The term systems engineering (German translation: Systemtechnik) in the context of Good Manufacturing Practice (GMP) covers a wide range of systems and equipment used in pharmaceutical production to ensure efficient and safe operation in drug manufacturing.

These systems include the following components, among others:

• Heating, ventilation and air conditioning (HVAC): Heating, ventilation and air conditioning (HVAC; translation into German: Heizung, Lüftung und Klimatechnik) provides controlled environment conditions (temperature, humidity, air purity) in order to maintain product quality and prevent contamination.
• Water supply and water treatment systems: These include water treatment systems (purified water, water for injections), which play a crucial role in the manufacture of drugs.
• Compressed air and gas systems: Designed to supply sterile air or gases for use in manufacturing processes.
• Waste management systems: Includes the treatment and disposal of solid and liquid waste in accordance with environmental standards and GMP.
• Power supply and emergency power supply systems: Ensure the continuity of production processes and the preservation of critical data in the event of power outages.
• Automated control systems: Control of production processes, ensuring accuracy, repeatability and the documentation of processes using programmable logic controllers (PLC; German: speicherprogrammierbare Steuerung), among other things.
• Cleaning and sterilization systems: Includes autoclaves, drying cabinets, CIP (cleaning in place) and SIP (sterilization in place) systems to ensure the sterility of equipment and production facilities.
• Monitoring and analysis systems: Developed for the continuous monitoring of production processes and product quality.

All systems engineering components must be designed, installed, qualified and maintained in accordance with GMP standards to ensure their reliable and safe operation. Particular attention is paid to quality, safety and documentation in order to ensure that the manufacturing processes and end products comply with the specified legal requirements.

As experts with longstanding experience, we are more than happy to interpret during your GMP inspection by foreign regulatory authorities — contact us by email or phone for a quote!