Tuesday , 13 April 2021

Common Deficiencies in Regulatory Submissions

CH. Vasavi1*, D. Priyadharsini2, Dr. K. Harinadha Baba3, N. Uma4
1,4Sri Sivani College of pharmacy, JNTUK, Kakinada
2Asst. Professor, Sri sivani College of Pharmacy, JNTUK, Kakinada
3Principal Sri sivani College of pharmacy, JNTUK, Kakinada

This concludes our discussion on the commonly cited deficiencies for control of the drug product and stability. This is by far the most active area when it comes to deficiencies and comments cited to ANDA applicants. The prevalence of deficiencies speaks to the criticality of the information with respect to controls proposed for routine release and stability analysis of the drug product. Applicants should endeavor to provide sound scientific and regulatory justification for all specifications (tests, methods, and criteria) that are proposed.As stated in the beginning of the paper, this is not an exhaustive list of deficiencies in the drug product release and stability sections. However, the authors have attempted to provide the underlying reasons for common deficiencies related to the control of the drug product during release and stability testing. Our goal is to shed light on the rationale for citing these deficiencies and demonstrating how pharmaceutical development studies, performed during the initial development of the product, may reduce the instances of these deficiencies being cited.
Keywords: FDA, Common deficiencies.

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