Session Details

Description

Entering the dietary supplement market as a startup, facility design for GMP compliance training will cover how to create a facility that adheres to industry standards. We will discuss facility design for GMP compliance, sources of contamination and how to prevent them. The FDA expects all companies that manufacture, package, or hold dietary supplement products to follow 21 CFR 111, the Dietary Supplement CGMPs.

Course Outline:

Facility Design

• Sources of Contamination
• Distinct Hygienic Zones
• Site
• Building Envelope
• Personnel & Material Flows
• Interior Spatial Design
• Building Components & Construction
• Utility Systems
• Water Management
• Room Temperature & Humidity
• Room Air Quality & Flow

Equipment Design

• Cleanable to a microbiological level
• Made of compatible materials
• Accessible for inspection, maintenance, cleaning, and sanitation
• No product or liquid collection
• Hermetically sealed hollow areas
• No niches
• Sanitary operational performance
• Hygienic design of maintenance enclosures
• Hygienic compatibility with other plant systems
• Verified cleaning and sanitizing procedures

Types of water

Types of Cleaning

This course is geared to those individuals involved in the dietary supplement industry or looking to enter the industry including:

• Management
• Manufacturing
• Quality Control/Assurance
• Packaging 
• Marketing
• Laboratory Operations
• Auditing
• Suppliers and Distributors
• Regulatory Affairs

*Note: SupplySide West & Food ingredients North America registration is required to register for this course. Click here to register for this year’s event and available GMP courses.

Produced by:

• GMP and Regulatory Compliance Training Program