Alarms: Can they be considered as batch release parameters?

by: Gerardo Vece - Executive Consultant @PQE Group

Alarms are an integral part of pharmaceutical processes and, as is often the case, can have an impact on the outcomes of our processes, so the question arises: can alarms be considered as a relevant aspect of batch release? 

When we release a batch, we make sure that everything that may have an impact on the quality of the product is in compliance by conducting a periodic evaluation of the data to determine the limits within which our process can move in order to understand whether it is centered and under control. 

After this brief introduction, we move on to analyze alarm management, starting with what is stated in Annex 1

“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).” 

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What can be gathered from these few lines? 

Certainly, it is understood that alarms must be acknowledged and the frequency with which they occur must be known, emphasizing that critical alarms must be reviewed immediately. Alarms consequently enter into the evaluation of events, which must be reviewed prior to the release of documentation that can be declared in compliance with what is expected. 

On this basis, we can analyze what steps might be necessary to construct an alarm management system that would meet these requirements. 

The key step is to develop an Implementation Plan that describes what will be done and the timing of each activity, as well as containing the list of systems in scope, the approach for prioritizing systems and the plan (Gantt) of activities. 

Following the issuing of the Implementation Plan, the identified activities must be entered into the Quality Management System in order to identify the responsible persons and to allow monitoring of deadlines. 

The next step is to develop an assessment that enables us to: 

  • Fully understand the alarms of each system in scope;
  • Categorize the alarms by criticality;
  • Identify the immediate actions to resolve the alarm;
  • Identify the actions necessary to record both the event and the actions carried out.

After this step, it is necessary to operationalize the assessment by translating what has been identified into activities to be included in the Standard Operating Procedures (SOPs) for the use, maintenance and cleaning of equipment. 

To fulfil the requirement of evaluating alarms by Trend, after the acknowledgement of alarms and the evaluation of their criticality, Trends must be developed based on historical data. For systems that store alarms data, an extraction of the data in a statistically significant number may be performed to generate the Trends and alarm limits. 

On the other hand, for systems that do not have the capacity to store alarms data, it is necessary to collect data by monitoring and recording them, and to build a database for each system in order to develop the Trend once the number of data needed for statistical processing has been collected. 

At this point, we can ask: how do we use all this information to verify the documentation required for the batch release? 

Once the process is complete, the following will be available for each equipment: 
  • List of alarms; 
  • Criticality of alarms; 
  • Standard Operating Procedure (SOP) to manage immediate actions and recording of activities; 
  • Trend with average and upper limit for the frequency with which alarms occur. 

At this point, it is necessary to update the revision flow of the production documentation (Batch Record) to add the verification of alarms against the predetermined limit and... that's it!  

It must be remembered that according to Annex 1, critical alarms must be evaluated immediately when they occur and this means that it must be clearly stated that, when critical alarms occur, the event must be evaluated according to the site Standard Operating Procedures (SOPs) for possible deviation issues. 

In the flow described, many business functions are involved, such as Quality Assurance, production, commissioning and qualification, computer system validation, engineering, maintenance and data integrity, so it is essential to build a team for project Quality Oversight. 

In Conclusion

In conclusion, alarms can be considered batch release parameters because they are an important aspect of pharmaceutical processes that must be acknowledged, evaluated for trends, and taken into consideration when determining the limits within which a process can move. An effective alarm management system includes the development of an implementation plan, assessment of alarms by criticality and immediate action, and the creation of trends based on historical data. These steps help to ensure that alarms are properly managed and taken into consideration when releasing a batch of products. However, it is important to remember that critical alarms must be immediately evaluated according to site SOPs to address any potential deviations. And thus we have created a flow that leads us to use alarms as parameters to be taken into account to release the batch.

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