The Quality Control Department of Pharmaceutical Unit

The quality control department 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. They will review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. The quality control department shall be responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company.

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 department. The quality control department shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product. The responsibilities and procedures applicable to the quality control department shall be in written form such written procedures shall be followed.

Each person engaged in the quality control department 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. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that all employees remain familiar with CGMP requirements applicable to them. There shall be an adequate number of qualified personnel to perform and supervise all operation in quality control department.

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