This module covers the requirements for packaging and labeling systems, applicable even if these are the only operations at your facility. Also covered in this module are the requirements for warehousing and distribution of dietary supplements and the FDA regulations for procedures involving product complaints and returns. The following subparts of 21 CFR 111 are covered:
o Subpart G – Components, Packaging, and Label Control
o Subpart L – Packaging and Labeling Control System
o Subpart M – Holding and Distributing
o Subpart N – Returns
o Subpart O – Complaints
At the end of this module you should be able to:
- Recognize the importance of label control and implementation
- Recognize the importance of environmental monitoring in holding and distribution operations
- Identify requirements and procedures for handling returned products
- Explain the process for handling product complaint
- Identify what to expect in an FDA Inspection and what is exempt
- Explain how to implement cGMPs at your facility
By completing/passing this course, you will attain the certificate DS Certificate
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