Pharmaceutical Quality by Design: Product and Process Development, Understanding, and Control
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The purpose of this paper is to discuss the pharmaceutical Quality by Design (QbD) and describe how it can be used to ensure pharmaceutical quality.
Materials and Methods
The QbD was described and some of its elements identified. Process parameters and quality attributes were identified for each unit operation during manufacture of solid oral dosage forms. The use of QbD was contrasted with the evaluation of product quality by testing alone.
Defining target product quality profile
Designing product and manufacturing processes
Identifying critical quality attributes, process parameters, and sources of variability
Controlling manufacturing processes to produce consistent quality over time
Using QbD, pharmaceutical quality is assured by understanding and controlling formulation and manufacturing variables. Product testing confirms the product quality. Implementation of QbD will enable transformation of the chemistry, manufacturing, and controls (CMC) review of abbreviated new drug applications (ANDAs) into a science-based pharmaceutical quality assessment.
Key Wordspharmaceutical quality by design pharmaceutical quality by testing process control process design process parameter process variability product design quality attribute question-based review
The authors would like to thank Drs. Gregory Amidon, Yihong Qiu, John Strong, Alan Parr, Mansoor Khan, Vincent Vilker, Robert Lionberger, Andre Raw, Lai Ming Lee, Lawrence Sau Lee, Wallace Adams, Doan Nguyen, Michelle Bryden, Gary Buehler, Helen Winkle, and Janet Woodcock for their valuable suggestions.
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