Pharmaceutical Drug Product Development and Process Optimization: Effective Use of Quality by Design

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For decades the pharmaceutical sector has been considered as one of the most regulated markets across the globe, which continuously strives to deliver quality products for the patient’s benefit. Usually, pharmaceutical product development involves diverse varieties of functional and nonfunctional substances, including active ingredients, excipients, polymers, etc., along with the entire manufacturing process that constitutes of multistep operations and is associated with multiple factors that need to be controlled for producing drug products with desired quality. Due to the involvement of multiple factors, the goal of achieving consistent product quality is always a great challenge for pharmaceutical scientists. Several regulatory initiatives have been undertaken so far to maintain the quality of drug products manufactured with utmost batch-to-batch consistency. One of the most vital initiatives was made by federal regulatory agencies, the United States Food and Drug Administration (USFDA) and International Conference on Harmonization (ICH) the implemented quality practices into manufacturing. In this regard, the concept of Quality by Design (QbD) was instituted as a relatively newer pharma paradigm, which particularly focuses on the systematic development of drug products with predefined objectives to provide enhanced product and process understanding. QbD has ultimate utility in the systematic development of drug products with consistent quality and minimal defects in the end.
LF/384317/R
Data sheet
- Name of the Author
- (eds.)
Mahfoozur Rahman
Majed Al Robaian
Nabil Alruwaili
Sarwar Beg
Sunil Kumar Panda
Syed Sarim Imam - Language
- English
- ISBN
- 9781771888721
- Release date
- 2020