Analytical Quality by Design Approach to Test Method Development and Validation in Drug Substance Manufacturing

N. V. V. S. S. Raman,Useni Reddy Mallu,Hanimi Reddy Bapatu

doi:10.1155/2015/435129

Abstract

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.

Highlights

Pharmaceutical industry has focused on product Quality, Safety, and Efficacy
Product quality has been increasing by implementing scientific tools such as QbD (Quality by Design) and process analytical technology (PAT) (Process Analytical Technology)
Method control strategy does not appear dramatically different under the Analytical Quality by Design (AQbD) approach when compared to the traditional approach

Summary

Introduction

Product quality has been increasing by implementing scientific tools such as QbD (Quality by Design) and PAT (Process Analytical Technology). Scientific approaches will provide the clear and sufficient knowledge from product development to manufacturing. These QbD tools will minimize the risk by increasing the productivity and quality. As per ICH, QbD is defined as “A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.”. It is recommended to implement QbD approach in analytical method development termed as AQbD.

AQbD Method Validation

Literature search and initial risk assessment

Procedure monitoring

Control Strategy and Risk Assessment

Conclusion