India’s pharmaceutical industry, emerging as a leading player in the global generic market, is one among the best performing industries in India. The industry tracks the opportunities in the generic market, essentially created by the drugs coming out of the patent regime, and successfully applies and receives the necessary FDA approvals in time so that it can exploit the opportunities to the full. It has created the necessary FDA approved facilities to produce the drugs. In a market where the first mover has the advantage over other rivals only for a few months, it is necessary for companies to dominate the market by drastically reducing the time-to-market - from pilot production to bulk production, and ensure continuous productivity improvements. They need to invest in technology solutions that empower them to pursue the path of operational excellence and sustainable competitive edge.
Pharmaceutical Industry's Challenges
Typically, the pharmaceutical manufacturing process is batch oriented involving sample testing in laboratories, conducted to ensure quality. While this process of testing has been successful in delivering quality drugs to the market, it results in low yields in terms of both quality and quantity. It also results in batch rejection or rework, thereby increasing the overall cost of final product.
The major challenge faced by companies is to find new manufacturing strategies to accommodate more diverse product portfolios, varying and smaller batch sizes, and the need for greater production flexibility.
PAT - An Innovative Way to Achieve Continuous Process Improvements and Quality by Design
Process Analytical Technology (PAT) can help pharmaceutical companies to cope with these challenges as it focuses on the continuous process improvements as well as the consistent quality of end products, and generates real time data to increase the level of certainty throughout the process. In addition, the on-line monitoring technique of PAT is very useful not just for recording information, it also makes necessary adjustments to the process as well, while the product is under the manufacturing process. PAT can be implemented in both the lab and the plant and is a good tool that helps companies to pursue quality by design (QbD) goals.
PAT boosts collaboration between R&D and research department within companies and increases overall efficiency in process understanding as large number of processes are developed in their pilot plants, but very few get final approval for the production in their main plants due to deviations and errors associated with the process.
PAT is an innovative way to design and control the process in a way that minimizes any error or deviation and thereby leads to consistent product quality. Process Analytical Technology (PAT) helps pharmaceutical companies gain a good understanding of the processes and thereby ensure final quality products. It is an online process control system that facilitates the transfer of knowledge gained in the laboratory to the production line. A PAT framework helps in achieving a deeper understanding of the production processes and the critical control parameters while ensuring final product quality. Adherence to PAT guidelines ensures identification of the sources, manage the process variability attributes, and accurately and reliably predict the final product attributes.
Benefits of PAT
PAT is a structured and formalized way of looking at the processes to ensure better quality of final products by its design itself and controls the manufacturing process by timely measurement and control of critical quality and performance attributes at all stages from raw material to the final products. This ensures fewer batch failures, reduces cycle time, increases operating efficiency, and improves the workflow. PAT reduces the risk of processing errors and minimizes products’ variability by on-line measurements.
The application of PAT helps in the creation of a knowledge base, which consists of both a scientific understanding of the relevant multi-factorial relationships between formulations, process, and quality attributes, as well as a means to evaluate the applicability of this knowledge in different scenarios.
The benefits of implementing PAT will not be dramatic in the short term. It is an essential investment for companies that seek continuous quality improvements and sustainable development over a long-term period.
The Last Word
ARC believes that pharmaceutical companies in India must invest in technologies that help them achieve operational excellence while fostering internal and external collaboration. The industry must focus on leveraging technology to exploit fully the global growth opportunities.
According to ARC research, some of the leading suppliers of PAT are ABB, Aegis Analytical, GE, Perkin Elmer, Rockwell Automation, Siemens, and Solvias.