Entering the Dietary Supplement Market as a Start-up – Facility Design for GMP Compliance
If you’re entering the nutritional supplement market as a start-up, this training on facility design for Good Manufacturing Practice (GMP) compliance will teach you how to create a facility that complies with industry standards and regulatory requirements. The FDA expects that all companies manufacturing, packaging or holding dietary supplement products to adhere to 21 CFR 111, the Dietary Supplement cGMPs.
Our experts will discuss facility design for GMP compliance, sources of contamination and how to prevent them.
Learning Outcomes
Key topics covered on this dietary Supplement facility design training includes:
Facility Design
- Sources of contamination
- Distinct hygienic zones
- Site
- Building envelope
- Personnel and material flows
- Interior spatial design
- Building components and construction
- Utility systems
- Water management
- Room temperature and humidity
- Room air quality and 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
- Clean-in-Place (CIP)
- Clean-Out-of-Place (COP)
- Manual
- Dry
- Flush
- None
Who Should Attend
This dietary supplement facility design training is suitable for:
- Entrepreneurs
- Management
- Manufacturing
- Quality control/assurance
- Packaging
- Marketing
- Laboratory operations
- Auditing
- Suppliers and distributors
- Regulatory affairs
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