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.

Scope of Work

GMP SOP Template Package

Provide FDA-aligned standard operating procedures (SOPs), policies, and work instructions formatted to 21 CFR Part 111 and delivered as editable Word and PDF files. Templates are suitable for immediate use or customization to internal workflows.

Quality System SOPs

Develop SOP templates supporting each functional area required under 21 CFR 111:

• Personnel Qualification and Responsibilities
• Physical
• Plant and Grounds Maintenance
• Equipment, Utensils, and Cleaning
• Production and Process Controls
• Component, Packaging, and Label Controls
• Holding and Distribution
• Laboratory Operations (if applicable)
• Quality Control Operations
• Returned and Salvaged Product Handling
• Complaint Handling and CAPA Procedures
• Records Management and Retention

Forms, Checklists, and Support Documents Provide relevant logs, registers, and forms necessary to support implementation of the SOPs, including:

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

Training Support (Optional)

Clients may add an optional Training Materials Package that includes training decks, quizzes, acknowledgment forms, and a rollout schedule per SOP section.

Customization Support (Optional)

Client branding, staff role mapping, and workflow terminology can be integrated into the SOPs for an additional one-time customization fee.

Deliverables

SOP Documentation Package

Fully formatted SOPs tailored to 21 CFR Part 111 requirements:

• Provided in both Word and PDF formats
• Each SOP includes document headers, version controls, and cross-reference sections
• Includes a Master SOP Index and Implementation Guide

Forms & Registers

A set of at least 20 support documents including:

• Audit Checklists
• Quality System Logs
• CAPA Forms
• Training Logs
• Master Document Index

Customization Guide

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

Fees and Subscriptions

Standard Documentation Package – $1,750.00 (One-Time Fee)

Includes:

• Complete SOP set covering all major 21 CFR 111 requirements • Forms, logs, and checklists • Implementation guidance and document control tools

Add-Ons:

• SOP Customization Support: +$300 • Training Materials Package: +$275 • Additional Recordkeeping Forms Bundle: +$225 • Audit Readiness Walkthrough (1-hour Zoom): +$150 • Annual SOP Update Package: +$475/year • Master Binder Setup (digital or print-ready): +$200

Ideal For:

• Dietary supplement brands building or upgrading quality documentation systems • Startups preparing for FDA inspections or third-party certifications (NSF, UL, SQF) • Importers subject to FSVP documentation verification under 21 CFR 1.500-1.514 • Co-manufacturers seeking to align documentation with contract requirements or retail buyer expectations