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Production and Process Controls

Production planning and control​

MO 169 requires production to be planned and carried out under controlled conditions, including:

  • Documented work instructions where absence could affect quality
  • Use of suitable equipment and monitoring/measurement devices
  • Implementation of monitoring and measurement activities
  • Implementation of release, delivery, and post-delivery activities

Process validation​

Processes where the resulting output cannot be fully verified by subsequent inspection and testing must be validated. This includes sterilisation, aseptic processing, welding, and certain adhesive bonding processes. Validation must establish:

  • Defined criteria for review and approval
  • Equipment qualification (IQ/OQ/PQ)
  • Methods and procedures
  • Requirements for re-validation

Environmental controls​

For devices requiring controlled manufacturing environments (cleanrooms, controlled humidity), environmental monitoring must be established and records maintained. Environmental monitoring data is reviewed during PMDA QMS inspections.

Sterilisation process controls​

For sterile devices, sterilisation is a validated special process. The sterilisation cycle must be validated against the recognised sterilisation standard, and every production batch must be traceable to sterilisation cycle records. Sterilisation validation records are reviewed in detail by PMDA during inspections.

Process validation​

​Change control and re-validation

MO 169 requires that changes to validated processes, equipment, or environmental conditions be controlled through a documented change management system. Changes must be evaluated for impact on product quality and may require re-validation. PMDA inspectors review change control records to assess how the manufacturer manages process modifications and determines re-validation scope.