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CMC and GxP

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Abstract:

Chemistry, manufacturing, and controls (CMC) focus on the steps to assess the physical and chemical characteristics of drug products, being applicable to the entire product lifecycle. It ensures that drug products are consistently effective, safe, and of high quality for consumers. There is another process, called good practice' guidelines and regulations (GxP), which is a collection of quality guidelines and regulations created to ensure that bio/pharmaceutical products are safe, meet their intended use, and adhere to quality processes during manufacturing, control, storage, and distribution. It is essential to attain these parameters to ensure that products are properly regulated and their best quality is achieved.

Tópico:

Biosimilars and Bioanalytical Methods

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Información de la Fuente:

FuenteElsevier eBooks
Cuartil año de publicaciónNo disponible
VolumenNo disponible
IssueNo disponible
Páginas455 - 456
pISSNNo disponible
ISSNNo disponible

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