WJPPS Citation

Login

Search

News & Updation

  • Updated Version
  • WJPPS introducing updated version of OSTS (online submission and tracking system), which have dedicated control panel for both author and reviewer. Using this control panel author can submit manuscript
  • Call for Paper
    • WJPPS  Invited to submit your valuable manuscripts for Coming Issue.
  • Journal web site support Internet Explorer, Google Chrome, Mozilla Firefox, Opera, Saffari for easy download of article without any trouble.
  •  
  • New Impact Factor
  • WJPPS Impact Factor has been Increased to 8.025 for Year 2024.

  • WJPPS: MARCH ISSUE PUBLISHED
  • March Issue has been successfully launched on 1 March 2024.

  • ICV
  • WJPPS Rank with Index Copernicus Value 84.65 due to high reputation at International Level

  • Scope Indexed
  • WJPPS is indexed in Scope Database based on the recommendation of the Content Selection Committee (CSC).

Abstract

QUALITY BY DESIGN APPROACH FOR ANALYTICAL METHOD DEVELOPMENT

Sakshi Sharma* and Dr. Sharad Wakode

ABSTRACT

An application of the Quality by Design (QbD) approach, is to the exemplar of analytical method development, the process commonly referred to as AQbD. The benefits of applying AQbD principle is to identifying and minimizing sources of variability that might lead to poor method robustness and ensuring that the method meets its planned performance requirements throughout the product lifecycle. It allows the analytical method for movement within method operable design region (MODR). The variables which affect the output and subjected to through risk assessment factor are optimized. The final step is to validated and a control strategies. Analytical method developed using AQbD approaches to reduces out‐of‐trend (OOT) and out‐of‐specification (OOS) which results into the robustness of the method within the region Continuous improvement is the key to the success of AQbD. Harmonization of QbD terms and specific guidelines on implementation of the QbD approach in all fields of product development is require to design the path towards embracing this unique and effective approach . Owing to the famine of overviews on this topic, this paper endeavor to explicate the AQbD process and also to correlate with product quality by design and pharmaceutical analytical technology(PAT).

Keywords: QbD, AQbD, Analytical, MODR, Quality by Design.


[Download Article]     [Download Certifiate]

Call for Paper

World Journal of Pharmacy and Pharmaceutical Sciences (WJPPS)
Read More

Online Submission

World Journal of Pharmacy and Pharmaceutical Sciences (WJPPS)
Read More

Email & SMS Alert

World Journal of Pharmacy and Pharmaceutical Sciences (WJPPS)
Read More