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Brand Owner Compliance SOP Templates Package

Ready-to-use DIY Package for Brand Owners

This SOP Template Package is designed for U.S. and international brand owners that require a documented quality system aligned with FDA regulations, but can manage with do-it-yourself implementation or PCQI oversight. These ready-to-use editable SOPs help meet regulatory expectations, distributor requirements, and audit readiness for food, beverage, or dietary supplement brands relying on third-party manufacturers or co-packers.

What’s Included

Supplier and Co-Manufacturer Management SOPs and records (programs, policies, procedures, forms, records, and lessons)

  • • Approved Supplier Program SOP (21 CFR 117.410)
  • • Supplier Evaluation Form Templates
  • • Internal Audit SOP for Co-Manufacturer Oversight (21 CFR 117.435)
  • • Co-Manufacturing Quality Agreement Template (21 CFR 117.335)
  • • Specifications Management SOP (21 CFR 117.475)
  • • Records Retention and Document Control SOP (21 CFR 117.315)

Product Compliance and Risk Program SOPs and records (programs, policies, procedures, forms, records, and lessons)

  • • Product Recall and Withdrawal SOP (21 CFR 117.139)
  • • Complaint Handling SOP (21 CFR 117.410(e))
  • • Crisis Management SOP (21 USC 301)
  • • HACCP/Food Safety Plan Template SOP (21 CFR 117.126)
  • • Food Fraud Vulnerability Assessment SOP + Food Defense Plan (21 CFR 121.130)
  • • Traceability Program SOP (21 CFR 1.1315)
  • • Label Version Control and Verifications (if applicable)

Optional, for importers: FSVP SOP Templates and records (programs, policies, procedures, forms, records, and lessons)

  • • Foreign Supplier Verification Activities SOP (21 CFR 1.502)
  • • Temporary Sourcing SOP (Emergency Supply Policy)
  • • FSVP Importer Evaluation Form
  • • FSVP Records Retention

Who it is for

  • • Brand owners needing documentation to demonstrate compliance
  • • Teams preparing for audits or distributor onboarding
  • • Private labelers or non-manufacturing entities
  • • Compliance managers building or updating their document library

Fees and Subscriptions

Package Timeline Price
Standard Brand Owner Compliance SOP Templates 15 to 20 business days $1,600.00
Add-on: PCQI Guardian Membership (4 hours of monthly compliance support) $99 per month
Add-on: Foreign Supplier Verification Programs for Food Importers SOP Templates 10 to 15 business days $1,550.00
Add-on: SOP Customization – Standard Brand Owner Compliance 30 to 45 business days $4,500.00
Add-on: Supply-chain/FSVP Compliance Assessment 5 to 10 business days $249 per supplier
Add-on: Food Fraud Vulnerability Assessment Set-up 5 to 10 business days $129 per product

Get Started

Need a professional, ready-to-edit documentation set without setup services? This package gives your team the foundation to meet FDA expectations across supplier control, risk programs, and product traceability. Contact us today to purchase the SOP Templates Package or request a sample table of contents. We will send you everything you need to begin documenting your compliance system with ease.

Contact us at info@consultareinc.com or submit your request via our online form.