FDA inspections in pharmaceutical manufacturing units is being critical these days and it seems that it will be more critical in future because FDA is focusing more on product quality as well as its documentation.
Document fabrication particularly in Indian pharmaceutical companies is a common issue. Therefore, FDA has changed their inspection strategies to sudden inspection without prior notification or very short notification period. At this condition manufacturers have to be always prepared for a FDA inspection.
Before planning a FDA audit everyone should know what FDA inspectors want to find during their inspections. Howard Sklamberg, FDA’s Deputy Commissioner said in FDA Voice, “FDA inspections ensure that when a firm wants to export drugs to the United States, the drugs meet FDA standards and will be of the quality patients and consumers want and deserve.”
FDA also says that they want not only to inspect the product quality but also to enhance the “quality culture” in pharmaceutical manufacturing firms. “Quality culture” explains the vision and demand of FDA inspectors very clearly. FDA wants quality not only in product but also in everything – in product, documents, facility, trainings, behavior, and dresses also. It is easy to manufacture a quality product in a facility having quality in its culture and working. The personnel working in facility should quality conscious and should not compromise with product quality. FDA inspectors also focus on the quality of the equipment and instruments used in facility to understand the quality policies of the manufacturers.
Manufacturers particularly in India must focus to develop a quality culture in manufacturing and quality control of facility. It will help them to face the FDA inspection easily and avoid issuance of form 483s and warning letters particularly in surprise audits.
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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