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THE PHARMA REVIEW (SEPTEMBER - OCTOBER 2015)

My Perspective for Pharmaceutical Manufacturing Technologies / Processes and Continuous Improvements

Girish Malhotra

Introduction: Regulations are necessary for quality assurance of drugs. FDA established 21CFR314.701,2 and it is a very important rule. It assures that there is no “by manufacturer’s choice” deviation from the manufacturing methods and practices that have been filed for the components involved in the manufacture of any salable drug – the active pharmaceutical ingredient (API) and their formulation – and labeling, packaging etc. Every change has to be reported. Drastic process changes are discouraged.

 

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