INTRODUCTION OF A PARTICLE MONITORING SYSTEM IN A PHARMACEUTICAL PRODUCTION FACILITY
The project
QFINITY supported a manufacturer of pharmaceutical products in the implementation and validation of a computerized particle monitoring system.
This project included processes and services in the area of validation planning and execution. It also included the coordination and follow-up of documentation activities at the pharmaceutical company and the manufacturer of the particle monitoring system. The pharmaceutical company could only carry out the implementation in production within a limited time frame. Therefore, an approach had to be found that could be implemented within this time frame and would ensure the necessary conformity with all regulations. This required a detailed analysis of the system manufacturer’s documentation, including site acceptance testing. Based on this analysis, a highly efficient documentation approach could be defined for the implementation and release of the system within the specified time frame.
The goal
The aim of this project was the comprehensive introduction and validation of a particle monitoring system at a manufacturer of pharmaceutical products. Particular emphasis was placed on ensuring that the installation and validation of the system met the strict requirements of the pharmaceutical industry and complied with all relevant regulatory requirements. The new system was to enable continuous monitoring and analysis of particle contamination in order to ensure product quality and the safety of production processes. The implementation was carried out within a clearly defined timeframe to ensure operational continuity and compliance with the planned milestones.
This project served to ensure the highest quality standards, minimize risks and increase efficiency in the production of pharmaceutical products.
Still have questions about validating a particle monitoring system?
What are the critical success factors when implementing a PMS within the given timeframe?
- The following factors are of particular importance when implementing a PMS.
- Support from all relevant stakeholders: Successful implementation is only possible if all stakeholders are clear that the implementation validation must be completed within the given timeframe. In this context, it is imperative to review all documentation created prior to implementation and to evaluate which validation and documentation activities are already being carried out in the production area prior to implementation. The documentation generated by the system manufacturer should be used as far as possible.
What initial obstacles must be expected in such a project?
- An initial obstacle is the different terminology that is established in individual areas and organizations. Open communication and the creation of a universally recognized glossary helps to overcome difficulties in understanding and terminology problems.
- It is also advisable to check and approve the documentation promptly to avoid bottlenecks before the system is implemented in production.
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