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, said AG Raghu, technical director, Gland Chemicals Pvt. Ltd.
A string of warning letters has put the pharma industry into microscopic scrutiny of regulators especially in India. In fact, the major findings by the regulators have been the inadequate laboratory systems together with the improper implementation of corrective action and preventive action (CAPA.) The companies will need to plan for zero defect product development and invest in achieving total quality not just in manufacturing but supply chain management, he added.
Traditionally, the pharmaceutical industry functions in a highly regulated environment and the regulators have taken the responsibility for product quality.
The Indian pharma is focussed 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, Raghu told Pharmabiz.
In a presentation titled ‘Operational Excellence the ultimate strategy on Regulatory Compliance’ during the IPA-Karnataka convention, he said that innovation and improvements have been constrained due to inflexible regulatory environment. But now with the regulatory authorities including the USFDA releasing a number of guidelines has led to a new paradigm shift. This has called for the need to comprehend the production processes which would create a culture of continuous improvement to systematically identify the causes of variability in the manufacturing process and achieve the model of being ‘right the first time’, he added.
“It is now evident that the global regulatory expectations are moving towards operational excellence where quality becomes the fabric of operation. For instance, quality and productivity are on FDA’s agenda to push the industry towards developing scientific understanding of pharmaceutical manufacturing process and persuade the use of innovative technologies. This is seen to provide new opportunities for the industry and pave the way for operational excellence,” Raghu said.
However, there are now challenges before the large, medium and small pharma companies in India to comply with increased regulatory expectations. There is need for effective implementation of ICH Q8, Q9, Q10 & Q11 to design robust systems to build proactive quality risk management integrated into production.
He said that operational excellence should be a management driven initiative because the biggest challenge would be engage the personnel in continual improvement. The team leaders should spend more time on the shop floor to enable companies to overcome organisation inertia to predict and prevent errors like presence of impurities in a formulation due to adulteration of active pharmaceutical ingredients or low excipients ratio leading to higher risk of reaction. There is need to eliminate use of poor quality container closure systems used in packaging. Therefore moving towards operational excellence would ensure efficiency, stated Raghu.