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Management Responsibility

Quality policy and objectives under MO 169​

Top management of the manufacturing site must establish, document, and communicate a quality policy that is appropriate to the purpose of the organisation and includes commitments to:

  • Compliance with applicable regulatory requirements including MO 169
  • Continual improvement of the QMS effectiveness

Quality objectives must be established at relevant functions and levels, and must be measurable and consistent with the quality policy.

Management representative​

Management must designate a member of management who, irrespective of other responsibilities, has responsibility and authority for:

  • Ensuring that the QMS is established, implemented, and maintained
  • Reporting to top management on the performance of the QMS
  • Promoting awareness of regulatory requirements throughout the organisation

For foreign manufacturers, the management representative must be accessible to PMDA during inspections and throughout the approval process. Communication with PMDA in English The management representative should be able to discuss QMS decisions and technical matters relevant to the inspection. must be possible either directly or through the MAH.

Management review​

Top management must review the QMS at planned intervals. Management review inputs must include:

  • Results of internal audits and supplier audits
  • Customer feedback and complaints
  • Process performance and product conformity data
  • Status of CAPA
  • Changes that could affect the QMS
  • Post-market surveillance data (particularly important for demonstrating MO 169 / GPSP integration)

Management review outputs must include decisions and actions related to improvement, resource needs, and changes to the QMS.

Management review​

Management review records must document decisions and actions, including responsibility assignment and target completion dates. Results of management review must be communicated to relevant personnel, particularly where changes to the QMS are decided. Evidence that top management has reviewed and approved QMS changes is expected by PMDA during inspections.