Gu­jarat to set up rapid mi­cro­bio test­ing lab

BioSpectrum (India) - - POLICY AND REGULATORY NEWS -

Gu­jarat Food and Drug Con­trol Ad­min­is­tra­tion (FDCA) is all set to cre­ate a bench­mark in terms of test­ing and analysis of con­tam­i­na­tion of phar­ma­ceu­ti­cal prod­ucts through set­ting up of Asia’s first gov­ern­ment rapid mi­cro­bi­o­log­i­cal test­ing lab. The lab which is now be­ing val­i­dated and cal­i­brated is sched­uled to be­come op­er­a­tional soon to check con­tam­i­na­tion in medicines im­ported and ex­ported as per global reg­u­la­tory re­quire­ments. Drug reg­u­la­tors are also be­ing equipped on ar­eas of data In­tegrity to meet FDA ex­pec­ta­tions and how to en­sure a ro­bust qual­ity con­trol (QC) sys­tem. Mean­while, Gu­jarat FDCA and US FDA have also col­lab­o­rated for train­ing the drug con­trol of­fi­cials in Gu­jarat on par with the US FDA in­spec­tors to au­dit phar­ma­ceu­ti­cal fa­cil­i­ties. In line with this de­vel­op­ment, Gu­jarat Med­i­cal Ser­vices Cor­po­ra­tion Lim­ited (GMSCL) has col­lab­o­rated with BioMérieux. An MoU has also been signed with Gu­jarat FDCA as part of the strate­gic partnership to usher in knowl­edge shar­ing on mi­cro­bi­o­log­i­cal test­ing tech­nolo­gies for the phar­ma­ceu­ti­cal sec­tor.

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