The establishment of regulation 21 CFR part 111, or Current Good Manufacturing Practices, in the Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements requires persons involved in the manufacturer, packaging, labeling or holding of dietary supplements to follow certain practices to ensure quality.
Firms must maintain appropriate operating procedures and records for the running of the physical plants and grounds, equipment and utensils, various production process control systems as well as holding and distribution and handling customer complaints and more. Sanitation, pest control, employee training and supervision are also covered under cGMPs.
EAS Consulting Group, LLC. assists clients with compliance with the GMP regulations as well as conducting mock FDA audits. Our team of expert GMP regulatory consultants can conduct a thorough facility inspection and provide clients with a summary or necessary improvements and help to develop an action plan for any areas where FDA compliance is lacking. Finally, EAS can provide detailed GMP training to management and staff as required by the regulations.