| The quality control department shall have the | | | | identity, strength, quality, and purity of the drug |
| responsibility and authority to approve or reject all | | | | product. The responsibilities and procedures |
| components, drug product containers, closures, | | | | applicable to the quality control department shall |
| in-process materials, packaging material, labeling, | | | | be in written form such written procedures shall |
| and drug products. They will review production | | | | be followed. |
| records to assure that no errors have occurred | | | | Each person engaged in the quality control |
| or, if errors have occurred, that they have been | | | | department shall have education, training, and |
| fully investigated. The quality control department | | | | experience, or any combination thereof, to enable |
| shall be responsible for approving or rejecting drug | | | | that person to perform the assigned functions. |
| products manufactured, processed, packed, or | | | | Training shall be in the particular operations that |
| held under contract by another company. | | | | the employee performs and in current good |
| Adequate laboratory facilities for the testing and | | | | manufacturing practice. Training in current good |
| approval (or rejection) of components, drug | | | | manufacturing practice shall be conducted by |
| product containers, closures, packaging materials, | | | | qualified individuals on a continuing basis and with |
| in-process materials, and drug products shall be | | | | sufficient frequency to assure that all employees |
| available to the quality control department. The | | | | remain familiar with CGMP requirements applicable |
| quality control department shall have the | | | | to them. There shall be an adequate number of |
| responsibility for approving or rejecting all | | | | qualified personnel to perform and supervise all |
| procedures or specifications impacting on the | | | | operation in quality control department. |