This module provides a brief historical review of regulations in the dietary supplement industry and their evolution as key incidents exposed health and safety risks to the consumer. This module also covers the following subparts of 21 CFR 111 which create the foundation of your Quality Management System (QMS) and the good manufacturing practices that control product quality:
o Subpart A – General Provisions
o Subpart P – Records and Record Keeping
o Subpart H – Master Manufacturing Records
o Subpart I – Batch Production Record
At the end of this module you should be able to:
- Examine a brief history of cGMP’s to identify why they are important and necessary
- Recognize the difference between prescriptive and performance-based regulations
- Identify the importance of Dietary Supplement regulations and where they can be found
- Recognize how the manufacturing process determines product quality
- Identify records and documents required by the FDA for compliance with GMPs
- Define Master Manufacturing Record (MMR) & Batch Production Record (BPR)
By completing/passing this course, you will attain the certificate DS Certificate 7.26
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