The pharmaceutical business is in a state of transition as the winning formula of “relying solely upon new drug development and time to market” is changing. The industry is getting increasingly concerned over counterfeiting, diversion, mishandling, mislabelling and unintended or mistaken administration of prescription drugs . Global competition, reduced patent protection, rising drug development cost, socio-political pressure for more affordable life saving drugs along with FDA initiatives are demanding a business model which gives greater emphasis on manufacturing performance.
As contamination of drugs is becoming a major problem for pharmaceutical companies particularly in the case of over-the-counter medications, security has become paramount to ensure that medications are not tampered with before they reach patients. Stakeholders at all junctures of the pharmaceutical supply chain – from point of vendors to point of care – recognize the importance of security. With legislations such as “e-pedigree adoption” by FDA, ‘Centralized Procedure’ for registering certain products often means that more than one language by EU. The industry is progressing closer to that goal greatly influencing the pharmaceutical packaging industry in a number of ways. Moreover pharmaceutical companies are taking steps to make their supply chain more efficient and effective.
What all these means is that packaging designers and manufacturers need to work harder than before to stay abreast of the latest laws, meet ethics requirements and use effective anti-tamper mechanisms while also taking into account sustainable packaging targets with the potential cost savings for pharmaceutical companies.
Thus improving manufacturing efficiency and meeting current and evolving regulatory requirements demands with changes in manufacturing automation architecture and employment of best practices have become more important than ever. Optimizing the efficiency of packaging operations requires an operations management infrastructure that integrates with the enterprise systems. Thus, pharmaceutical packaging manufacturing companies need to invest in enabling enterprise solutions with a collaborative approach to address the need for automating and streamlining the transactions and in automation systems for regulating the actual conversion process at the plant level.
Collaborative Principle is a unified approach which looks the whole thing from the point of view of an individual employee. From this standpoint, a single unified workspace, supporting individualized work processes and connected to the whole of the enterprise, allows each user to become one with the goals and processes of the enterprise. Fundamentally, applying collaborative principles to a packaging operation requires production visibility.
Production visibility in terms of unbiased and accurate information from packaging operations is essential for management to achieve productivity improvement targets and continuously improve on asset efficiency. In particular, for this strategy to have an impact requires a holistic view across the supply chain involving people both internal and external, business processes, and technology.
Converting information into knowledge to provide a consistent measure of asset utilization and performance across multiple facilities as well as obtaining an accurate baseline helps to better focus on improvements. Information consistency is a requirement in order to prioritize improvements and capital investments. On the factory floor, this information also provides line operators and team leaders with actionable data in real-time to help them make better decisions. The bottomline expectations from the implementation of a collaborative principle in packaging line operations are higher productivity, adherence to compliance, profitability and faster time to market. To achieve this, enterprise solutions are now an absolute necessity to operate production at optimal efficiency in the pharmaceutical business today.
Building such an infrastructure calls for appropriate automation system and enterprise solution infrastructure to be in place. In numerous instances, manufacturing companies are still saddled with legacy enterprise and automations systems built on proprietary operating systems which makes them difficult to share data with the enterprise solutions. Manufacturing companies must address these challenges if they are planning to implement and implement Collaborative Enterprise Solutions.
Collaborative Enterprise Solutions would not only bridge gap existing between packaging requirements and traditional production solutions but also manage production information at the item level. In addition to item-level tracking, a collaborative enterprise provides an infrastructure for the electronic transfer of production orders but also puts greater emphasis on inspection, labelling, coding, item-level electronic record keeping and line performance evaluation capabilities.
This helps in delivering a comprehensive operations management system that is an effective knowledge tool surpassing the basic functions of collecting and storing data. The ability to recognize and understand the implication of patterns and relationships between pieces of data and information is inherent in these combined solutions. The intention is to enable management and production personnel to make the best use of available knowledge to generate positive results that improve the performance of the entire value chain.
With globalization, the world has become a small marketplace. The competition among pharmaceutical manufacturers is intensifying for resources and markets. Nobody has a large staff anymore. So many times it’s a question of working on a new product and getting it to market versus redesigning or refining the packaging of an existing product. Collaborative Principles would help in optimizing packaging operations using consistent reliable metrics and analytical tools. Operations relying upon clipboards and manual record keeping cannot possibly provide the unbiased and real time metrics one needs to manage the ongoing change required to get peak performance out of your operations.
Collaborative enterprise provides an infrastructure that can be built upon like a strong foundation and if developed from the bottom up is an enabler to creating a completely integrated digital enterprise solution that extends down to the packaging lines. This is the concept behind building an infrastructure on the packaging line that allows for both monitoring and controlling the packaging process. Effectively, you want to move towards digital packaging lines where line changeover, inspection and data collection is all automated thereby eliminating manual intervention.
Yes, it is doubtful whether any packaging product can be truly ‘tamper free or even anti-counterfeitable’. All products can be copied in some form to look similar to the original. These similarities can often confuse the end user into believing they have the real product. The challenge is in enabling the end user themselves to check if the product is real .
(The author is Marketing Manager, Tectura India, Noida)