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 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 procedures, required documents, and records that must be developed and maintained to minimally comply with the regulation. 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.
We assist firms with the development and implementation of Quality Systems necessary to comply with 21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. This includes the establishment of raw material, packaging component, in-process material, and finished product Specifications to ensure that the quality of the finished dietary supplement meets the requirements for identity, purity, strength, composition, and limits of potential contaminants; the preparation of thorough and detailed Master Manufacturing Records that will be used for the consistent manufacture, packaging, and labeling of each batch of product documented in the Batch Production Record; and the design of an organized, cohesive Quality Incident System to address quality issues such as Out of Specification results, Deviations, Returned Dietary Supplements, Consumer Product Complaints, and other quality issues that may result in Non-Conforming Products that require a Material Review and needed Corrective and Preventative Actions. Given our extensive experience, EAS can also assist with ensuring that contract manufacturing/packaging/testing and distribution partners are fully GMP compliant through the preparation of a Quality Agreement and supplier qualification program that includes on-site audits of partner facilities by experienced EAS auditors.