Preparing For Pharmaceutical Inspections

 

Data Integrity App

Will you know when FDA is coming?  It depends upon Pre-approval and routine inspections typically are announced five calendar days in advance.

Compliance follow-up inspections and “for cause” inspections are not pre-announced. FDA inspection of a foreign establishment typically is preannounced two to three months in advance to allow time for travel and scheduling logistics.

FDA investigators are very competent.

Several factors should be considered selection of SME(Subject Matter Experts):

Competency in answering an investigator’s questions.

Performance under stress

Adaptability

Data Integrity App

Know Inspectors

Research the background of the auditor(s) to gain knowledge of their experience and areas of expertise.

•Use available resources:

•Existing Industry contacts

•Internet Searches

•Social Media profile (LinkedIn, Facebook etc)

 

 Server room Controls:

•The room is secure.

•IT access only.

•Tidy and in good working order.

•Has back-up and disaster recovery procedures in place.

•Date/time functionality of servers are correct.

 

Training of SME:

SME trained on below kind of questioners to face inspections. 

Close-ended questions

Open-ended questions

Leading questions

Nondirective or neutral questions

Assumptive questions

Restatement of questions

 

Verify below things

- This was a working day

- There is documented evidence that analyst & reviewer were working that day

- Analyst was trained to perform analysis

- Reviewer was authorized to review

-Instrument logbook shows instrument was available that day & time

- Instrument was within calibration

- Instrument printout confirms date, time, value & instrument ID

- Instrument printout is initialed by analyst across printout & laboratory record page

- Color of printer ink is same as other printouts from that day

- Sample logbook in laboratory details sample ID

-  Sample logbook in plant details sample ID

- Sample collection time is before sample analysis time

- Signatures & initials on records conform to the master signatures list

“Trust but Verify “ Ronald Reagan

 

Across the internet, there are millions of resources are available which provide information about Everything.

 

If you found all content under one roof then it will save your time, effort & you will more concentrated on your important activity.

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:

https://play.google.com/store/apps/details?id=com.innovativeapps.dataintegrity

 

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