4 PILLARS OF THE QM SYSTEM OF TOPMEDICARE GMBH

Quality management (QM) is the basis for reliable processes and results. Our QM system in accordance with the EU GMP guidelines covers the entire process chain of pharmaceutical production and thus makes an important contribution to patient safety and profitability.

These are the pillars of our QM system:

1. Risk management: Applied know-how for your process and product safety
Quality is no coincidence. A critical risk assessment of all processes is the prerequisite for the design of our processes and lays the foundation for the consistently high quality of our products. In doing so, we use the expertise of all those involved and develop comprehensive concepts that you can rely on.

2. Continuous improvement management: optimization and sustainability
Minimizing errors, increasing efficiency and customer satisfaction are our top priorities. This is the motivation for us to continuously improve all company processes and to continuously check for potential for improvement. An integral part of our improvement management are the CAPA and change control systems.

3. Quality documentation: From international regulations to concepts for product-specific implementation
We are always up to date and continuously monitor the applicable national and international regulations. Actively and conceptually, we implement new requirements and thus maintain our consistently high quality level according to current standards.

4. Qualification and Validation: Documented, traceable reliability
Safety and quality of all processes are our top priority. We guarantee this through the qualification of our plants and the validation of our processes. In detail, we carry out the following measures:
•    Equipment and facility qualification
•    Supplier qualification
•    Operator qualification and training
•    Process validation
•    Method validation
•    Cleaning validation