Tuesday, March 6, 2018

False Calibration and Validation by many Pharma Companies

False Calibration and Validation by many Pharma Companies

Most of the Indian pharma companies in Uttarakhand, Himachal and J& K produce
fabricated calibration and validation data during Audits and in routine .
Condition is horrible in Injectable and Sterile facilities
where fabrication / manipulation in Aseptic Environmental practices , HVAC,water system and Media Fill validation may cause failure of sterility.
Manipulation and falsification
of Microbiological data may leads to serious product failure.
DCGI / CDCSO and state FDA
Must conduct independent
Fair Audits of these facilities and calibration & validation agencies to
Improve GMP condition in Indian Pharma.

Article by : Dr.  Birdi