Skip to content

PCQI vs. Dietary Supplement CGMP: Understanding FDA Requirements for Food Safety and Supplement Manufacturing

Classify the product before applying Part 117

Determine whether the product is a conventional food or dietary supplement. Classification affects whether Part 117 preventive controls or Part 111 CGMP requirements apply.

Understand the Part 111 framework

Dietary supplement manufacturers must address applicable CGMP requirements covering personnel, physical plant, equipment, production and process controls, quality control, records, and other provisions.

Assess ingredient identity and specifications

Establish appropriate specifications and controls to ensure dietary ingredients and other components meet applicable identity, quality, purity, strength, and composition requirements.

Evaluate new dietary ingredient requirements separately

Determine whether an ingredient is a new dietary ingredient and whether a premarket notification is required. PCQI qualification or a food safety plan does not substitute for NDI compliance or ingredient safety substantiation.

Avoid misapplying preventive controls terminology

Do not assume a supplement facility needs a Part 117 PCQI solely because it manufactures ingestible products. Determine the regulatory category and relevant exemptions or additional activities.

Build an integrated compliance plan for mixed operations

Where a business manufactures both conventional foods and supplements, assess activities and products separately and maintain procedures and records required for each framework.

How Consultare Inc. Group Can Help

Consultare can support PCQI and preventive controls services for facilities and products subject to Part 117. For supplement operations, Consultare can help assess the distinction between Part 117 and Part 111, review supplement CGMP documentation, and identify ingredient or NDI-related regulatory questions.

Free Consultation

Need Help Managing Your PCQI Responsibilities?

Whether you are reviewing ingredient eligibility, supplier documentation, quality systems, or regulatory responsibilities, request a free consultation through PCQIServices.com. Discuss your products, suppliers, documentation, and compliance priorities with the Consultare team.

Start Building Your Compliance System

If you prefer to organize and manage your compliance activities yourself, you can also create a free SystemsBuilder account and begin building a structured system for your compliance documentation and processes.