A Critical Review on Recently Used PAT in Pharmaceutical Industry
Arti Swami, Shivani Chakankar, Prajakta Chavan, Dnyanesh Limaye, Amol A. Tagalpallewar
Abstract
Arti Swami, Shivani Chakankar, Prajakta Chavan, Dnyanesh Limaye, Amol A. Tagalpallewar
Abstract
Quality of pharmaceutical product is of principle importance by all the regulatory bodies. Failure to meet such quality expectations can lead to massive shift of pharmaceutical companies in share of market. The pharmaceutical industry is supremely regulated industry as it is managed by convincing regulatory bodies. Process analytical technology (PAT) is a method to plan, examine and regulate pharmaceutical manufacturing procedures by examining critical process parameters influencing the critical quality attributes. PAT has been used in manufacturing processes in pharmaceutical industries from decades. PAT involves utilizing diverse techniques and tools to construct quality in pharmaceutical products both physically and chemically by testing at one or more intermediate processing steps. This review endeavors to discover perception tools, goal line, PAT tools in manufacturing, its working and applications, regulatory considerations and benefits. The applications of NIR spectroscopy have extended the added advantages in pharmaceutical industry.
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Quality of pharmaceutical product is of principle importance by all the regulatory bodies. Failure to meet such quality expectations can lead to massive shift of pharmaceutical companies in share of market. The pharmaceutical industry is supremely regulated industry as it is managed by convincing regulatory bodies. Process analytical technology (PAT) is a method to plan, examine and regulate pharmaceutical manufacturing procedures by examining critical process parameters influencing the critical quality attributes. PAT has been used in manufacturing processes in pharmaceutical industries from decades. PAT involves utilizing diverse techniques and tools to construct quality in pharmaceutical products both physically and chemically by testing at one or more intermediate processing steps. This review endeavors to discover perception tools, goal line, PAT tools in manufacturing, its working and applications, regulatory considerations and benefits. The applications of NIR spectroscopy have extended the added advantages in pharmaceutical industry.
Key concepts: Pharmaceutical industry, Pharmaceutical manufacturing, Quality (philosophy), Critical quality attributes, Product (mathematics), Quality by Design, Process analytical technology, Process (computing)