Abstract

PROCESS ANALYTICAL TECHNOLOGY (PAT) AND QUALITY BY DESIGN: AN INTEGRATIVE APPROACH FOR PHARMACEUTICAL SCIENCE

Vivek Sharma* and Hitesh Kumar

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Abstract

Pharmaceutical production uses process analytical technology to examine the physical and chemical properties of raw materials, whether offline, in-line, or online. Manufacturing processes have been using process analytical technology for decades. PAT calls for a transition from assessing product quality to incorporating it into the product at several intermediary levels. It demands in particular that there be proven quantitative, causal, and predictive linkages among the basic elements. By doing this, the likelihood of contamination and cross-contamination is reduced. Additionally, it saves a significant portion of the time and money needed for product sample and analysis. Overall, PAT lays the path for generating a quality product, meeting consumer expectations and enhancing the organization's brand. PAT that will promote the voluntary development and application of novel analyzer technologies as well as innovative pharmaceutical development, production, and quality assurance methods. The contemporary method for pharmaceutical product quality is called "Quality by Design." This essay provides information on Pharmaceutical Quality by Design (QbD) and discusses how it is used to guarantee the high calibre of pharmaceuticals. Some of the components of the Quality by Design are described and mentioned. Pharmaceutical development aims to create a high-quality product and its production method to achieve the product's desired performance consistently. Products cannot be checked for quality, but quality should be incorporated throughout design. Critical quality characteristics, the Quality Target Product Profile, and important Quality by Design components are all included. Additionally, it compares the quality of products as determined by end-product testing with quality by design. ICH Guidelines serve as the cornerstone of Quality by Design. It is based on the ICH Guidelines Q8, Q9, and Q10 for pharmaceutical quality systems and pharmaceutical development, respectively. Additionally, it discusses the use of Quality by Design in pharmaceutical product development and manufacturing.

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