrity |
SOP-IT-ACCESS SOP-IT-ESIG SOP-IT-BACKUP SOP-IT-VALIDATE |
| DOC — Document Control | Document approvals, revisions, control status | System-level compliance; indirect product impact | SOP-QA-DC |