Data Integrity (Part-III) (Some Major Observations) Posted by By Palash Das December 23, 2015Posted inDrug regulatory and guidelines, QMS, Quality Assurance
Data Integrity Part-II (Laboratory) Posted by By Palash Das December 22, 2015Posted inDrug regulatory and guidelines, QMS, Quality Assurance
Data Integrity -Part-I Posted by By Palash Das December 22, 2015Posted inDrug regulatory and guidelines, QMS
Regulatory expectation and guidance on Pharmaceutical market complaints Posted by By Palash Das October 29, 2015Posted inDrug regulatory and guidelines
When the FDA Inspector visits your firm, What are the Chances of a Really Bad Outcome? Posted by By Palash Das May 24, 2015Posted inDrug regulatory and guidelines
Major USFDA warning Letters observation from 2000 Posted by By Palash Das February 5, 2015Posted inDrug regulatory and guidelines, News Updates
Selection of Glass Vial Sterile Injectable product Posted by By Palash Das March 21, 2014Posted inDrug regulatory and guidelines, News Updates
Guidance to Qualification and Validation towards Global Pharmaceutical Practice Posted by By Palash Das November 7, 2013Posted inDrug regulatory and guidelines, Quality Assurance, Validation
CFR – Code of Federal Regulations Title 21 Posted by By Palash Das August 17, 2013Posted inDrug regulatory and guidelines, Quality Assurance
Guidelines for viable & non -viable counts in gmp areas (As per WHO,2011) Posted by By Palash Das April 24, 2013Posted inDrug regulatory and guidelines, News Updates, Quality Assurance, Validation