On one hand Indian Pharma industry is rapidly achieving a distinctive position in the global pharma space and on other hand domestic market is full of challenges like Volatility, Uncertainty, Complex & Ambiguous market, Increased competition, Quality, etc. So the big question is how a forward looking pharma company can achieve Operational Excellence. How Indian Pharma is paying the price for Jugaad in Quality control?
Over the last decade many progressive organizations have started adopting Lean/Kaizen® to improve their efficiency and have realized benefits in their operations but still many organizations needs to think about Operational Excellence as they are still not ready to embrace operations improvement initiatives due to lack of lack of proactive approach in understanding the challenges, multiple initiatives running at the same time & inadequate leadership focus & vision.
Indian pharma industry needs to move towards operational excellence to predict and prevent shortcomings in production practices. This would be the only way to ensure operational excellence which is the ultimate strategy for regulatory compliance. The Indian pharma is focused on delivering high quality drugs to patients but with a limited understanding of the processes. Now there is need to rework on the rejects and decline the variability of drug contents. There is need to move away from mere blind compliance, said AG Raghu, technical director, Gland Chemicals Pvt. Ltd. (Source: www.pharmabiz.com)
We have noticed that Lean thinking, KAIZEN™ philosophy, tools and techniques have brought about significant benefits to a large number of companies in a wide array of industry sectors across the world; and their success is well documented.
In the challenging and demanding environment of pharmaceutical industry where process control and process reliability play an immensely critical role, KAIZEN™ implementation could be greatly beneficial in delivering a competitive edge to an organization. Gaining a thorough understanding of every process and striving to improve every process continuously is a fundamental tenet of KAIZEN™ thinking.
Pharmaceuticals industry requires a paradigm shift to deal with the challenges
Our experience in different pharmaceuticals companies worldwide has demonstrated a clear correlation between Lean implementation and overall business performance. there is a clear need to increase capacity while reducing operating costs to stay competitive in the market sector.
- Processes not robust and reliable
- Low first-pass-yield or first-time-right quality
- Sub-optimal equipment performance – low Overall Equipment Effectiveness (OEE)
- High changeover times
- Long production Lead Times
- Changing customer demand leading to high inventories
- Daily firefighting at production lines; and not enough time to focus of systematic improvement efforts
In our experience in working with a number of pharmaceutical companies worldwide, we have seen organizations gain a sustained long-term performance advantage through –
- Creating Robust process design and built-in quality
- Implementing SMED to reduce changeover times and maintain small batch sizes
- Initiating Total Productive Maintenance (TPM) to improve equipment performance
- Employing ‘Pull Production’ and ‘Just-In-Time Production & Logistics’ to reduce throughput times and inventories
- Engaging people in daily problem-solving leading to a culture of continuous improvement in the organization