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Nayna Khedekar*, Vikram Veer, Ashok Bhosale, Archana Yadav, Tejaswini Kande
PDEA`s Shankarrao Ursal College of Pharmaceutical Sciences and Research Centre, Kharadi, Pune-14, Maharashtra, India.https://doi.org/10.33786/JCPR.2019.v09i04.026
Quality by design (QbD) is a new approach to product development that could increase product efficiencies, provide regulatory relief and flexibility, and offer important business benefits throughout the product life cycle. Quality by design (QbD) is a part of the modern advance to pharmaceutical quality. QbD is a quality in all pharmaceutical products. Under this concepts of be throughout design and growth of product. During design and development of a product in QbD, this need to desire product performance profile [Target product profile (TPP), Target Product Quality Profile (TPQP)] and identify critical quality attributed (CQA). It‟s also gives the comparison between product quality by end product testing and product quality by Quality by design. The application of quality by design (QbD) in pharmaceutical product development for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United State Food and Drug administration (USFDA) emphasized the principles and application of QbD in pharmaceutical development in their guidance for the industry. The plan of pharmaceutical development is to design a quality products and its manufacturing process always deliver the future performance of product. The base of Quality by Design is ICH Guidelines Q8 for pharmaceutical for development, Q9 quality risk management, Q10 for pharmaceutical quality systems. The main objectives of QbD is to the quality products, for the product and process characteristics important to desired performance must be resulting from a combination of prior knowledge and new estimation during the development of product. Quality by Design helps to reduce product variability and failures which help in achieving high quality pharmaceutical products.
Quality by design, Quality target product profile, Critical quality attributes, Design space, implementation of QbD, Quality risk management.
The authors declare that they have no conflict of interest.
Received: 17 July 2019
Accepted: 03 September 2019