Good Manufacturing Practices for Natural Product Producers

Manufacturing dietary supplements can be challenging for natural product producers. The U.S. FDA expects all companies that manufacture, package or hold dietary supplement products to follow 21 CFR 111, the dietary supplement cGMPs.

This course provides a basic understanding of the cGMP requirements for all companies producing dietary supplements, with a focus on the natural product industries. The responsibilities expected from various individuals and groups within the company will be detailed, and you will learn how to apply cGMP principles to specific situations.

The course is interactive, with hands-on exercises that include case studies from recent warning letters issued to natural product producers. Bring your own questions and prepare to interact with the instructor and your industry peers.

The course will cover considerations for natural product producers on the following items:

• Basic Requirements of the cGMPs
• Records and Record Keeping
• Personnel, Buildings and Facilities
• Equipment Facility Records
• Production and Process Control
• Holding and Distribution
• Packaging and Labeling
• Quality Control and Quality Assurance
• Laboratory Operations
• Product Complaints

• Management
• Quality Control/Assurance
• Sales
• Product Development
• Marketing
• Packaging
• Laboratory Operations
• Suppliers and Distributors

Vijay Bachus – Vijay Bachus offers subject matter expertise in cGMP compliance related to 21 CFR Parts 111 and 117 to NSF Health Sciences. He is experienced in guiding top industry leaders through strategic growth and catapulting business owners to success. Vijay specializes in facility and business operations compliance. He holds a Bachelor of Science in molecular, cellular and developmental biology from the University of Colorado.