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