According to the FDA, “If it wasn’t written down, it didn’t happen.” Record keeping and documentation are a key component for compliance to 21 CFR 111. This course walks through the regulation, providing guidance on the necessary documentation and tools for compliance.
Through the Current Good Manufacturing Practices for Dietary Supplements Regulations that were enacted in June of 2007, the Food and Drug Administration has established industry-wide standards to ensure identity, purity, strength, and composition of manufactured dietary supplements. The regulations are specific with respect to the procedures that must be in place, and the records that must be maintained in support of those procedures; however, they are somewhat vague and don’t offer clear guidelines for achieving compliance. In addition, companies are left to determine the level of compliance that they need to put in place, and the frequencies for tasks that must be performed in order to continue to comply with the regulations.