Cymapp® for Pharmaceutical
In the pharmaceutical sector, production equipments are critical elements into the production process.
Pharmaceutical companies must deal with a complex landscape of GMP requirements (Good Manufacturing Practice), process validation and quality management imposing extremely high standards for every aspect of the production cycle.
Equipment suppliers must mitigate all potential risks and provide documented evidence of it, in
order to:
- Ensure compliance with regulations, that are increasingly stringent.
- Prevent contamination that could compromise entire production batches.
- Ensure complete traceability of any changes in process parameters.
- Demonstrate during regulatory inspections that all risks have been identified,
evaluated, and properly mitigated.
All advantages
Why Equipment Manufacturers for Pharmaceutical Companies Should Use Cymapp®
- Maps the interrelations between critical process parameters and product quality attributes, highlighting any areas of uncertainty that usually emerge only during production or inspections.
- Identifies potential contamination points and allows risk assessment in accordance with EMA guidelines, avoiding one of the most severe issues in pharmaceutical production machinery.
- Manages one of the most critical moments in the pharmaceutical process life cycle: Change Control (i.e., changes to machinery), evaluating the impact of each modification on all product quality attributes.
- It streamlines the adoption of ICH Q10 requirements and creates a unified language for engineers, production supervisors, and quality managers.
- Creates a comprehensive visual map linking Critical Process Parameters (CPP) with Critical Quality Attributes (CQA), facilitating the demonstration of compliance with FDA, EMA, and ICH Q8/Q9/Q10 guidelines.
- Implements a predictive analytics system that identifies potential deviations during the process design phase, before they can impact product quality.
- It perfectly integrates with existing QMS (Quality Management System), ensuring alignment between machinery risk management and the overall Pharmaceutical Quality System.
Transform Risk Management
The difference between Cymapp® and other similar solutions on the pharmaceutical market is substantial
Machinery Validation
With Cymapp
Integrated Visual Mapping with Reduced Preparation Times
Without Cymapp
Fragmented Documentation, Difficulty in Correlating Process Parameters and Product Quality
Contamination prevention
With Cymapp
Proactive evaluation of contamination risks with optimization of cleaning procedures.
Without Cymapp
Reactive approach to cross-contamination issues with difficulty in demonstrating the adequacy of preventive measures.
Change Control
With Cymapp
Systematic evaluation of the impact of each change with the generation of complete documentation for re-validation.
Without Cymapp
Manual processes for impact assessment with subjective re-evaluation of risks after changes.
Integration with QMS
With Cymapp
Unified system aligned with ICH Q10, which builds a common language across all functions and departments through a holistic view of quality.
Without Cymapp
Information silos not connected between maintenance, production, and quality.