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CAPA Assessment Report – High-Level Review of FDA 483 Observations

Posted by By Palash Das July 10, 2025Posted inAudit, Drug regulatory and guidelines, News UpdatesNo Comments
Introduction This report presents a high-level assessment of the Form FDA 483 issued to Sun Pharmaceutical Industries Ltd., Halol, dated…
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Growth in BI at Moist Heat Terminal Sterilization

Posted by By Palash Das July 11, 2020Posted inDrug regulatory and guidelines, Steam Sterilizer, Technology1 Comment
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A Review Article on Visual Inspection program for sterile injectable product

Posted by By Palash Das August 10, 2018Posted inDrug regulatory and guidelines17 Comments
A Review Article on Visual Inspection program for sterile injectable product- A complete solution for manual inspection process
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Get copy of 483’s, Non-compliance report and GMP certificate online from Agencies

Posted by By Palash Das August 8, 2018Posted inDrug regulatory and guidelines15 Comments
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Untouched area of Data Integrity in Pharmaceutical Industry

Posted by By Palash Das August 25, 2016Posted inAudit, Drug regulatory and guidelines, News Updates1 Comment
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For Successful Inspection……… (Part I)

Posted by By Palash Das July 12, 2016Posted inAudit, Drug regulatory and guidelines8 Comments
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Reason for Data Integrity in pharma industry

Posted by By Palash Das June 27, 2016Posted inDrug regulatory and guidelines, Interview & Placement, News Updates8 Comments
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Interview Questions for Pharmaceutical industry related jobs (QA,QC,Production,RA,f&d) for B.pharma /M.pharma (Part 10)

Posted by By Palash Das June 18, 2016Posted inDrug regulatory and guidelines, Interview & Placement5 Comments
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Audit readiness in Pharma industry and facing a regulatory audit

Posted by By Palash Das April 26, 2016Posted inDrug regulatory and guidelines
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Interview Questions for Pharmaceutical industry related jobs (QA,QC,Production,RA,f&d) for B.pharma /M.pharma (Part 9)

Posted by By Palash Das March 15, 2016Posted inDrug regulatory and guidelines, Interview & Placement3 Comments
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