FDA Focus on “Quality Culture” in Pharmaceuticals


FDA Focus on “Quality Culture” in Pharmaceuticals Manufacturing Firms 

  • FDA inspection will be more critical for Indian Pharmaceutical Companies
  • Document Fabrication is a common issue in Indian Pharmaceutical firms

FDA (Food Drug Authority) inspection in pharmaceuticals units being critical these days because FDA not inspect product quality it also enhance the “Quality Culture”.

FDA inspectors observed common issue of document fabrication in Indian pharmaceuticals firms. Due to this reason FDA has changed their strategies of inspection. FDA can inspect manufacturing firms without prior information or very short notice period.

Due to this condition Pharmaceutical manufacturers have to always create “Quality Culture”.

“Quality Culture” is a vision and demand of FDA which explains that Quality not only in product but also in everything (eg. Product, Document, Behavior, Facility, Dresses). According to FDA if manufacture having quality in its culture and working then it is easy to manufacture a quality product.

FDA’s Deputy Commissioner Howard Sklamberg said, “FDA inspection ensure that when a firm wants to export drug to the United States the drug meet FDA standers and will be of the quality patients and consumers want and deserve.

So if any manufacture firm planned FDA inspection they should stress about quality conscious personnel and also facility, equipment and instrument quality. it will help them to face FDA audit.