Dietary Supplement GMP Compliance SOP Templates

Compliance Documentation Based on 21 CFR Part 111 Requirements

To establish foundational compliance with FDA’s dietary supplement Good Manufacturing Practices (GMPs), this documentation package provides fully editable SOP templates aligned with 21 CFR Part 111. Designed for dietary supplement manufacturers, co-packers, and private labelers, these templates support key quality system functions, operational processes, and audit-readiness without ongoing subscription or review fees.

Ideal For:

• Dietary supplement brands building or improving quality management systems
• Startups preparing for FDA inspections or third-party certification (NSF, UL, SQF)
• Importers subject to FSVP documentation verification under 21 CFR 1.500–1.514
• Contract manufacturers aligning documentation with retail buyer or client requirements

Scope of Work

GMP SOP Template Package

• Provision of FDA-aligned Standard Operating Procedures (SOPs), policies, and work instructions tailored to 21 CFR Part 111.
• Delivered in fully editable Word and PDF formats.
• Ready for immediate use or customization to match internal operations.

Quality System SOPs and Training Materials covering the following key functional areas required under 21 CFR Part 111

• Personnel
• Physical Plant and Grounds
• Equipment and Utensils
• Requirement to Establish a Production and Process Control System
• Production and Process Control System: Requirements for Quality Control
• Production and Process Control System: Requirements for Components, Packaging, and Labels (if applicable)
• Laboratory Operations (if applicable)
• Production and Process Control System: Requirements for the Master Manufacturing Record (MMR) (if applicable)
• Production and Process Control System: Requirements for the Batch Production Record (BPR) (if applicable)
• Production and Process Control System: Requirements for Laboratory Operations (if applicable)
• Production and Process Control System: Requirements for Manufacturing Operations (if applicable)
• Production and Process Control System: Requirements for Packaging and Labeling Operations (if applicable)
• Holding and Distribution
• Returned Dietary Supplements
• Product Complaints
• Records and Recordkeeping

Forms, Checklists, and Supporting Documents, such as:

• Cleaning and Sanitation Logs
• Personnel Hygiene Oversight
• Equipment Calibration Checklists
• Product Release Forms
• Supplier Approval Forms
• Document Control Registers

Full Customization Support (Optional)

Customization services to align SOPs and supporting documents with client-specific operations, product lines, facility layouts, and organizational structure. Customization may include:

• Incorporation of client branding and logos
• Mapping of site-specific roles and responsibilities
• Tailoring of sections to fit the organization's needs and current processes
• Adjustment of process workflows and terminologies

Deliverables

21 CFR 111 Documentation Package

• Fully formatted programs, policies, procedures, forms for records, and lessons for training materials meeting 21 CFR Part 111 requirements
• Delivered in editable Word and PDF formats, ready for immediate use or customization to match internal operations.
• Includes:
- • Document headers and version control
- • Cross-references to applicable regulations
- • Record implementation guides

Forms and Registers to cover essential supporting documents such as:

• Inspection Checklists
• Quality System Logs
• CAPA Forms
• Training Logs
• Maintenance Checklists

Customization Guide

Instructional guide for internal teams to adapt SOPs to their specific operations, staffing, and production scale.

Fees and Subscriptions

Package Description Fee (USD) Action

Standard Documentation Package • Complete SOP template set covering all major 21 CFR Part 111 requirements
• Supporting forms, logs, and checklists
• Implementation guidance and document control tools $2,950.00
(one-time) Purchase

SOP Templates + Full Customization Support • Comprehensive customization of 21 CFR Part 111 SOPs, records, training materials, and checklists
• Tailored to client's operations, products, and organizational structure
• Implementation guidance and document control tools Custom Quote
(one-time) Purchase

Optional Add-Ons

• Annual SOP Update Package $1,499/year

• 21 CFR 117 Supply Chain Program Compliance SOP Toolkit $110.00

• Foreign Supplier Verification (FSVP) SOP Toolkit $1,550.00

• HACCP/Food Safety Plan Development $2,200.00 per product

• On-Site Support Visit $1,200.00/day + misc.

• GMP Readiness Gap Assessment (remote) $4,750.00/facility

• GMP Readiness Gap Assessment (onsite) $4,900.00/facility + misc.

Inquire