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Computer and Packaging

In: Computers and Technology

Submitted By LauraGalway
Words 7937
Pages 32
CFR - Code of Federal Regulations Title 21 PART 211 | CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS | Subpart B--Organization and Personnel | Sec. 211.22 Responsibilities of quality control unit. | (a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, 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 quality control unit shall be responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company.(b) Adequate laboratory facilities for the testing and approval (or rejection) of components, drug product containers, closures, packaging materials, in-process materials, and drug products shall be available to the quality control unit.(c) The quality control unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product.(d) The responsibilities and procedures applicable to the quality control unit shall be in writing; such written procedures shall be followed. | | Sec. 211.25 Personnel qualifications. | (a) Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate

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