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Research Journal of Topical and Cosmetic Sciences
Year : 2019, Volume : 10, Issue : 1
First page : ( 29) Last page : ( 33)
Print ISSN : 0976-2981. Online ISSN : 2321-5844.
Article DOI : 10.5958/2321-5844.2019.00007.4

Importance of Critical Quality Attributes in Biopharmaceuticals Development

Dr. Kumar Kotta Kranthi*

Department of Pharmaceutics, SKU College of Pharmacutical Sciences, S. K. University, Anantapuramu, Andhra Pradesh, India

*Corresponding Author E-mail: kranthikumarkotta@gmail.com

Online published on 18 April, 2020.

Abstract

Quality plays a major role in the pharmaceutical product development and approval. Various official procedures are required for product development. Critical quality plays a major role in the biopharmaceutical consideration. Critical quality attributes plays a major role in the process validation. Critical Quality Attributes (CQA) are chemical, physical, biological and microbiological attributes that can be defined, measured, and continually monitored to ensure final product outputs remain within acceptable quality limits. During this stage acceptable limit, baselines, and data collection and measurement protocols should be established. Data from the design process and data collected during production should be kept by the manufacturer and used to evaluated product quality and process control. The product quality issue arises, historical data would be essential in identifying the sources of errors and implementing corrective measures.

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Keywords

Critical Quality Attributes, physical, biological and microbiological attributes.

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