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.