In any manufacturing operation involving human manipulation there are hazards which may be created by preoccupation, mental lapse, carelessness and the like. Therefore, all on-the-job and CGMP training should be revisited at frequent intervals and needs to be conducted by qualified individuals. A firm is expected to establish detailed written procedures (training program) outlining the specific areas of the firms operation to be covered. On-the-job training is acceptable, as long as the training is conducted by a qualified individual on a frequent basis. Any employee involved in the manufacturing, filling, processing, handling, holding, or shipping of a medical drug is required to be trained both on-the-job and in the current good manufacturing practices. This would include all delivery and/or truck drivers who deliver medical drug products. The lack of CGMP training is one of the most overlooked areas observed at most medical gas firms. CGMP training should be conducted by qualified
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The FDA requires each firm to establish a quality control unit (QCU). The QCU has the responsibility and authority to approve or reject all drug product containers, closures, in-process materials, labeling, written procedures, the authority to review production records to assure completeness and accuracy, and is responsible for the approval or rejection of all manufactured drug products. The responsibilities and procedures applicable to the QCU must be in writing and must be followed. The designated person(s) are required to meet the Personnel Qualification requirements [211.25], must be identified in the firms procedures, and must receive appropriate quality assurance training. This includes training in the particular operations that the employee performs and in current good manufacturing practice as it relates to the employees functions. A small firm may designate a single individual with the personnel qualifications. QCU managers and personnel can get the training they need fast
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