As posted in the Eudra GMDP database, the Italian Medicines Agency found Sri Krishna Pharmaβs Hyderabad, India plant to be in non-compliance with GMPs in mid-December, following an inspection earlier in the month. The facility was cited for: β lot rejection and using βtrialβ samples β lab controls β missing or poor quality agreement, and β torn and discarded batch records. In late December, the French National Agency for Medicines and Health Products Safety found Medreich Limitedβs Andra Pradesh, India plant to be in non-compliance after an inspection in early 2013. The plant was cited for: β data falsification β quality management β personnel qualification β equipment maintenance β documentation, and β production issues.
[/membership][membership level=”0,4″][The content continues for paid members only.]
Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership]