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 manufacture, packaging, labeling or holding of dietary supplements to follow certain practices to ensure quality.
GMPs are by definition a system of procedures and documentation, written or analytical, to ensure the product produced has the identity, strength, quality, and purity which it purports or is represented to possess. In 21 CFR 111 there are a number of written procedures, required documents, and records that must be developed and maintained to minimally comply with the regulation. The vast experience of our EAS consultants will help you to not only comply with these requirements but also develop a strong quality system that is also practical and efficient.
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.