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Doe In Pharmaceuticals: Supporting Software And Future Prespects.
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| Author:
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, MR.HARIHARAN.R, DR.GNK.GANESH, MR.ARUN RADHAKRISHNAN, MR.JOTHI PRAKASH.K
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| Abstract:
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The new approach to develop quality in pharmaceuticals is by implementing Quality by Design (QbD). It explains the use of Quality by Design to guarantee pharmaceutical quality. In this review, the QbD is described and some of its components are specified. Even though the Quality can be checked on products, integrating within the design will be more effective. The quality by design is based on the ICH guidelines and USP also requires compendial product consistency evaluation checks on the market. As far as industry is concern - it is improving the quality and safety of their products by application of DoE using various software, since the cost of each software is higher, choosing the best software which has easy user interface as well as more performance is concerned. These QbD is implemented with creating DoE in the statistical application of production data with the help of various commercially available software (JMP®, MODDE®, MINITAB®, STATISTICA®, etc.,). The potential power of each software is unique and their functionalities are reviewed in this article. And it also gives you a brief idea about the software towards advancement in pharmaceutical sector in term of quality and safety.
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| Keyword:
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Quality by design (QbD), Design of Experiments (DoE), Critical Quality Attributes (CQA’s), Critical Process Parameters (CPP’s), Process Analytical Technology (PAT), classification and regression tree (CART).
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.02.030
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| Download:
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