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.

-Receptionist

• 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

–Escort

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

–Scribe

• 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