Good Manufacturing Practices are critical to the safety of CVM regulated products. Those who participate in the Manufacturing, Packaging, Labeling or Holding Operations for these products must follow certain practices to ensure quality.
GMPs are 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. 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 handle customer complaints and more. Sanitation, pest control, employee training, and supervision are also covered under GMPs.
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 of 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.