In practice, alarms function primarily to warn facilities of unsafe conditions by sending alerts and setting attributes to identify these alert locations. Operators can then act upon and fix the issue so that normal operations can continue. Alarms have been developed especially for the pharmaceutical industry, a highly regulated environment, as it needs to satisfy FDA guidelines. As such, it is critical to have reliable alarm management in this industry to ensure sufficient visibility on alarm systems and problems.
FDA Guidelines Bring Both Protection and Unique Challenges
The pharmaceutical industry has strict regulations due to FDA (Food and Drug Administration) guidelines. As manufacturers and distributors of drugs to medical facilities, this industry greatly affects patient health and safety. In fact, the pharmaceutical industry in the USA manufactures about 30-40% of the world’s drugs. To help standardize the management of these crucial facilities, the FDA has provided guidelines for computerized systems in pharmaceutical establishments that manufacture drugs and provides software-related suggestions for installing an alarm management system.
The FDA requires documentation of all alarm functions:
- All alarm triggers that connect different components like the formulation development unit, powder-blending unit and milling.
- All alarm threshold parameters and response procedures.
- How alarms are recorded, whether in batch records, logs or by the control system (which also includes maintaining historical records).
- All maintenance procedures of the alarm devices as a standard operating procedure for the operations team.
Additionally, according to the FDA, alarm management systems must:
- Capture all data from the alarm devices.
- Provide an exceptionally reliable interface for monitoring and acting upon the captured data.
- Properly establish all documentation so there is no error when an operator receives an alarm and acts upon it. (The operator does not have to respond to every alarm message but must respond to critical ones.)
- Provide an outstanding interface for monitoring all installed alarm devices. A visual display monitor must also be added to the interface for a bigger-picture look.
Unique Requirements for Alarm Management in the Pharmaceutical Industry
Alarm devices capture data and transmit it to an alarm management system, which analyzes it to help resolve critical failures. This process includes the need to prioritize alarms so that engineers can quickly understand the urgency of the situation and act accordingly.
The pharmaceutical industry does not have specific guidelines for alarm priority. However, as a rule of thumb, operators should assess all alarm devices for quality control before introducing them into the manufacturing unit. The focus on quality control helps avoid critical alarm and process failures and helps manage non-critical alarms so they do not impact the operations of the pharmaceutical unit.
This industry uses the following categories for alarm system risk assessments:
- Alarm failures that have a direct impact on product quality.
- Alarm failures that have an impact on processes and systems but not directly on product quality.
- Alarm failures that do not have an impact on systems or product quality.
Mitigating these failure categories will help avoid bad product quality, provide better process and system controls, and avoid system/alarm device malfunctions. Besides risk assessments, alarms are analyzed to detect freezer warning alarms as well as high-temperature alarms. This is necessary so that alarms function efficiently to maintain proper temperature control for production. Pharmaceutical companies will also benefit from an alarm management system that effectively generates alarm signals to maintain process control flows, alarm device monitoring and safety with the proper documentation of procedures.
How LogMate® Can Help
Pharmaceutical facilities need a robust alarm system to meet FDA guidelines. Historically, alarm management systems were focused on post-failure crisis rather than being online in real time to reduce the downtime of quality drug production.
TiPS Incorporated offers LogMate®, an exceptionally reliable software that makes managing alarms in the pharmaceutical industry easy. Supported by cGMP (current good manufacturing practices), LogMate® ensures that all the alarm devices located around the facility have all procedures in place for operations according to FDA regulations. LogMate® also has an interface for operators to monitor each activity on alarm devices either on its screen or on a user-display screen for bigger and better resolution.