Saturday, February 21, 2009

FDA inspection - Effective SOP for participants duty

Following are key points need to be followed to have a successful FDA inspection.

following people play major role in FDA inspections and hence the roles and responsibilities must be defined well and informed.


  • Maintains a Current Inspection Contact List
  • Actively in Contacting Key Personnel
  • Trained on FDA Inspection SOP
  • Does notReview - FDA credentials, Accept FDA 482, Leave FDA Investigators Unattended, Keep FDA Investigators Waiting

–Inspection Coordinator

  • Responsible for Managing the FDA Inspection
  • First Person to be Notified upon FDA arrival
  • Appoints other members of the Inspection Team
  • Actively involved in all Topics
  • Calls Time Outs-when needed
  • Should be Escort for Lead FDA Investigator
  • Be Present at all Times


  • One per FDA Investigator
  • With Assigned FDA personnel At All Times
  • Broad Knowledge
  • Answers Questions Appropriately
  • Refers to the Inspection Coordinator


  • One Scribe per FDA Investigator
  • Accuracy in Note Taking -Questions, Responses ,Documents Requested/Received
  • With Assigned FDA personnel At All Times
  • Generally a Non-Speaking Role
  • Must be Knowledgeable to Understand Discussion
  • Will Transcribe Notes Daily-Record of Inspection

–Document Support

  • Final QA Check on ALL Documentation
  • Maintains a Complete Record of All Docs Sent to FDAOrganizes and Stages Documents
  • Coordinates Runners
  • Makes Copies of Documents for FDA
  • Stamps Copies- “Confidential” or “Proprietary Information

–Subject Matter Expert

  • Expert Knowledge of Specific Areas of Operation’“On Call”
  • Articulate and Knowledgeable
  • Knows when to speak and when not to speak
  • Redirects Questions to the Inspection Coordinator

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