Info

Note: Bulk Spirulina product specifications: Carotenoids >370 mg/100 g. Source: Data from Earthrise.

Note: Bulk Spirulina product specifications: Carotenoids >370 mg/100 g. Source: Data from Earthrise.

good manufacturing practices (cGMPs) promulgated under the United States Federal Food, Drug, and Cosmetic Act and applicable state statutes and regulations. These laws assure that the facilities, methods, practices, and controls used in the manufacture, processing, packing, or holding of food products are in conformance with or are operated in conformity with good manufacturing practices (GMPs) to assure that the food products are safe for consumption and have been prepared, packed, and held under sanitary conditions.

All operations in receiving, inspecting, transporting, packaging, segregating, preparing, processing, and storing of the product are conducted in accord with adequate sanitation principles. Raw materials and ingredients are inspected and segregated as necessary to assure that they are clean, wholesome, and fit for processing and are stored under conditions that will protect against contamination and minimize deterioration. Packaging materials do not transmit contaminants or objectionable substances to the product, and provide adequate protection from contamination.

The quality assurance director (QCD) has the responsibility and authority to approve or reject all raw materials, in-process materials, packaging materials, and final product and labeling, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. The QAD has the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the final product. Adequate laboratory facilities for the testing and approval (or rejection)

of raw materials, in-process materials, packaging materials, and final product are available to the QAD. The manufacturing facility is also audited and inspected for violations of GMP on a regular basis by the Quality Systems Manager (QSM). Spirulina facilities in the United States are subjected to periodic unannounced inspections from federal, state, and local regulatory agencies. Audits are also conducted by third-party registrars as part of an ISO 9001:2000 or equivalent programs. External laboratories are used to standardize methods and for independent verification of analytical results.

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