How Does Japan Handle Non-Compliance Discovered During Drug Quality Audits?

Japan addresses non-compliance in drug quality audits through corrective and preventive actions (CAPA). The Pharmaceuticals and Medical Devices Agency (PMDA) collaborates with manufacturers to rectify issues, ensuring adherence to Good Manufacturing Practices (GMP). Persistent non-compliance may lead to product recalls, suspension of manufacturing licenses, or legal actions to safeguard public health.

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