Although dietary supplement manufacturers may be exempt from the preventative controls and supply chain program requirements of 21 CFR 117, raw material suppliers are not and many dietary supplement companies also manufacture products, such as meal replacements that are foods. These companies are not exempt and are required to have a written supply chain program as part of their food safety plan.
In this one-hour pre-recorded session we highlight the key requirements of 21 CFR 117 subpart G that are required for all raw material suppliers and any manufacturer that makes a product with a Nutrition Facts label. You will learn what the FSMA based supply chain programs have in common and differ from the supplier qualification requirements of 21 CFR 111, as well as what you and your raw material suppliers need to do to be compliant with this part of the regulation.
Learning Objectives:
- Understand what the components of a supply chain program
- Know where to find the new regulations
- Recognize the difference in supplier qualification requirements under 21 CFR 111 and 21 CFR 117 Subpart G
- Know what is required for supplier audits