A Quality-by-Design Study for an Immediate-Release Tablet Platform: Examining the Relative Impact of Active Pharmaceutical Ingredient Properties, Processing Methods, and Excipient Variability on Drug Product Quality Attributes

2014 ◽  
Vol 103 (2) ◽  
pp. 527-538 ◽  
Author(s):  
Joseph Kushner ◽  
Beth A. Langdon ◽  
Ian Hicks ◽  
Daniel Song ◽  
Fasheng Li ◽  
...  
Keyword(s):  
Product Quality ◽  
Quality By Design ◽  
Drug Product ◽  
Active Pharmaceutical Ingredient ◽  
Immediate Release ◽  
Quality Attributes ◽  
Relative Impact ◽  
Design Study ◽  
Processing Methods ◽  
Excipient Variability

Quality by Design in Pharmaceutical Formulation

2019 ◽  
pp. 221-239
Author(s):  
Sundaramurthy Vivekanandan
Keyword(s):  
Quality By Design ◽  
Drug Product ◽  
Quality Attributes ◽  
Pharmaceutical Products ◽  
Design Approach ◽  
Critical Quality Attributes ◽  
Quality Product ◽  
Product Profile ◽  
Critical Material Attributes ◽  
Quality By Design Approach

Quality by design (QbD) is a systematic, scientific, risk-based approach to product development and manufacturing process to consistently deliver the quality product. In this chapter, application, benefits, opportunities, regulatory requirements involved in quality by design of pharmaceutical products are discussed. In quality by design approach, during development, the developer defines quality target product profile (QTPP) and identifies critical quality attributes (CQA). Critical process parameters (CPP) of unit operations which impacts critical quality attributes need to be identified to understand the impact of critical material attributes (CMA) on quality attributes of the drug product. Quality by design approach is defined in ICH guidelines Q8 – Pharmaceutical Development, Q9 – Quality Risk Management, Q10 – Pharmaceutical Quality System. This chapter describes the implementation of new concepts in quality by design like design of experiments to achieve design space, control strategy to consistently manufacture quality product throughout the product lifecycle.

scholarly journals QUALITY BY DESIGN APPROACH: REGULATORY NEED, CURRENT, AND FUTURE PERSPECTIVE

2021 ◽  
pp. 29-35
Author(s):  
AAYUSHI RAJORA ◽  
GURMEET CHHABRA
Keyword(s):  
Quality By Design ◽  
Raw Materials ◽  
Drug Product ◽  
Active Pharmaceutical Ingredient ◽  
Pharmaceutical Products ◽  
Future Perspective ◽  
Development Methodology ◽  
Unit Of Measurement ◽  
The Impact ◽  
Analytical Technology

Quality by design (QbD) is utilized in the event of pharmaceutical processes to create certain predefined product quality. QbD ideas unit of measurement explained in International Conference on Harmonization (ICH) pointers Q8 (R1) (Pharmaceutical development), Q9 (Quality risk management [QRM]), and Q10 (Pharmaceutical quality system). ICH Q8 (R1) guideline defines QbD as “a systematic approach to develop that begins with predefined objectives and emphasizes product and methodology, understanding, and methodology management, supported sound science and QRM.” QbD approach studied the implications of various input variables (e.g. methodology parameters, and materials) of the merchandise development methodology, on the final word product (active pharmaceutical ingredient or drug product). The late QbD approach integrates the principles of QRM, and methodology analytical technology (PAT). QbD combined with methodology analytical technology (PAT) tools modify methodology management and increase assurance that the merchandise quality attributes unit of measurement achieved consistently. An integrated and risk-based approach for review of the merchandise development methodology is also a future need of the QbD plan. Although implementing the QbD approach is not a restrictive demand, restrictive agencies to supply flexibility in their pointers for producing that unit of measurement developed by the QbD approach. Rising trends embody the growing interest in quantifying and managing the impact of raw materials’ attributes variability of methodology and product, what is more, as a result of the event of retrospective QbD approaches in complement to simple QbD. Thus, the QbD approach is also a tool for developing worth effective and quality pharmaceutical products.

Quality by Design in Action 1: Controlling Critical Quality Attributes of an Active Pharmaceutical Ingredient

2015 ◽  
Vol 19 (11) ◽  
pp. 1634-1644 ◽  
Author(s):  
Abdul Qayum Mohammed ◽  
Phani Kiran Sunkari ◽  
P. Srinivas ◽  
Amrendra Kumar Roy
Keyword(s):  
Quality By Design ◽  
Active Pharmaceutical Ingredient ◽  
Quality Attributes ◽  
Critical Quality Attributes
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