This module provides specific guidance on protecting dietary supplement products from contamination and adulteration during the manufacturing process. It identifies the most common sources of contamination and how to prevent. This module covers the following subparts of 21 CFR 111 with insights on how to design your quality program, facility and equipment to assure that finished product specifications are met:
o Subpart B – Personnel
o Subpart C – Plants and Grounds
o Subpart D – Equipment and Utensils
At the end of this module you should be able to:
- Identify the most common sources of microbial contamination
- Recognize how proper design of a facility can help prevent contamination and adulteration
- Recognize the importance of defining the tools to be used in the production process and keeping them clean and sanitized, in good working order and calibrated.
- Explain the difference between cleaning and sanitization
- Recognize the importance of accuracy and precision in a measurement
By completing/passing this course, you will attain the certificate DS Certificate
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