Integrated Information and Control Technology Gives Drug Makers the Power to Win in the Marketplace

For most pharmaceutical manufacturers, introducing a drug to market is a race against time. There is a threat of expiring patents and the constant pressure to consistently meet stringent federal regulations in the manufacturing process. So, major modern drug makers need the competitive advantage offered by pairing sound manufacturing processes with cutting-edge and fully integrated control and information systems on the production line.

The FDA itself is advising drug makers to invest in technology to reduce human error and increase drug purity. In fact, its latest compliance guide – “Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval” – encouragesmanufacturers to increase the amount of their process documentation to provide the detailed records essential for speeded pre-market approval and ultimately, a faster race to the finish line.
The best way to do that, the FDA says, is by employing emerging automation and control technologies to improve batch quality. The FDA points out that the information automatically captured by computer-driven production systems not only speeds the drug-to-market time, but also helps drug makers fine-tune their own manufacturing processes and maximize efficiency. This is a big change from compliance guides of the past, for this is the first time that the FDA suggests using these advanced technologies for improved process understanding and quality control.

Clearly, the most efficient control and information systems are ones that are fully integrated, rather than those that include a segmented mish-mash of hardware and software. Even worse is collecting data by hand. The bottom line is that you need the most modern methods to win the race. That way, you protect your product, your profits and your reputation.

The Process Validation Lifecycle
For manufacturers that have to rigorously document their operations, the FDA highly recommends that manufacturers follow the process validation life cycle. The lifecycle includes four core steps: design, confirm, monitor and assess. Every step of the way, the key to success is advanced automated technology. Together, the lifecycle and a fully integrated control and information system can provide manufacturers with the real-time information needed to help manufacturers identify any deficiencies in quality and effectively control them. The documentation these tools provide also can help drug manufacturers clear the highest hurdle – FDA approval.  Following FDA guidance, manufacturers can use these tools to constantly enhance the quality of their products. 

Step One: Design
Different production lines have different required process and control parameters, depending on the drug. Ingredients vary, temperatures differ and packaging does too. Labels are almost always different depending on the drug. So on the production line, the hardware and software must be designed to carefully control and monitor all of these requirements. But not all components pass muster with the FDA. There are certain standards that manufacturing control systems must meet to satisfy federal regulators and stay on the fast track to validation.

When designing system architecture, drug makers must make sure that equipment is properly installed to operate at peak efficiency at all times. They also must incorporate programs within their process that have the ability to relay critical operating data and information – such as when a batch temperature is too high or a line is down – to technicians, engineers and executives. This can streamline risk assessment and troubleshooting.

Another point that manufacturers should consider when designing their system is selecting automated equipment that is ISA S-88 compliant— meaning that the equipment has the ability to separate its performance information from batch-related information. That way, through the use of various manufacturing software applications, drug makers can monitor the effectiveness of their equipment and attribute each piece of equipment to steps in a recipe. In worst-case scenarios, such as a batch irregularity, manufacturers can quickly identify the source of the problem and replace or modify equipment accordingly.

Additionally, by gathering and utilizing the data from other software applications in the production process and working through a manufacturing execution system (MES), you have the ability to instantly archive and distribute essential information about the manufacturing process to anyone who needs it in the plant. Such instant and accurate communication is only possible through the integration of the information layer and an information-enabled control system.

Step Two: Confirm
Many drug manufacturers have a variety of machines that gather data in different languages, such binary or XML. Regardless of the format, today’s advanced MES can interpret and share the information to people across the plant floor and on up to business-level systems through integration with an enterprise resource planning (ERP) system. Historical data provided by an MES also can help engineers regularly monitor how well their production machinery is working.
When tightly integrated with an information-enabled control platform, batch management software allows manufacturers to quickly and easily adjust their batch recipes by access to batch consistency data and recipe phases completed during each batch run. Because the information is pin-point accurate, it allows manufacturers to evaluate and remedy any problems at hand. This can dramatically reduce the length and cost of validation time.

To protect consumers, the FDA recommends that each drug batch meet the same consistent standards. Batch management software is a vital resource in this process because it captures data that can be used to prove the samples are quality and specifications.

Additionally, this type of software application generally includes a “batch journal”— a  feature that uses data captured by controllers to log and archive raw materials that go into the making of each drug. With the click of a mouse, an engineer can look at data collected at a certain date or time to determine weak links in production processes. This ability can help lower risk and the possibility of equipment failure.

Step Three: Monitor
Each piece of equipment has an effect on the end product, so each needs to work at peak performance. Many manufacturers are employing real-time performance management software to quickly reveal any variation in the process caused by glitches in the machinery.  Performance management software enables you see the materials, machinery and manpower dedicated to each batch.

If operators detect a problem, they can quickly address it by simply reviewing the computer based information. Operator-interface terminals provide drug makers with a portal into their processes. Machine-specific terminals allow operators to view real-time trend charts and statistical process control graphs related to production data, while scalable, “supervisory” terminals enable designated operators to access information from any aspect of production. Because of the information sharing capabilities of the MES, operators are provided with the data needed make sure processes are running smoothly and key business decision makers are provided with information they need for order scheduling and resource management.

Step Four: Assess
The high-tech tools that help drug makers reach validation also can enable them to manufacture their products most effectively.

The FDA’s latest validation requirements place a strong emphasis on post-production assessment to help manufacturers continually refine and improve their processes. Not only can drug makers get real-time feedback, but they can set regular data-gathering cycles, say, on a monthly or quarterly basis, to monitor the success of any changes. The information provided through an MES also can help determine key business decisions, such as whether more employees are needed on the line – or fewer. 

Finally, this advanced approach makes it easier for manufacturers to change any procedure, no matter how small, without affecting the validation of the entire process. 

The FDA mandates that drug makers document any procedural changes in a post-market report. Information on the strength, quality, purity and potency of the product is automatically captured and archived using the latest technology, saving drug makers valuable time and money.

Without accurate information, drug manufacturers may fall short of the finish line in the race to market. By building sound manufacturing practices into the drug development process and leveraging fully-integrated control and information systems, manufacturers have the power to achieve a winning performance.