Abstract
Very recently, Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical approach. The concept of QbD applied to analytical method development is known now as AQbD (analytical quality by design). It allows the analytical method for movement within method operable design region (MODR). Unlike current methods, analytical method developed using analytical quality by design (AQbD) approach reduces the number of out-of-trend (OOT) results and out-of-specification (OOS) results due to the robustness of the method within the region. It is a current trend among pharmaceutical industry to implement analytical quality by design (AQbD) in method development process as a part of risk management, pharmaceutical development, and pharmaceutical quality system (ICH Q10). Owing to the lack explanatory reviews, this paper has been communicated to discuss different views of analytical scientists about implementation of AQbD in pharmaceutical quality system and also to correlate with product quality by design and pharmaceutical analytical technology (PAT).
Highlights
The concept of quality by design (QbD) in pharmaceutical industry has been introduced to enhance robust manufacturing process, to facilitate product quality, and to manufacture products in terms of “six sigma.” The PUCC is a loop process, implemented for continuous improvement
Most of works were not enough to define the way of implementation of analytical quality by design (AQbD), because people felt that implementation of DoE in analytical method is QbD and it is incorrect
There are many questions which still exist among regulatory expertise, and the concept of QbD in analytical method development became a continuing interest to discuss and to learn more
Summary
The concept of quality by design (QbD) in pharmaceutical industry has been introduced to enhance robust manufacturing process, to facilitate product quality, and to manufacture products in terms of “six sigma.” The PUCC (process of understanding the control and capability) is a loop process, implemented for continuous improvement. International conference on hominization (ICH) Q8 (R1) guideline defines QbD 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” [3]. Most of works were not enough to define the way of implementation of AQbD, because people felt that implementation of DoE in analytical method is QbD and it is incorrect These reports have reflected the inadequacy of knowledge on analytical target profile (ATP), method performance characteristics, risk assessment, choice of DOE tool in QbD process, optimization of MODR region and its verifications, and so forth. There are many questions which still exist among regulatory expertise, and the concept of QbD in analytical method development (to be termed as AQbD) became a continuing interest to discuss and to learn more
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