SOP and Recordkeeping
The FDA's 21 CFR 111 is a performance-based regulation for the dietary supplement industry. If you manufacture, package, label or hold a dietary supplement, you must establish and follow Current Good Manufacturing Practices (cGMPs) to ensure the quality of the dietary supplement. You must also make sure that the dietary supplement is packaged and labeled as specified in the master manufacturing record. While cGMPs instruct you on what you need to accomplish, there is very little detail on how to go about it.
The good news is that you have a great deal of flexibility in how to accomplish the requirements outlined in the cGMPs. The downside is that you have to write SOPs that detail how you will meet those requirements. This training course will guide you through the construction of an SOP and recordkeeping system and then walk you through the process of creating SOPs and records.
Learning Outcomes
At the end of NSF's dietary supplement SOP training, you will know and understand:
- Requirements of the critical components for compliance with 21 CFR 111
- Recordkeeping requirements for compliance with 21 CFR 111
- How to construct your SOP system
- Your SOP on SOPs
- Locations and availability
- Writing SOPs
- Change control
- Part 11 (briefly)
- Records
- Forms
- Batch production records
- Dos and Don'ts
- Summary of required SOPs and records
Who Should Attend
- Management
- Marketing
- Quality control/assurance
- Packaging
- Sales
- Laboratory operations
- Product development
- Suppliers and distributors
- Regulatory affairs
- Legal
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