The general function of an alarm is to warn about any critical condition as life threatening danger or any critical environmental condition like building fire alarm etc. But in pharmaceutical manufacturing facility the requirement of audible alarm in critical equipments has its great importance because the change in temperature can affect the pharmaceutical product quality or it can alter the analysis results.
Since last few years regulatory authorities are also observing the alarming system for the critical equipments. This makes its more importance in pharmaceutical manufacturing environment. FDA has issued different 483s and warning letters due to lack of the alarms. For example A) “There was no data to demonstrate that the chamber alarm would perform as required in the event of a humidity excursion.” B) “Alarms for out-of-temperature specification events of incubators, refrigerators and freezers are audible only in the vicinity of the equipment, and there is no system in place to notify employees of these alarms after hours or over the weekend.”
ISPE guidelines for risk management have the implementation of alarming system in pharmaceutical manufacturing. In the equipments where the rising of temperature can affect the product quality, an alarming system must be implemented. FDA defined the requirement of alarms in “General Principles of Software Validation; Final Guidance for Industry and FDA Staff”
An equipment alarm system should alert the responsible person and engineering by messaging during the non-working hours or weekends to ensure the rectification of the breakdown quickly.
A risk assessment should be done for the criticality of the alarm depending upon its effect on product quality. Failure of each alarm should be assessed for GMP criticality individually. GMP criticality 1 – contains the alarms those failure has a direct impact on the product quality, 2 – alarms those failure has impact on process or system but not directly on product quality while 3 – where alarm failure has no impact on product or system.
In current regulatory environment pharmaceutical companies should include the requirements of alarming system in their user requirement specification of the critical instruments to fulfill the cGMP requirements of the FDA and other regulatory agencies.
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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