Life science companies must adhere to the FDA’s Good Manufacturing Practices (GMP) in manufacturing and storage of the product within their manufacturing facility. For example, GMP compliance is required for a bioreactor process and for any product storage in a freezer room. GMP ensures that each step of the manufacturing process is conducted under controlled conditions, with appropriate documentation, data records and quality checks at each stage.
To ensure quality and GMP compliance, manufacturers rely on alarm notification systems. These systems provide proof of successful campaigns by ensuring there are no critical alarms related to critical quality data. That’s why an alarm notification system is an important tool for quality assurance.
Alarm notification systems are set up to inform an operator of any potential deviations from established parameters. Therefore, it is essential that alarm notification systems be validated and must:
- support multiple low and high threshold values,
- notify appropriate personnel when sensor readings exceed threshold values,
- have configurable delays before alarm generation and notification, and
- be able to communicate alarm states by text, email or phone.
Alarm notification framework and design
Alarm notification for GMP compliance works best when deployed with a risk-based approach that groups alarms depending on how they might affect the quality of the product. Deviations from alerts do not all have the same importance. The Good Automated Manufacturing Practice (GAMP) framework from the International Society for Pharmaceutical Engineering (ISPE) is an organized, risk-based approach to designing and implementing alarm notification systems that prioritizes important issues first. This approach recognizes that not every alarm is the same and they should be ranked according to how they might affect the quality of the final product.
This risk-based framework offers an organized method for creating and putting into place an alarm notification system that:
- Addresses critical issues first: Prioritize alerts depending on their potential influence on product quality. This ensures that serious concerns are addressed immediately.
- Reduces errors and omissions: An alarm notification system should function as an easy-to-read instruction handbook to help operators minimize the possibility of overlooking important signals due to overload.
- Improves documentation: One of the most important requirements for GMP compliance is audit trail documentation, which is automatically maintained by a well-designed alarm system. The history of alarms, acknowledgements and any corrective measures taken should all be included.
Beyond risk assessment, the design of the alarm notification system itself plays a crucial role in GMP compliance for manufacturing processes. Following are some key considerations:
- Clarity and conciseness: Alert messages should identify the precise problem, where it stands in the manufacturing process and the suggested next step. Communications should be easy to read, succinct and clear.
- Prioritization: To attract quick attention, critical alarms should have recognizable alerting techniques, such as beeping lights and audio alerts. Notifications with a lesser priority can use visual alerts or lower priority notifications.
- Redundancy: To ensure that important alarms are not silenced in the event of equipment failure or power outages, implement a redundant notification system that combines visible, audio, text or pager messages.
- Manufacturing specificity: Alarms should be configurable based on the specific manufacturing step/phase. This ensures notifications are relevant to the current stage of production and minimizes false positives.
- Acknowledgement and documentation: A designated person must acknowledge each alarm that is triggered. The moment of acknowledgment, any corrective measures taken and the corresponding batch number should all be recorded by the system. This trail of documentation shows how you responded to GMP audits.
The need for continuous improvement
Alarm management is a dynamic process. Examine and evaluate your alarm history on a regular basis. Determine which low-priority alarms are common enough to cause alarm fatigue and desensitize staff members. Continuously evaluate ways to improve your risk assessment and modify your notification procedures as necessary. This ongoing enhancement lowers the possibility of missing important notifications and promotes a culture of GMP compliance.
Manufacturers can turn their alarm notification systems from a source of annoyance to an effective instrument for guaranteeing GMP compliance in manufacturing procedures by putting these techniques into practice. Efficient alarm handling ensures reliable product quality, streamlines processes and leads to the safe and superior delivery of pharmaceuticals.
Because less is usually more, be sure to develop concise, useful alerts that are unique to your manufacturing operations, and keep an eye out for alarm fatigue to ensure you are operating in a state of control that promotes strong GMP compliance.
Danny Haskell is president at NeoMatrix, a certified member of the Control System Integrators Association (CSIA). For more information about NeoMatrix, Inc., visit its profile on the Industrial Automation Exchange.
