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Title: :  Implementation of Qbd & AQbD approach in pharmaceutical formulation and analytical method development: A Comprehensive Research-Review
PaperId: :  18342
Published in:   International Journal Of Advance Research And Innovative Ideas In Education
Publisher:   IJARIIE
e-ISSN:   2395-4396
Volume/Issue:    Volume 8 Issue 5 2022
DUI:    16.0415/IJARIIE-18342
Licence: :   IJARIIE is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.

Author NameAuthor Institute
Rukaiya ShirohiwalaSigma Institute of Pharmacy, Vadodara
Dr. Chainesh ShahSigma Institute of Pharmacy, Vadodara
Dr. Umesh UpadhyaySigma Institute of Pharmacy, Vadodara

Abstract

Pharmaceutical Quality by Design(QbD)
Quality by Design (QbD), Quality Target Product Profile (QTPP), Critical Quality Attributes (CQA), Process Analytical Technology (PAT), Analytical Quality by Design (AQbD)
In pharmaceutical terms, quality means a product free from any contamination and delivers the intended therapeutic benefit. The pharmaceutical sector is always seeking for new ways to guarantee and improve the product's efficacy, quality, and safety. Contrary to what recent medicine recalls, manufacturing failure costs, scale-up challenges, and regulatory burdens would imply, along with little knowledge of the process and important process parameters, the traditional Quality by Testing (QbT) strategy mostly relies on end-product testing to verify product quality and performance. QbD (Quality by design) is one of the in-process design experiments approved by the FDA to maintain the quality of the drug products before reaching into the market. QbD makes cost-efficiency and an easy production procedure a reality in the pharmaceutical business. QbD is a methodical, risk-based, proactive strategy to drug development that starts with predetermined goals and stresses product and process understanding as well as process control grounded on reliable research and high-quality risk management. QbD has its perspectives to contribute the drug design, development, and manufacture of high-quality drug products in the modern era of pharmaceuticals. The main aim of this review article to showcase a detail overview on QbD along with its elements (QTPP, CQA, CPP, CMA, Design space, control strategy and continuous implementation), tools (risk assessments, DoE and PAT), process of implementation (FDA and ICH guidelines), QbD role in different continents, opportunities in implementing QbD, future prospects of QbD and other features like Quality Risk Management, Pharmaceutical Quality System and Process Analytical Technology (PAT) guidelines are also being now introduced and involved into analytical method development processes. They are accepted as AQbD (Analytical Quality by Design) concepts by the industry.

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IJARIIE Rukaiya Shirohiwala, Dr. Chainesh Shah, and Dr. Umesh Upadhyay. "Implementation of Qbd & AQbD approach in pharmaceutical formulation and analytical method development: A Comprehensive Research-Review" International Journal Of Advance Research And Innovative Ideas In Education Volume 8 Issue 5 2022 Page 1129-1160
MLA Rukaiya Shirohiwala, Dr. Chainesh Shah, and Dr. Umesh Upadhyay. "Implementation of Qbd & AQbD approach in pharmaceutical formulation and analytical method development: A Comprehensive Research-Review." International Journal Of Advance Research And Innovative Ideas In Education 8.5(2022) : 1129-1160.
APA Rukaiya Shirohiwala, Dr. Chainesh Shah, & Dr. Umesh Upadhyay. (2022). Implementation of Qbd & AQbD approach in pharmaceutical formulation and analytical method development: A Comprehensive Research-Review. International Journal Of Advance Research And Innovative Ideas In Education, 8(5), 1129-1160.
Chicago Rukaiya Shirohiwala, Dr. Chainesh Shah, and Dr. Umesh Upadhyay. "Implementation of Qbd & AQbD approach in pharmaceutical formulation and analytical method development: A Comprehensive Research-Review." International Journal Of Advance Research And Innovative Ideas In Education 8, no. 5 (2022) : 1129-1160.
Oxford Rukaiya Shirohiwala, Dr. Chainesh Shah, and Dr. Umesh Upadhyay. 'Implementation of Qbd & AQbD approach in pharmaceutical formulation and analytical method development: A Comprehensive Research-Review', International Journal Of Advance Research And Innovative Ideas In Education, vol. 8, no. 5, 2022, p. 1129-1160. Available from IJARIIE, https://ijariie.com/AdminUploadPdf/Implementation_of_Qbd___AQbD_approach_in_pharmaceutical_formulation_and_analytical_method_development__A_Comprehensive_Research_Review_ijariie18342.pdf (Accessed : 06 October 2024).
Harvard Rukaiya Shirohiwala, Dr. Chainesh Shah, and Dr. Umesh Upadhyay. (2022) 'Implementation of Qbd & AQbD approach in pharmaceutical formulation and analytical method development: A Comprehensive Research-Review', International Journal Of Advance Research And Innovative Ideas In Education, 8(5), pp. 1129-1160IJARIIE [Online]. Available at: https://ijariie.com/AdminUploadPdf/Implementation_of_Qbd___AQbD_approach_in_pharmaceutical_formulation_and_analytical_method_development__A_Comprehensive_Research_Review_ijariie18342.pdf (Accessed : 06 October 2024)
IEEE Rukaiya Shirohiwala, Dr. Chainesh Shah, and Dr. Umesh Upadhyay, "Implementation of Qbd & AQbD approach in pharmaceutical formulation and analytical method development: A Comprehensive Research-Review," International Journal Of Advance Research And Innovative Ideas In Education, vol. 8, no. 5, pp. 1129-1160, Sep-Oct 2022. [Online]. Available: https://ijariie.com/AdminUploadPdf/Implementation_of_Qbd___AQbD_approach_in_pharmaceutical_formulation_and_analytical_method_development__A_Comprehensive_Research_Review_ijariie18342.pdf [Accessed : 06 October 2024].
Turabian Rukaiya Shirohiwala, Dr. Chainesh Shah, and Dr. Umesh Upadhyay. "Implementation of Qbd & AQbD approach in pharmaceutical formulation and analytical method development: A Comprehensive Research-Review." International Journal Of Advance Research And Innovative Ideas In Education [Online]. volume 8 number 5 (06 October 2024).
Vancouver Rukaiya Shirohiwala, Dr. Chainesh Shah, and Dr. Umesh Upadhyay. Implementation of Qbd & AQbD approach in pharmaceutical formulation and analytical method development: A Comprehensive Research-Review. International Journal Of Advance Research And Innovative Ideas In Education [Internet]. 2022 [Cited : 06 October 2024]; 8(5) : 1129-1160. Available from: https://ijariie.com/AdminUploadPdf/Implementation_of_Qbd___AQbD_approach_in_pharmaceutical_formulation_and_analytical_method_development__A_Comprehensive_Research_Review_ijariie18342.pdf
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