The US pharmaceutical industry (pharma) produces between 30-40% of the world’s drugs. Because its products have a direct effect on people’s health and welfare, constant and effective quality control is paramount. Thus, it is a highly regulated industry. The US Food and Drug Administration is the most prominent regulatory authority in this arena. Solid alarm management is critical to quality control in process-intensive industries like pharma. However, the complexity of the industry creates numerous challenges. Without robust technology, the process can get downright impossible to manage. TiPS LogMate and its components can help operators surmount those difficulties and achieve world-class pharmaceutical industry alarm management.
FDA guidelines for alarm management
The FDA recognizes and addresses system complexity and the need for alarm management with two key guidelines:
- Computerized Systems in Drug Establishments (February 1983).
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff (January 2002).
To summarize, the FDA expects that the processes and systems involved in pharma manufacturing, including alarms, are qualified and validated. This means they have to comply with Current Good Manufacturing Practices.
Key FDA requirements for pharma alarms are as follows:
- Alarm function documentation:
- All alarms that connect different process segments (e.g., formulation and blending process segments).
- What triggers alarms and the required responses.
- Alarm record keeping and historical archiving.
- Standard operating procedures for alarm maintenance.
- Functional requirements:
- Alarm systems must capture all data from the alarm devices.
- Alarm interfaces must be reliable for monitoring and responding to alarms.
- Operator responses must be documented so that when an alarm annunciates, the operator response is error-free.
- There must be an effective interface that monitors all alarms with a visual monitoring display.
FDA enforcement actions
The FDA conducts inspections, generally every 2-3 years. In the event of non-compliance, it may issue Form 483 to cite observed regulatory infractions. The facility then must promptly address these issues or face further regulatory actions.
Clearly, public safety, employee safety, quality control and regulatory compliance are compelling reasons for solid pharmaceutical industry alarm management. However, the daily reality of pharma manufacturing can make this a tall order. That’s where TiPS LogMate can save hundreds of man-hours and help ensure compliance.
Let’s delve into common challenges and ways that TiPS can help operators overcome them.
Five common challenges in pharmaceutical industry alarm management
1. The sheer number of combined building automation and process control systems without a standard interface
The pharmaceutical production process breaks down into several distinct steps such as blending, granulation, milling, coating, tablet pressing and capsule filling. The process centers on the chemical formulation of hundreds of products, each with specific ingredients at specific quantities at specific points in the process, under particular environmental conditions.
Therefore, quality control is of critical importance in pharma. Mistakes in dosage or formula can be expensive at best, and fatal at worst. Consequently, the process must be closely monitored for quality at every step of the way, with no margin for error.
The need for quality control, along with the size and complexity of pharma facilities, means that the total number of monitored alarms can run into the thousands, even hundreds of thousands or more. Even if rationalized, there are too many alarms to be annunciated at different places.
The principles of simplification and consolidation come into play here. There needs to be a single, standard interface to allow for pharmaceutical industry alarm management in one place. Such an interface would protect operators from overwhelm and allow them to prioritize accordingly.
The LogMate® netView module provides a customizable, holistic view of the alarm system. Without such a view, operators would be reduced to reading and responding to thousands of text alarms and instructions, with predictably poor results.
To illustrate the thrust of FDA guidelines for pharma on this topic, the Computerized Systems in Drug Establishments document specifically asks whether alarm conditions can be displayed simultaneously in one place so that the operator can respond to more than one alarm at the same time. TiPS netView provides this capability and helps the facility stay compliant.
2. Extensive documentation requirements and regulations
The uniquely diverse pharma product mix and an equally involved manufacturing process for each create an enormous number of alarm points to monitor. Every drug may have completely different formulations, finished product configurations and packaging. As mentioned earlier, the FDA requires all alarm data and operating procedures to be extensively documented along with historical archiving.
This is impossible to make sense of without the right tools. Even if an operator diligently documents and archives all alarm data, no one can feasibly make sense of any of it without access to trends and analytics. This not only threatens to create gaps in the process, but it also makes it harder to improve systems over time.
The LogMate® data processing module, Capture, and its Signal, KB Agent, OPC Client for KB and ACE (Alarm Configuration Expert) modules make these activities a breeze. They can automate data capture, alarm design, response documentation and database importation along with updates to archived data. Notes further help document changes along the way to show MOC compliance. And finally, TiPS LogMate® High Availability protects data so that operators do not lose it in the event of a failover event.
3. A large number of legacy systems
Due to a large amount of M&A activity in pharma over the years, major companies find themselves operating with a number of different process control and building automation systems. For example, Company A acquires the factories of Company B. Company B may have Honeywell Building Automation systems controlling heating, cooling and other environmentals, while Company A uses Johnson Controls systems. It’s common to have disparate systems at play, which creates unique challenges that differ between one facility and another.
The acquired company may have a different process control system (which automates the actual production process) than that of the acquiring company. That same company may have numerous products, each with unique production steps that need to be monitored and alarmed without error.
There is a wide variety of such systems in use, but the acquiring company needs to effectively and correctly integrate acquired systems into their own alarm monitoring system. Otherwise, monitoring would be inefficient and confusing due to duplicative efforts.
As a result, there is a need for alarm management technology that is easy to integrate across diverse systems.
LogMate® is compatible with a large number of control systems, simplifying integration!
4. Ineffective tools for production event investigations
Root cause analysis is a key activity for operators. They need to know exactly what was going on in the facility at the time of a production event. Was there a failure in cooling systems? Was there a power outage? A security breach? Without a tool to gather all of this information in one place, root cause investigations can become a trip down the rabbit hole.
Unfortunately, the lack of full visibility is a common challenge. And it’s not because systems don’t collect data, but rather, the opposite – there is often too much of it to analyze. This leaves operators struggling to prioritize information that’s directly relevant to the ongoing investigation.
With its TRAC module, LogMate® enables full contextual analysis, greatly simplifying root cause investigations by putting all the necessary data at the operator’s fingertips.
5. Difficulty in implementing new practices due to training/workload
In pharmaceutical industry alarm management, a risk analysis or quality control program for a large number of alarms costs a lot of time and resources. Alarm rationalization requires periodic importing and auditing of control system databases. Implementing any required changes takes even more time and attention.
Additionally, many of the same people involved in production must be trained in new processes. It is particularly expensive in pharma because everything must be clearly documented with quality controls built-in. Managers have to weigh ongoing production against upgrades and training requirements.
As a result, alarm monitoring technology must be easy to use and manage to minimize the workload involved. Staff simply can’t afford to spend weeks learning to use a new system while juggling other responsibilities.
Using proven, reliable Microsoft technologies, LogMate® features intuitive point/click navigation and offers speed, stability and ease of adoption to accelerate change and streamline ongoing operations.
A great example is the LogMate® KB Agent module that automates the import of databases and that documents the entire process, saving valuable human resources to be applied elsewhere.
Learn more about LogMate®
As the evolutionary result of TiPS’ 30 years of experience in the field, LogMate® is a full-featured alarm management software, including a suite of products that make managing alarms easy. LogMate® interfaces with existing alarm systems through its Capture module. The module grabs all pharmaceutical industry alarm management data and adds it to a Microsoft SQL Server database, corralling diverse sources to enable a solid alarm management program.
From there, through other modules, alarm data can be analyzed, rationalized, set up for reactions, documented and monitored.
Overall, TiPS LogMate® makes all of the tasks of alarm management simpler and more efficient, and it is particularly suited to address the challenges of pharmaceutical industry alarm management.
To learn more or request a free demonstration, contact us today!