Issue
Article Subject
Pharmacy
Abstract

Quality by design (QbD) is a new modern perspective towards the qualitative pharmaceutical development. Many pharmaceutical companies have used several Quality Management System (QMS) for instance ISO 9001. This is a systemic approach to design and development of the pharmaceutical formulations and manufacturing processes that ensures the predefined product quality. Pharmaceutical industry is moving towards quality. A process DOE was used to evaluate effects of the design factors on manufacturability and final product CQAs, and establish design space to ensure desired CQAs. Critical material and process parameters are linked to the critical quality attributes of the product. On the basis of the Information Company then design the product formulation and process to meet the product attributes. This leads to understand the impact of raw materials [critical material attributes (CMA)], critical process parameters (CPP) on the CQAs and identification and control sources of variability

Keywords
Quality by design
Design of experiment
Design space and critical materials attributes.
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