AGS Pharma Consulting specializes in Quality by Design, Design of Experiments, Process Analytical Technology, Quality Risk Management, Statistical Process Control, and enhancing cost, quality, efficiency and Process Scale-up (API). We offer tailored consultations for pharmaceuticals, biotechnology, specialty, fine chemicals, and food. For more details on any of our services, please contact us.
Quality by Design (QbD) is a systematic approach to development that emphasizes predefined objectives, a deep understanding of both product and process and rigorous process control, all grounded in sound science and quality risk management. The U.S. Food and Drug Administration (FDA) is urging pharmaceutical companies to adopt this science and risk-based approach in product development and manufacturing. Enhanced testing alone does not improve product quality; instead, quality must be inherently built into the product from the outset.
AGS Pharma Consulting provides comprehensive training and consulting services for implementing Quality by Design (QbD) in the development of drug substances, drug products, and analytical methods. Dr. Samanta brings extensive experience in applying QbD to API, formulation, and analytical method development. He has successfully redeveloped over 30 high-value drug substances to enhance yield, quality, and efficiency. The total number of products developed by Dr. Samanta is detailed below:
Dr. Samanta has extensively discussed the application of Quality by Design (QbD) in his peer-reviewed publications:
Course Outline:
The generic pharmaceutical industry is experiencing rapid growth, with a heightened focus on quality and intensified market competition. As product complexity increases daily, the Design of Experiments (DOE) emerges as a crucial tool for enhancing processes, cutting costs through yield optimization, and minimizing process failures while boosting product quality. DOE provides a systematic approach to improving processes by examining the relationship between inputs and outcomes. As a core component of the Quality by Design (QbD) framework, DOE is extensively utilized across the biotech industry and other sectors.
AGS Pharma Consulting provides specialized training and consulting services for implementing the Design of Experiments (DoE) in the development of chemical compounds, drug substances, drug products, and analytical methods. Our services include selecting the appropriate experimental designs, analyzing, and interpreting data, and predicting outcomes from the models. Additionally, we support establishing the normal operating range within the design space using Monte Carlo simulation and process capability assessments (Cp and Cpk).
Dr. Samanta has extensively discussed the application of Design of Experiments (DoE) in his peer-reviewed publications:
Course Outline:
Process Analytical Technology (PAT) is a system designed to analyze and control manufacturing processes through real-time measurements of critical quality attributes, ensuring the final product meets desired quality standards. PAT is crucial for enhancing process understanding and enables real-time monitoring and release of products at a commercial scale. As a key component of Quality by Design (QbD), PAT focuses on continuous monitoring throughout the manufacturing process to ensure product quality, rather than relying solely on end-product testing.
AGS Pharma Consulting provides comprehensive training and consultancy services for implementing Process Analytical Technology (PAT) in both R&D and manufacturing. Our approach enables the creation of high-quality products while maximizing manufacturing efficiencies, achieving right-first-time outcomes, reducing time to market, and realizing cost savings. We achieve this by integrating multivariate data and real-time chemometric process models to predict Critical Quality Attributes (CQAs) from spectral data measured by specialized PAT analytical instruments. Our support extends to the implementation of PAT for various processes, including reaction monitoring, crystallization, polymorphism, blend uniformity (BU), content uniformity (CU), and moisture content in formulated products.
Dr. Samanta has explored the implementation of Process Analytical Technology (PAT) in his published papers:
Course Outline:
Quality Risk Management (QRM) is a systematic approach to identifying, assessing, and controlling risks to product quality throughout its lifecycle. Far from being merely a regulatory requirement, QRM is a core philosophy that underpins excellence in the pharmaceutical industry. By employing structured risk assessment and mitigation strategies, companies can enhance product quality, reduce costs, improve operational efficiency, and ensure regulatory compliance.
AGS Pharma Consulting plays a crucial role in guiding organizations through the practical implementation of Quality Risk Management (QRM) approaches, enhancing efficiency and meeting regulatory expectations. Our interactive, advanced workshop utilizes case studies to offer practical tools and techniques for addressing current challenges. Participants gain hands-on experience in preparing for and conducting risk assessments.
Dr. Samanta has extensively discussed the application of Quality Risk Management (QRM) in his peer-reviewed publications:
Course Outline:
Statistical Process Control (SPC) is a statistical technique used to measure, monitor, and control processes. It provides a scientific approach to managing and improving processes by identifying and eliminating special cause variations. As manufacturing businesses face challenges due to rising raw material costs and operating expenses, it becomes crucial for them to focus on cost reduction, increased efficiency, and quality improvement in their processes.
AGS Pharma Consulting provides in-depth training on enhancing the cost, quality, and efficiency of high-value products through the application of Statistical Process Control (SPC), root cause analysis, re-optimization, and process control techniques.
Dr. Samanta has extensively addressed improvements in the quality, yield, and efficiency of a high-value product in his AIChE conference proceedings.
Course Outline:
Organic Process Research & Development, 27(5), 875-889, 2023