by Michael Lyle
January 13, 2012
The motivations for maintaining an effective quality control platform in the pharmaceutical industry are clear. It hasn't even been two years since Johnson & Johnson suffered losses of $665 million due to quality control lapses across product lines, sites and business units. Products affected included children's Tylenol liquid and adult Tylenol, Mylanta, Motrin, Pepcid AC and Rolaids.
Manufacturers, especially those within the pharmaceutical industry, have always watched their processes and production flows within their four walls very closely. Today, that is not enough.
With increased competition, and stricter standards, regulations and initiatives, such as the U.S. Pharmacopeial Convention's (USP) proposed Good Distribution Practices set to be published in May of this year, it is more important than ever for pharmaceutical manufacturers around the world to look beyond their own operations and implement real-time quality control solutions throughout their entire supply chain. This ensures the quality and safety of not only the final products, but also the raw materials and components produced along the way.
Detailed reporting and analysis enable both forward and backward traceability to ensure compliance, determine origination or identify-specific use within the manufacturing process.
To do this, it is imperative for manufacturers to not only monitor their own processes and inspect incoming products, but also have a true understanding of their entire supply chain, and the quality of the products and raw materials they receive from their suppliers, as they are being produced. This means that manufacturers need to find a way to monitor processes throughout the supply chain, in real time, to ensure products are cost effectively meeting quality expectations, while complying with the ever-increasing federal and local regulations, and traceability requirements.
The first step is to develop strategic supplier partnerships based on a shared approach to real-time process data. The fastest way to mitigate adverse events is to monitor data, and send real-time alerts when process abnormalities occur. Doing so also provides a stronger understanding of supplier performance and generally results in a more efficient, streamlined supply chain.
Through these partnerships, manufacturers can establish global quality initiatives based on the quality elements that are most relevant to their own processes, and know for certain that all products they receive meet inspection requirements. This high level of monitoring and analysis is achieved using real-time statistical process control (SPC) and creates end-to-end visibility into manufacturing processes.
The challenge of implementing a real-time quality control or SPC system throughout the supply chain is how to best assimilate data from various supplier systems that previously had existed in individual, unique environments. By taking advantage of advancements in mobile technologies and hardware, there are a wide variety of flexible deployment options that accommodate nearly any established-or nonexistent-- quality system. From full scale, on-premise implementations, to on-demand Software as a Service (SaaS) deployments, or even a hybrid model that uses both, real-time data can easily be collected and analyzed in a central quality hub.
With this centralized quality hub, manufacturers and suppliers alike can monitor and analyze processes at all levels of the supply chain in real time. This offers the ability to identify, acknowledge and eliminate out-of-specification product before an entire lot or batch is affected.
By ensuring such a high level of quality throughout the entire supply chain, pharmaceutical manufacturers can avoid the costly ramifications of a public recall due to a defective product-from active drug ingredients to excipients-reaching the consumer. Such recalls can not only affect immediate sales as product is pulled from customer inventories, but also future sales based on the damage to the company's reputation because a consumer was hurt, became ill, or worse, died.
Selecting a real-time quality control solution that is flexible enough to adapt to and enhance a pharmaceutical manufacturer's operational environment while integrating suppliers' disparate systems, will ensure a smooth, successful transition to 100-percent supply chain visibility.
Investing in the appropriate system and training employees to take ownership of quality objectives will quickly yield an exponential return on investment through increased process performance and decreased waste. The ROI will only continue as users enjoy the benefits of automation, detailed SPC analysis and reporting, and real-time data monitoring. The right quality system allows for a smoother auditing process and maintains full compliance with regulations such as 21 CFR Part 11.
In the pharmaceutical industry, the public safety risks are too high to cut corners in quality control. The technology available today allows for a more collaborative supply chain that drives efficiency using real-time process data. A more streamlined supply chain is a competitive edge that increases speed to market and, most importantly, guarantees the safety of the pharmaceutical manufacturer's loyal customers.
About the Author
Michael Lyle is the founder and CEO of InfinityQS International, the leading provider of real-time quality control solutions to global manufacturers. His leadership and vision for InfinityQS are the foundation for the company's success and rapid growth. His adherence to a customer-driven development approach has ensured that InfinityQS products continue to address the growing, complex needs of the manufacturing industry. Lyle has a black belt in Tae Kwon Do and enjoys spending time with his wife and five sons.