Analytical Quality by Design Approach to Test Method Development and Validation in Drug Substance Manufacturing
Joint Authors
Raman, N. V. V. S. S.
Mallu, Useni Reddy
Bapatu, Hanimi Reddy
Source
Issue
Vol. 2015, Issue 2015 (31 Dec. 2015), pp.1-8, 8 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2015-01-26
Country of Publication
Egypt
No. of Pages
8
Main Subjects
Abstract EN
Pharmaceutical industry has been emerging rapidly for the last decade by focusing on product Quality, Safety, and Efficacy.
Pharmaceutical firms increased the number of product development by using scientific tools such as QbD (Quality by Design) and PAT (Process Analytical Technology).
ICH guidelines Q8 to Q11 have discussed QbD implementation in API synthetic process and formulation development.
ICH Q11 guidelines clearly discussed QbD approach for API synthesis with examples.
Generic companies are implementing QbD approach in formulation development and even it is mandatory for USFDA perspective.
As of now there is no specific requirements for AQbD (Analytical Quality by Design) and PAT in analytical development from all regulatory agencies.
In this review, authors have discussed the implementation of QbD and AQbD simultaneously for API synthetic process and analytical methods development.
AQbD key tools are identification of ATP (Analytical Target Profile), CQA (Critical Quality Attributes) with risk assessment, Method Optimization and Development with DoE, MODR (method operable design region), Control Strategy, AQbD Method Validation, and Continuous Method Monitoring (CMM).
Simultaneous implementation of QbD activities in synthetic and analytical development will provide the highest quality product by minimizing the risks and even it is very good input for PAT approach.
American Psychological Association (APA)
Raman, N. V. V. S. S.& Mallu, Useni Reddy& Bapatu, Hanimi Reddy. 2015. Analytical Quality by Design Approach to Test Method Development and Validation in Drug Substance Manufacturing. Journal of Chemistry،Vol. 2015, no. 2015, pp.1-8.
https://search.emarefa.net/detail/BIM-1067463
Modern Language Association (MLA)
Raman, N. V. V. S. S.…[et al.]. Analytical Quality by Design Approach to Test Method Development and Validation in Drug Substance Manufacturing. Journal of Chemistry No. 2015 (2015), pp.1-8.
https://search.emarefa.net/detail/BIM-1067463
American Medical Association (AMA)
Raman, N. V. V. S. S.& Mallu, Useni Reddy& Bapatu, Hanimi Reddy. Analytical Quality by Design Approach to Test Method Development and Validation in Drug Substance Manufacturing. Journal of Chemistry. 2015. Vol. 2015, no. 2015, pp.1-8.
https://search.emarefa.net/detail/BIM-1067463
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1067463