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Alarm Challenge Test in Pharmaceuticals


It is required to validate the alarms of the pharmaceutical equipment used in product manufacturing and quality control.
The alarm challenge test in pharmaceuticals is very important as it ensures that everything is in working order, hence preventing accidents and other hazards. Safety concerns take the front seat in pharmaceuticals, in large part because the industry deals with the manufacture of medicines consumed by patients. The alarm challenge test in pharmaceuticals is intended to ensure that the systems and processes used to manufacture drugs are in optimal operating mode.

There are varying standards and procedures used to undertake the alarm challenge test in pharmaceuticals depending on the use of the alarm system. In temperature alarm systems, for example, the procedure should comprise one high-velocity alarm assessment and one low-velocity alarm assessment. For each test, the machine or system operator should record the alarm settings according to industry specifications before triggering the preferred alarm event.

Alarm Challenge Test
It is important to authenticate that the alarm system is activated, which may be indicated by an alarm ringer or signal to the entity that provides the alarm services through remote monitoring technology or short messaging service. Once the alarm assessments have been successfully completed, the machine or system operator should proceed to record all information and data on an alarm system assessment sheet. This information should include data on how the alarm system complied or deviated from standard operating procedures.

It is important to consider several issues when undertaking the alarm challenge test in pharmaceuticals. First, it is important to ensure that the processes and systems used in the production of drugs are truly in control and fully validated to minimize the number of alarms that go off during the production phase. Here, professionals working in the industry should note that the alarm challenge test in pharmaceuticals is often used to benchmark the quality of production or manufacturing systems and processes.

Related: Importance of Validation in Pharmaceuticals

Secondly, they should have an in-depth understanding of all automation issues and concerns that may cause problems in the manufacture of drugs. With this understanding, professionals and machine operators can implement the alarm challenge test in pharmaceuticals to, among other things, diagnose the problems affecting the systems and processes, prevent risks and hazards associated with sub-optimal and inefficient processes, and avoid civil and/or criminal litigation. Finally, the alarm challenge test can be used to focus attention and rationalize processes and systems for optimal production of drugs.

Related: How to Write a Validation Protocol?

Professionals working in the drugs industry need to be competent on how to read the results of the alarm challenge test in pharmaceuticals. For instance, if a particular machine or system is not functioning optimally, the sensor readings are abnormally calibrated and in most cases, they are outside of the manufacturer's permitted range. The visual and audible alarms may also not function properly, pointing to a problem that may compromise the quality of the manufactured drugs due to the failure of the alarms to demonstrate the acceptable operation of systems over the standard operating scope as indicated in industry specifications.

Consequently, therefore, it is of immense importance to undertake the alarm challenge test in pharmaceuticals on a routine basis with the view to ensuring efficient production systems and quality drugs. The consequences of not undertaking the alarm challenge test for pharmaceuticals may be very costly for the concerned stakeholders.



Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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