A system of quality assurance

Quality assurance is a wide-ranging concept that covers all matter

Quality assurance is a wide-ranging concept that covers all matters that individually or collectively influence the quality of an API. It is the total of the organized arrangements made with the objective of ensuring that APIs are of the quality required for their intended use. Quality assurance therefore incorporates GMP, along with other factors that are outside the scope of these guidelines.

A system of quality assurance appropriate for the fabrication, packaging, labelling, testing, distribution, importation, and wholesale of APIs should ensure that:

  1. APIs are designed and developed in a way that takes into account the GMP requirements;
  2. Each fabricator should establish, document, and implement an effective system for managing quality that involves the active participation of management and appropriate manufacturing personnel. Managerial responsibilities should be clearly specified;
  3. Systems, facilities and procedures are adequate and qualified, whether they are new or modified;
  4. Production and control operations are clearly specified;
  5. Analytical methods and critical processes are validated;
  6. Arrangements are made for the supply and use of the correct raw and packaging materials;
  7. All necessary control on APIs and any other in-process monitoring is carried out;
  8. Outsourced activities are subject to appropriate controls and meet GMP requirements;
  9. Fabrication, packaging/labelling, testing, distribution, importation, and wholesaling are performed in accordance with established procedures;
  10. APIs are not released for sale or for further fabrication before the authorized person from the quality control department has approved that each lot has been produced and controlled in accordance with the approved specifications;
  11. Satisfactory arrangements exist for ensuring that the APIs are stored, distributed, and subsequently handled in such a way that quality is maintained throughout their expiry or retest date;
  12. The quality risk management system should ensure that:
    • the evaluation of the risk to quality is based on scientific knowledge, experience with the process and ultimately links to the protection of the patient and
    • the level of effort, formality and documentation of the quality risk management process is commensurate with the level of risk.
  13. The effectiveness, applicability, and continuous improvement of the quality management system is ensured through regular management review and self-inspection;
  14. An annual product quality review of all APIs and intermediates should be conducted with the objective of verifying the consistency of the existing process, and to identify product and process improvements;
  15. All quality related activities should be recorded at the time they are performed.
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