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International Journal of Veterinary Sciences and Animal Husbandry
Vol. 3, Issue 5, Part A (2018)

Adaptation of quality by design concept for the development & manufacturing of the new castle disease virus antibody detection test kit

Author(s): Hardik Mistry, Dr. Upendra Jani, Tejas Patel and Nupur Dave
Abstract: QbD (Quality by Design) is the recent systematic, scientific, risk-based, holistic, proactive approach & regulatory requirement for designing and developing the product and the manufacturing process to achieve the predefined product quality objectives and to reduce rejection or reprocessing of the batch, with increased cost and regulatory burden.
New Castle Disease is one of the most common causing factors which can affect the high demand of the poultry eggs and meats. Although vaccines are commercially available to have protection against the New Castle Disease infection in poultry, there is need for the sero monitoring and quick detection of the developed antibody in the poultry.
QbD concept is to be adopted for the development and manufacturing of the New Castle Disease (NDV) antibody detection test kit to have the detection kit with identified and required target profile. The results of the adaptation is to be evaluated on the products manufactured after the QbD concept is built into process of development and manufacturing of the NDV antibody detection.
Pages: 43-49  |  442 Views  17 Downloads
How to cite this article:
Hardik Mistry, Dr. Upendra Jani, Tejas Patel, Nupur Dave. Adaptation of quality by design concept for the development & manufacturing of the new castle disease virus antibody detection test kit. Int J Vet Sci Anim Husbandry 2018;3(5):43-49.
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International Journal of Veterinary Sciences and Animal Husbandry