Pharmaceutical companies working towards ‘perpetual regulatory readiness’

Indian pharmaceutical companies in India are working to transition from ‘Inspection Readiness’ to ‘Perpetual Regulatory Readiness’. That is according to research from Vector Consulting Group. Chandrachur Datta, senior partner at the management consultancy, outlines the drivers behind the trend.

In light of growing focus on regulatory compliance around safety and quality, pharmaceutical companies need to adopt a consistent, high-standard approach to quality management in labs and plants, known as ‘Perpetual Regulatory Readiness’, as opposed to preparing specifically for inspections (‘Inspection Readiness’).

Implementing rigorous scientific methods for root cause analysis (RCA) of both major and minor quality incidents in labs rather than routinely attributing issues to analyst errors can significantly reduce quality management system (QMS) instances. This approach will help Indian companies achieve the highest quality standards, aiming for only one or zero QMS events per month.

Even across research labs, there is a concern for wastage of capacity in the work done by analysts. More than 10% to 20% of the analyst capacity in many labs is wasted in activities of queuing, searching for lab consumables, and dealing with overheads of many avoidable quality incidents.

A similar approach needs to be taken in manufacturing. Going forward, companies will have to plan for a perpetual high-quality culture in plants. The higher costs of quality in plants can also be offset by gains in operational efficiency. In generic formulations, to ensure readiness for highly regulated markets like the US, Indian pharma needs to make strategic investments, particularly on records of work in progress (WIP) across different locations.

Now this is largely existing due to typical ERP configurations, which only provide production confirmations.

Without detailed WIP visibility at the work centre, it is challenging for both the companies and the regulatory authority to monitor compliance of Good Manufacturing Practices (GMP). Issues related to contamination, equipment malfunctions, or procedural errors that may occur at specific work centres might not be apparent in aggregate data, either. This can lead to poor quality of documentation, delays in corrective actions which potentially lead to unresolved issues affecting product quality.

The lack of real-time visibility into WIP also prevents plants from identifying bottlenecks. Without this transparency, they miss opportunities to enhance output and cost efficiency by addressing constraints at the work centre-level through minor investments or additional manpower.

These opportunities to enhance output are often viewed solely as costs, impeding efforts to drive continuous improvements. For instance, in some plants, setup times have remained unchanged for many years, and machine run times have not been optimized for higher speeds despite operating below approved speeds. A small additional investment in R&D capacity to reengineer these drugs to ensure stability at higher speeds will go a long way in improving operational efficiency.

Firms that have invested in digital tools to gain end-to-end supply chain visibility, including real-time tracking of work centres in production, and implemented targeted productivity programs, have not only improved operational transparency but also achieved a 20% to 30% increase in output. With only small investments in a few key constraint areas, this has led to a 15% to 25% reduction in cost per tablet.