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THE PHARMA REVIEW (JANUARY FEBRUARY 2015)

Quality by Design - A Quality System Approach

Kapil Bhargawa

Introduction: “Quality” of any product in its simplest meaning, is fitness for its intended use. It is thus expected that every pharmaceutical product has established identity, strength, purity, and other quality characteristics designed to ensure the required levels of safety and effectiveness. It is to be free from any contamination and has to be effective. Drug regulatory organizations globally have defined quality of a pharmaceutical product around this meaning only & quality is to be built into the product. When I joined the services of drug regulatory department in India about 40 years ago, there was no concept of GMPs then and one of very farsighted regulator that time itself said that quality should be built into the product and testing alone cannot be relied on to ensure product quality. 

 

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