Improving Quality with PAT: Akums Drugs and Pharmaceuticals Success Story
Introduction
Process analytical technology (PAT) is a collective term for various tools and is often considered an essential aspect of other innovative endeavors. Although PAT has been a notion for some time, the pharmaceutical sector is just now adopting it. PAThas emerged as a critical instrument in the pharmaceutical business for enhancing product quality, boosting efficiency, and decreasing waste. Manufacturers may monitor and regulate crucial quality factors in real-time by applying modern analytical tools and methodologies, resulting in consistent and higher-quality products.
Process analytical technology (PAT) is a collective term for various tools and is often considered an essential aspect of other innovative endeavors. Although PAT has been a notion for some time, the pharmaceutical sector is just now adopting it.
Akums aims to utilize advanced pharmaceutical science and engineering principles and knowledge at every stage of a product’s life cycle to enhance the effectiveness of manufacturing and regulatory processes.
What is PAT?
Process analytical technology (PAT) is a framework for planning, evaluating, and managing manufacturing operations through accurate measurements of the vital properties of raw materials and materials already in use. PAT’s main objective is to guarantee constant quality throughout the medication production process by continuously monitoring important variables and making necessary modifications.
The FDA and the ICH have widely endorsed PAT as a method of ensuring the consistent production of high-quality products by continually monitoring and controlling critical activities. This approach integrates quality into the process rather than inspecting it in the final product (QbD), and it also promotes greater operational efficiency.
Can PAT improve product quality?
Designing, analyzing, and appropriately controlling the production process is the goal of the process analytical technology method. This dynamic approach’s characterization of CPPs( Critical Process Parameters) that have an impact on product-specific CQAs(Critical Quality Attributes) is a significant component. In reality, mechanistic knowledge of how formulation and process parameters impact product performances should serve as the foundation for product and process specifications. Monitoring these indicators, preferably in-line or online, helps to better understand production processes, which improves testing and decision-making regarding product quality while lowering waste and total costs.
Adaptation and selection PAT in pharmaceutical manufacturing can aid in:
- The design of effective and efficient production processes ensures product quality and performance.
- Product and process specifications are founded on a mechanistic understanding of how formulation and process variables influence product performance.
- Throughout the process, continuous real-time QA is performed.
- Risk-based regulation methods acknowledge the amount of scientific understanding of how formulation and manufacturing process variables influence product quality and performance, as well as the capacity of process control measures to minimize or lessen the risk of generating a low-quality product.
To accomplish this pharmaceutical companies need to adopt PAT integrated systems approach to monitor and maintain product quality. The objective should be to optimize the use of modern technology to improve manufacturing efficiency and streamline regulatory procedures.
For PAT, Akums is one of the few pharmaceutical companies in India that incorporates spectroscopic methods like Fourier transform infrared (FTIR), near-infrared (NIR), mass spectroscopy (MS), and Raman spectroscopy, as well as chemometric multivariate analytic tools.