QBD in Analytical Method Development and Validation: A Review

Autor: Obaid Shaikh, Zahid Zaheer, Rana Z Ahmad, Tazim Shaikh
Jazyk: angličtina
Rok vydání: 2019
Předmět:
DOI: 10.5281/zenodo.3249783
Popis: Quality advisedly is the current approach to the category of prescription drugs. The aim of the pharmaceutical development is to provide a prime quality factory-made product and its manufacturing technique to often deliver the approaching performance of the products. Quality can not be tested into product however quality ought to be inbuilt advisedly. It's a vital part of the trendy approach to pharmaceutical quality. During this construct of QBD, it's essential to stipulate need product expression profile [Target Product Profile ( TPP), Object Product Quality Profile (OPQP)] and spot important quality attributed (CQA). On the bottom of this, we are able to style the merchandise formulation and method to fulfil the merchandise qualities. This lands up in recognizing the impact of raw materials [critical material attributes (CMA)], necessary technique parameters (CPP) on the CQA sand Identification and management sources of variability.
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Databáze: OpenAIRE
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