Can Alarms Be Batch-Release Parameters? A European Perspective

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Alarms are integral to pharmaceutical processes and even can affect process outcomes. That raises a question: Are alarms a relevant aspect of batch release? Before our company releases a batch, we evaluate process data to ensure that everything that can affect product quality complies with regulations. Understanding whether our manufacturing process is centered and under control enables us to determine the limits within which it can shift.

We analyze alarm management by following Annex 1 of European good manufacturing practice (GMP) guidelines (1). It states that “process and equipment alarm events should be acknowledged and evaluated for trends. The frequency at which alarms are assessed should be based on their criticality (with critical alarms reviewed immediately).”
Certainly, staff members must acknowledge alarm events and understand the frequency with which they occur. When an alarm is triggered, it enters the evaluation of events, which workers must review before releasing documentation for regulatory compliance. Knowing such requirements, we can analyze the necessary steps to construct a compliant alarm-management system.

The first step is to develop an implementation plan that describes necessary tasks and timing for each activity. The plan should contain a list of relevant systems, an approach for prioritizing systems, and a Gantt chart to log activities. After enacting the plan, operators must enter denoted activities into the company's quality management system to identify responsible persons and monitor deadlines.

The next step is to develop an assessment that enables staff to understand the alarms of each system in scope, categorize them by criticality, identify immediate actions to resolve them, and find methods for recording both events and associated actions. This assessment should be operationalized such that learnings and identified actions can be incorporated into standard operating procedures (SOPs) for equipment use, maintenance, and cleaning.

After acknowledging alarms and evaluating their criticality, trends must be recorded based on historical data. If a statistically significant amount of data is available, then workers can extract information from systems that store alarm data and use that information to generate trends and alarm limits. On the other hand, if a company’s systems cannot store alarm data, then operators must collect and monitor alarms manually. A database should be built for each set of equipment to help identify trends once the amount of data collected is sufficient for statistical processing. Finally, staff should update the revision flow in a batch's record to add verification of alarms against the predetermined limit. By completing the steps outlined above, you will have

• a complete list of your alarms
• an understanding of the criticality of each alarm
• an SOP to manage immediate actions and record activities
• trend data with averages and upper limits for the frequency with which alarms occur.

According to Annex 1, critical alarms must be evaluated immediately and according to your site’s SOPs so that operators can identify possible deviation issues (1). Many business functions are involved in that workflow, such as those for quality assurance, production, commissioning and qualification, computer system validation, engineering, maintenance, and data integrity. With so many people involved in the process, it is essential to follow the right steps and prepare your team to provide quality oversight.

1 Annex 1: Manufacture of Sterile Medicinal Products. The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use. European Commission: Brussels, Belgium, 2022;

Gerardo Vece is good manufacturing practice (GMP) compliance executive consultant and associate partner, and Gaurav Walia is senior global director of business development and principal of computer system validation, DI consultant, and senior associate partner, both at PQE Group, Località Prulli 103/c 50066 Reggello, Florence, Italy; [email protected].

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