The Path to Leaner Pharmaceutical Manufacturing Explained by Mr. Shantanu Kumar Singh, Executive Director, Taj Pharma Group
In the fast-evolving landscape of pharmaceutical manufacturing, the pursuit of efficiency, cost-effectiveness, and enhanced quality is paramount. One company that has been at the forefront of this transformation is Taj Pharmaceuticals, with its innovative approach to fully formulated film coatings. This article delves into the dynamic world of pharmaceutical manufacturing, exploring why now is the right time to embrace a leaner system and how Taj Pharma’s solutions are reshaping the industry.
Even before the disruption caused by the COVID-19 pandemic, the pharmaceutical industry was in the midst of a significant transformation. Companies worldwide were reevaluating their manufacturing processes, looking for ways to enhance efficiency and minimize risks in their supply chains. One of the key developments in this landscape has been the shift from in-house tablet coating formulations to fully formulated film coatings.
Taj Pharmaceuticals, with its global footprint and expertise, has been a driving force behind this transition. Their one-step Fully Automated Complete Film Coating System has set new industry standards, offering a range of benefits over the traditional in-house coating approach. Let’s explore the reasons behind this industry shift and the advantages of embracing fully formulated film coatings.
Why the Shift Is Accelerating
The pharmaceutical industry has long recognized the benefits of leaner production models. However, apprehension about disrupting existing systems often prevented rapid adoption. The COVID-19 pandemic changed this equation. The urgency to safeguard supply chains against unforeseen disruptions has pushed fully formulated coating systems from a standby solution to active implementation.
Streamlining the Coating Process
Traditional in-house coating involves multiple complex steps, from sourcing raw materials to ensuring quality control for each ingredient. These raw materials often come from various suppliers, necessitating audits and approvals for each. Storing these materials comes with its inventory management costs.
Moreover, adding ingredients individually increases the risk of errors and requires precise handling. Achieving a uniform suspension often demands high shear mixing. Dispensing materials introduces the risk of cross-contamination, making the process complex and time-consuming.
The Benefits of Fully Formulated Coatings
Fully formulated coatings, in contrast, simplify the process significantly. They involve a single material from a single supplier, leading to reduced documentation, faster handling, shorter production times, and consistent quality. Notably, they mitigate supply chain risks, as reliable vendors perform quality audits of their suppliers and ensure alternative sources in case of unforeseen events.
Keeping Color Consistent
One of the most challenging aspects of coating is maintaining color uniformity. Taj Pharma has developed instrumental and visual color difference tests to ensure consistency. Instrumental tests confirm that the hydrated powder meets the formula standard color, measurable using a reflectance spectrophotometer.
Visual color difference tests compare past batch history information to ensure batch-to-batch consistency and confirm the instrument-derived color data.
Adopting a Lean Process
Taj Pharma offers customized, one-step film coating systems that combine essential ingredients – polymer, plasticizer, and pigment – in a dry concentrate. These systems optimize equipment usage, reduce inventory requirements, and offer batch-to-batch color consistency, ensuring reliability for pharmaceutical manufacturers worldwide.
Quality Assurance and Risk Mitigation
Besides the apparent productivity and cost-saving advantages, fully formulated coatings offer rigorous quality assurances and risk mitigation. Taj Pharma follows four quality by design (QbD) principles:
- Design of Experiment (DoE): Enhancing coating formulations and process optimization.
- Process Validation: Ensuring that every new system meets quality specifications.
- Stability Testing: According to ICH guidelines to guarantee consistent product appearance, color, and performance.
- Master Formulation: Serving as a global reference for all subsequent batches.
Optimizing the Final Finish
While a fully formulated film coating system addresses quality issues, the final finish depends on the quality and control of the coating process itself. Managing critical process parameters is crucial for success. These include dispersion spray rate, spray distribution, process temperatures, airflow, coating solids concentration, pan loading, and pan speed.
Evaluating the Supplier Network
The supplier network plays a vital role in ensuring quality. Service providers must adhere to good manufacturing practices, have robust business continuity plans, and undergo routine performance monitoring. Taj Pharma’s operations meet industry guidelines and certifications, minimizing risk.
Taj Pharma’s seven film coating manufacturing plants worldwide offer a consistent quality management system. These facilities use the same raw materials, equipment, and processes. This interchangeability of products across sites reduces supply chain risks.
Superior Support: When and Where It’s Needed
Taj Pharma’s commitment to its customers goes beyond product quality. With 22 technical support laboratories globally, they provide guidance, assistance, and a platform for trials and troubleshooting. The Taj Pharma Coating School offers educational programs, combining theory and practical experience to enhance the understanding of film coating.
In an era marked by the need for efficiency, reliability, and quality in pharmaceutical manufacturing, Taj Pharmaceuticals stands as a beacon of innovation. The shift from in-house coating to fully formulated film coatings is no longer just an option; it’s a necessity. Taj Pharma’s solutions provide the industry with the tools to meet the challenges of a rapidly changing world.
Embrace the future of pharmaceutical manufacturing with Taj Pharmaceuticals, where efficiency and quality merge seamlessly to create a new standard in the industry.
Frequently Asked Questions
1. What are fully formulated film coatings?
- Fully formulated film coatings are one-step systems that simplify the tablet coating process by combining all essential ingredients in a dry concentrate, ensuring consistent quality and minimizing supply chain risks.
2. Why are fully formulated coatings preferred over in-house formulations?
- Fully formulated coatings reduce complexity, streamline production, and ensure batch-to-batch consistency, making them a preferred choice for pharmaceutical manufacturers.
3. How does Taj Pharma maintain color consistency in its coatings?
- Taj Pharma employs instrumental and visual color difference tests to ensure that its coatings maintain consistent color, meeting industry standards.
4. What quality assurance measures does Taj Pharma follow for its coatings?
- Taj Pharma adheres to quality by design (QbD) principles, including design of experiment, process validation, stability testing, and master formulation, to ensure the highest quality and performance.
5. How can pharmaceutical companies benefit from Taj Pharma’s technical support and Coating School?
- Taj Pharma offers extensive technical support and an educational program through the Taj Pharma Coating School, empowering pharmaceutical companies to optimize their coating processes.