Checklist for Pharma Inspection Part 08

Data Integrity App

 

11 Do Not Leave the FDA Investigators Unaccompanied: 

Make sure that while the FDA Investigators are in your facility they remain accompanied. This way, the DI can observe and document the actions of the FDA Inspectors, and respond immediately to any concerns.

Additionally, if a company employee remains present at all times, the FDA Investigators will be less inclined to develop or discuss additional “unplanned” inspection “strategies” or “goals” with each other during the course of the inspection.

 

12   Do Not Sign Any Statements or Affidavits:  

At the conclusion of the inspection, the FDA investigators may ask you or your employees to author or sign a statement or affidavit describing the inspection, the observations and/ or the conclusions.

Do not sign, correct or acknowledge any documents, as you have no legal obligation to do so.

 If the inspector presents an affidavit for signature, politely decline to sign and tell the inspector that you must first consult with the FDA lawyer/ consultant

 

13 Exit Interview

The FDA will usually hold an exit interview at the conclusion of the inspection. The escort, Principal Investigator, a representative from Institutional Compliance, and other individuals as appropriate should be notified of the time and place and expect to attend.

The inspector will discuss findings and notify the PI if deficiencies were found. This is an opportunity for the PI to provide information and clarify any questions or concerns raised during the inspection.

 

If serious deficiencies have been found during the inspection, a written Inspectional Observations (Form FDA 483) will be issued, which lists the deficiencies.

 

If no deficiencies are found, or the inspector has comments that s/he believes are not serious enough to warrant a Form FDA 483, no form will be issued.

 

During the exit interview: The Principal Investigator will seek to correct any errors in the findings

1. Both the FDA and Principal Investigator will make sure everything is clear and understood.

2. Observations, comments, and commitments will be noted in the escort inspection notes.

“Trust but Verify “ Ronald Reagan

 

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Data Integrity App

 

Our Data integrity app will helpful for understanding what Data integrity & CSV really means & How 21 CFR Part 11, EU Annex 11 & other regulatory guidelines affects in pharmaceutical Industry.

 

Data Integrity App Include 

- Basic Data Integrity Concepts

- ERES & Its Requirement

- CSV & Its best practices 

- Mock Inspection and General Q&A

- Checklist for inspection

- Inspection Readiness

- Useful SOP’s

- Stay Regulatory Compliant.

 

“Stay One Step Ahead in Pharma IT Compliance” 

Data Integrity App Link:

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Try our "Data Integrity" app which helps you to better understand current regulatory agencies thinking on Data Integrity & CSV.