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Contracted QMS Operations

What can be outsourced under MO 169​

Under MO 169, many manufacturing and quality activities can be outsourced to third parties — known as "contract manufacturers" or "outsourced process providers." Activities commonly outsourced include:

  • Manufacturing operations (component fabrication, assembly)
  • Sterilisation
  • Testing laboratories (biocompatibility, electrical safety, etc.)
  • Packaging and labelling operations
  • QMS documentation services

MAH's oversight obligations​

When the MAH contracts manufacturing or quality activities to third parties, the MAH does not transfer its regulatory responsibility. The MAH remains responsible for the quality of all contracted operations and must:

  1. Evaluate and qualify contracted parties before engaging them
  2. Define responsibilities in a written contract or quality agreement
  3. Conduct periodic audits of contracted parties to verify continued compliance with MO 169 and the contract terms
  4. Maintain records of audit findings and actions taken

PMDA will review the MAH's supplier qualification and oversight records during QMS inspections.

Sterilisation as a contracted process​

If sterilisation is outsourced to a contract steriliser, special attention is required:

  • The contract steriliser must hold the appropriate manufacturing registration
  • The sterilisation process validation must cover the specific device(s) being processed
  • Change notification requirements must be covered in the contract (changes to sterilisation cycle parameters may require Ichibu Henko)

Supplier Qualification Requirements: A contract manufacturer or outsourced provider must be qualified by the MAH before engaging in manufacturing or quality operations. Qualification typically includes: review of the supplier's QMS documentation, on-site audit by the MAH or a third party, verification of certifications (ISO 13485 or equivalent), and documented assessment of the supplier's capability to meet specifications. All qualification records must be maintained and made available during PMDA inspections.