Certified quality management system
Quality Made in Germany 
The quality:
Our company is subject to the quality management system according to DIN EN ISO 9001:2015. Continuous microbiological monitoring ensures the hygiene standard of the production rooms and products. Since 2021, the QM system according to DIN EN ISO 15378:2018 is an additional guarantee for the quality of our products.
DIN EN ISO 15378:
DIN EN ISO 15378 – GMP sets standards for the quality management system of primary packaging for pharmaceuticals. Annex 1 declares packaging as a critical component. In order to guarantee our customers the highest possible quality standard, we have also established a certified and GMP-compliant quality management system according to DIN EN ISO 15378 for the manufacture of pharmaceutical primary packaging.
ISO / GMP:
From granulate to film extrusion, bag production, and cleanroom-compliant packaging of our products, all steps take place in an ISO Class 5 environment.
The particulate and microbiological purity of our production complies with GMP Class B (Good Manufacturing Practice).
In addition, we have special workstations where we carry out sterile activities in an aseptic environment (e.g. pharmaceutical set-packing).
Our GMP quality management is characterized by the following main aspects:
- microbiological monitoring (MiBi)
- batch control (Lot Control)
- risk management (FMEA)
- change management (change control)
- processes for deviations (out of specification)
In addition, we are constantly developing our quality standards.
Ensuring production and delivery – even in exceptional situations
Critical infrastructures:
As part of the critical infrastructure and through our consistent risk management, we are able to maintain our production and delivery processes even in exceptional situations.
KRITIS, or critical infrastructures, refers to sectors and facilities whose failure or impairment could have a significant impact on public safety, health, the economy or the functioning of society. These include energy supply, water supply, healthcare, information technology and telecommunications. In order to protect these key infrastructures from threats, the federal government has introduced appropriate security measures and regulations in many countries. The aim is to ensure the resilience and resistance of these critical areas in order to maintain the stability of society.
In close cooperation with our customers, we develop concepts and mechanisms to ensure first-class supply and to remain able to deliver continuously.
KWP GmbH, based in 63584 Gründau, is classified as a system-relevant facility of the critical infrastructure (KRITIS-Extern) according to the decision of March 10, 2021 by the Hessian Ministry for Social Affairs and Integration (HSMI, Head of Department III/2 Medical Devices, Occupational Medicine, Radiation Protection).
