Your brand is on the line. Your compliance shouldn't be a guess.

GMP Playbook delivers plug-and-play FDA compliance systems for dietary supplement and cosmetic brand owners. Flat-rate. Implemented in weeks, not months.

SOPs & Documentation

Editable Word templates, ready to customize

Quality Agreements

Manufacturer-ready contract templates

Batch Records & Specs

Production documentation that passes audits

FDA Warning Letter Shield

Documentation that keeps you off the list

21 CFR 111

Full compliance coverage for dietary supplements

30+ Years

Pharma compliance expertise (Pfizer, Sandoz, Novartis)

1-2 Months

From zero documentation to audit-ready

The Reality

You outsource manufacturing. The FDA doesn't care.

You're 100% responsible

Even if your contract manufacturer handles production, the FDA holds the brand owner fully accountable for GMP compliance. No exceptions.

Warning letters are public

When FDA issues a warning letter, it's published online. Retailers, distributors, and customers can all see it. One letter can end distribution deals overnight.

MoCRA changed everything

The Modernization of Cosmetics Regulation Act now requires GMP compliance for cosmetics manufacturers. A market that was largely unregulated now needs documentation.

Big consultants don't fit

Enterprise compliance firms charge $50K+ and take 6-12 months. Small and mid-size brands need something that works at their scale and budget.

The Playbooks

Three paths to compliance

Choose the playbook that matches your business model

01

Brand Owner Playbook

For companies that outsource all manufacturing and distribution.

  • Compliance SOPs and forms
  • Master label copy documentation
  • Finished product specifications
  • Quality agreement templates
02

Cosmetic Manufacturing

For small-scale cosmetics producers, aligned with FDA 2025 guidelines.

  • MoCRA-compliant documentation
  • Manufacturing SOPs and forms
  • Product specifications
  • Batch record templates
03

Supplement Manufacturing

For dietary supplement producers. Full 21 CFR Part 111 coverage.

  • Complete CGMP documentation
  • Food safety plans
  • Identity testing protocols
  • Deviation and CAPA procedures
The Expert

Built by someone who's lived inside the system

GMP Playbook was created by a compliance specialist with over three decades inside FDA-regulated facilities. From managing quality systems at global pharma companies to certifying CBD manufacturers, every template and procedure reflects real-world regulatory experience.

This isn't theoretical compliance advice. It's documentation that has been tested by auditors, inspectors, and the FDA itself.

Global Pharma

Senior quality leadership at top-5 pharmaceutical companies

Manufacturing Operations

Plant management and production oversight

CBD/Hemp Industry

Led compliance for the first CBD company in UNPA

Independent Consulting

Helping small brands achieve FDA compliance

GMP Playbook

Packaging decades of expertise into plug-and-play systems

Compliance shouldn't require a six-figure budget or a year-long timeline.

GMP Playbook puts 30 years of FDA regulatory expertise into a flat-rate package that small brands can implement in weeks. Your products deserve documentation that passes any audit.