A focus on alarm management: how accurate alarm assessment documents can ensure a proper alarm management process

by Federico Salomoni, Pharma Validation Specialist @PQE Group

In the complex and strictly regulated world of pharmaceutical manufacturing, precision, safety, and quality are sovereign. A crucial element alongside the entire production process is alarm management. A competent alarm management process ensures that the manufacturing processes are performed with uncompromised product quality and safety. 

Considering the regulatory framework, a crucial role is recognized for alarm management as it ensures that processes remain within predefined critical parameters. Annex 1 of the EU GMP guidelines underscores, for example, the importance of alarm management in pharmaceutical manufacturing, emphasizing the need for an effective system to prevent deviations and maintain product quality. 21 CFR Part 11 addresses the use of electronic records and electronic signatures, which are closely related to alarm management, especially in the context of data integrity and compliance. 

The first operational step for a new alarm management flow is the execution of alarm assessments. Of course, before the execution of alarm assessments, an implementation plan for alarm management must be defined, that lists the consequent steps to obtain, as a result, a proper alarm management workflow from assessment to alarm review for batch release, and the timings for each step of the process. The defined plan must also include the requirements for alarm assessment execution, results, downstream steps and timings, regarding both existing and newly installed equipment.

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The main purpose for the alarm assessment process is to characterize equipment alarms with the proper criticality, and to define a standardized method for the alarm classification process. Many factors contribute to criticality attribution, but certainly, the possible impact on Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) is in the top tier. The occurrence of an alarm with an impact on these latter elements will of course require dedicated attention and management. 



To perform the alarms assessment of equipment, it is required to analyze the list of alarms. The alarm list can be found in different documents, for example in the user manual or in an equipment specification document, in which alarms may have already been classified and associated: the more information gathered from the available documentation, the better. 

Once the alarms list is ready, the classification phase can start. It is recommended to define a template for the alarm assessment documents that will be generated; this allows creating a standard to follow, reducing the risk of errors and discrepancies. The attribution of a classification should take into account many factors; first, the CPPs and CQAs involved and the possible related impact, as already said, but many others. For example, some consequences of the alarm occurrence include: 

  • The ability of the equipment to manage the alarm automatically, and to avoid or resolve a possible CPP/CQA impact; 
  • Equipment shut-down after alarm occurrence; 
  • The requirement of manual intervention to prevent an impact on CPPs and/or CQAs; 
  • The requirement of acknowledgement only. 

These are examples of elements useful/relevant to evaluate the criticality of an alarm. Another layer of the classification can concern how the alarm occurs; for example, the management of the alarms can be differentiated if the alarm occurrence is expected or unexpected. There can be alarms (e.g., Door Open) that if expected, do not require particular supervision, such as if the activation is the consequence of an action voluntarily performed.  



Certainly, the alarms assessment is not complete until further steps are defined, particularly regarding the actions to be performed after alarm occurrence. The definition of actions to manage alarm condition can be, for example, distinguished in Immediate Actions – to manage alarm occurrence and allow its reset – and in Late or Post-Execution Actions, such as how to record alarm occurrence and how to manage the risk of a CPP/CQA impact on the production activity. 

A natural consequence of the definition of all these requirements is the need to update Standard Operating Procedures (SOPs) to translate these new approaches and alarm management steps into operation. The update should include all the procedures involved along the alarm management process, from those regulating how alarms are classified to those regarding the conduction of the equipment.  



The process of alarm assessment is crucial to assure that alarms occurrences are managed properly, in order to avoid impact on CPPs/CQAs, and therefore on product quality. It is necessary to define a method (preferably standardized) for the systematic execution of alarm assessment as the first operational step to implement a new and more efficient, trustworthy and replicable alarm management process. 

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