Good Manufacturing Process
Warehouse • All incoming raw materials go through an identification test (FT-IR) before their use. • Personnel pulls the raw materials needed to produce this certain batch. Only raw material that has been QC Released (after Identification tests) is used. • Quality Control checks the proper raw material and information related to this particular batch. After QC verification, raw materials are released to be weighed. Weighing • Weighing of the raw material according to the batch record’s specified weights. • A second verification is made to ensure the proper weights have been weighed for this particular order. Blending • The verified raw materials are then blended for 20 minutes. • Quality Control checks the mixed batch to ensure proper mixing has been achieved. After QC verification, blend is released to be encapsulated. Capsuling • The blend then becomes encapsulated, hitting the preferred weight(s). • Quality Control spot checks to verify capsule weights. • Quality Control inspects the capsules for proper weight, cleanliness of the capsules, and capsule count. After QC verification, capsules are released to be packaged. Packaging • Before packaging, Quality Control verifies all components that are needed for said batch. The production line is checked for cleanliness as well to verify there are no other signs from the previous batch (Line Clearance). • After QC verification, packaging begins. • QC spot checks throughout packaging. Final Product Testing • A sample of the finished product is sent to a 3rd party lab for microbial testing. Quality Release • Quality Control inspects final product. • After QC verifies the final product and receives all passing test results, QC releases batch for shipment. --- Another Way of Saying the Above Information --- MANUFACTURING PROCESS Raw materials received for the capsules are placed in quarantine until identification tests are completed. If the material is equivalent to accepted industry standards, Quality Control will release the material and assign it a lot number. Upon release, the raw materials will be weighed out as specified in the formula. Each weighing is double checked for accuracy. The active ingredients are blended together geometrically by weight to assure homogeneity. Fillers are then added to the active ingredient blend. Each ingredient is double checked for accuracy as it is added to the blender. The matrix of these compounds is then blended to a uniform and consistent product. The matrix is then filled into the capsules. Weight specifications are followed as specified in the formula. A color match with a sample fill standard of the capsules is verified by Quality Control to assure batch to batch consistency. Quality Control tests the capsules every half hour during the run. This assures that the finished capsule meets the formula specification for weight. The capsules are then cleaned to remove any fill material that may adhere to the outside of the capsule. Samples are then submitted to Quality Control for laboratory tests. Quality Control then performs identification checks. The finished product is then released after the laboratory tests are approved