Inspection readiness

Quality Assurance
1

Dear All

I am preparing a SOP on Inspection readiness procedure (Europe). Could you please advice me on this? Much appreciated.

Thank you

2

In fact there should not be any preparation for readiness of regulatory inspection. We should be ready all the time for any inspection or audit.
Only administrative aspects should be ensured. Technically, you should ensure that all completed batches related documents are properly archived as per internal SOP. There should not be any pending matter of completed batches except for on-going investigations of non-conformances, market complaints etc.

The administrative arrangements should include but not limited to the following,

  • Readiness of conference / meeting room for inspectors / Auditors to sit and work
  • Good cnnectivity of WiFi and internet system (IT related issues)
  • Availability of photocopying machine (Dedicated for inspection work)
  • Lists of SOPs (for all departments) and all current SOPs, Manuals (Quality Manual, Site Master File, Validation Master Plan, Master Calibration schedules, Preventive Maintenance schedules, Facilty layouts / drawings, Utility drawings, Disaster Recovery plan etc.)
  • Company presentation slides
  • Training to the employees on how to face inspection / audit (Do’s and Don’ts)
  • CAPA status of previous inspection observations
  • Arrangement of tea, coffee, snacks and meals for inspectors (training to the canteen / cafeteria staff about serving food to the inspectors with proper gowning and mannerism)
  • List of responsible persons who will accompany inspector during inspection (QA person is a must through out the inspection) and in the conference / meeting room
  • Lis to back up office persons who will collect and handover the requested documents, SOPs, reports, and other records to the responsible QA or other persons accompaning the inspectors.
  • List of persons who will be present for opening meeting and close out / warp up meeting with the inspectors
  • Vehicle arrangments for the inspectors (Logistics- Travelling, Stay in the hotel and pick up from the air port or hotel to the facility and return)

Based on the above aspects an internal SOP should be prepared.

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