Quality Assurance

To establish the quality system:
Establish the quality management system to describe how the firm follows CGMPs and operates to maintain a state of control. Keep the quality management system current with good industry practices, and applicable to the mission of your operation.

To establish procedures and specifications:
Ensure that the procedures and specifications of firm are appropriate and followed, i.e., maintain control and take responsibility.

To establish manufacturing controls:
Ensure that appropriate manufacturing in-process controls are implemented and are performed during manufacturing operations and results are satisfactory.

To review and approve or reject things:
Review and approve/reject/change in any document that gives work instructions and set requirements such as procedures, protocols, test methods, and specifications, reprocessing and rework procedures and production batch records and make the final decision to release a product.

To ensure investigation of nonconformance:
Ensure investigation is conducted and root cause is eliminated for production and control record errors, discrepancies, and failure to meet specification, including quality attributes.

To keep management informed:
Report on product, process and system risks, report on outcome of regulatory inspections and ensure responses are complete and managed to verifiable closure—and keep management informed.

To describe responsibilities in writing:
Have a complete and compliant procedure that describes responsibilities for the specified person with respect to the department and to ensure that the procedure is being implemented.

To audit compliance to the quality system:
Audit for compliance to policies and procedures: on paper vs. practice. Report quality system performance metrics, including trends, that help decision-making and taking proactive targeted actions

To remain independent:
Ensure there is no conflict of interest between regulatory responsibilities and actual daily activities. Be independent reviewer and approver with respect to manufacturing and process/product development units.