Regulatory on stability studies for In-vitro diagnostic medical device

  • Sella Senthil M Central Drug Standards Control Organization, DGHS, Ministry of Health and Family Welfare, FDA Bhawan, New Delhi-110002, India
  • Arun Radhakrishnan Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, Tamil Nadu, India
  • Venugopal M Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, Tamil Nadu, India
  • Gowthamarajan Kuppuswamy Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, Tamil Nadu, India

Abstract

The stability of an in-vitro diagnostic (IVD) medical device reagent is the ability to maintain the performance characteristics over a defined time interval. The stability studies are performed to demonstrate that the product remains viable under the specified storage condition until the claimed time period. Since, stability of the IVD cannot be directly assessed through accuracy, performance attributes or customer testing; it is the responsibility of the manufacturer to evaluate the performance of the product by identifying critical factors affecting the stability through developing stability plan, stability protocol and conducting real-time stability studies, accelerated stability studies, in-use stability studies and transport simulated stability studies.

Keywords: Stability, Shelf-life, Performance, Real-time stability, Accelerated Stability

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Published
2019-10-16
Citations
How to Cite
Sella Senthil M, Arun Radhakrishnan, Venugopal M, & Gowthamarajan Kuppuswamy. (2019). Regulatory on stability studies for In-vitro diagnostic medical device. International Journal of Research in Pharmaceutical Sciences, 10(4), 3277-3285. https://doi.org/10.26452/ijrps.v10i4.1633
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Review Articles
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