Analytical Quality by Design in Stress Testing or Stability - Indicating Method

• Published in: Asian Journal of Pharmaceutical Analysis Vol. 11; no. 2; pp. 170 - 178
• Main Authors: Vyas, Amitkumar J., Visana, Nilam M., Patel, Ajay I., Patel, Ashok B., Patel, Nilesh K., Shah, Sunny R.
• Format: Journal Article
• Language: English
• Published: Raipur Athena Information Solutions Pvt. Ltd 01.06.2021
• Subjects: 21st century; Chromatography; Drug dosages; Manufacturing; Methods; Pharmaceutical industry; Pharmaceuticals; Pharmacy; Principles; Process controls; Product development; Product life cycle; Quality control; Reproducibility; Variables; United States > US; India
• DOI: 10.52711/2231-5675.2021.00029
• ISSN: 2231-5667

Analytical methods are required to be developed at different stages of the pharmaceutical product life cycle. The concept of QbD can be extended to analytical method development known as analytical quality by design (AQbD). Quality by design is a systematic approach to development that begins with predefined objects and emphasizes product and process understanding and helps in the systematic approach to drug development. The concepts described in ICH Q8- Q11, commonly referred to as quality by design (QbD), have also been applied to the development of analytical methods. The benefits of applying the QbD principle to analytical methods include identifying and minimizing sources of variability that may lead to poor method robustness and ensuring that the method meets its intended performance requirements throughout the product and method lifecycle. Stress testing is a very important tool in pharmaceutical research and development to predict long-term stability. Stress studies should be performed in stability-indicating method development to understand drug behavior but also can be performed with method validation for regulatory filling predict stability and measure impurities. For determination of degradation pathways and structural elucidation of degradation produced, these stress testing are helpful. It is also used to select the storage condition and improve the manufacturing process of formulations.