GMP Good Manufacturing Practice
GMP refers to guidelines for quality assurance of the production process and environment when manufacturing drugs and APIs (active pharmaceutical ingredients). In pharmaceutical manufacturing, quality assurance plays a central role because variations in quality can have a direct impact on the health of consumers. A GMP-compliant quality management system ensures product quality and complies with the health authorities’ mandatory requirements for marketing.
Product security according to GMP
Room requirements according to GMP
- Laboratory rooms of classes B and C
- Pressure stages
- Hygienic and smooth surfaces
Monitoring system requirements
- System complies with GMP to monitor all relevant parameters
- Central system to record all parameters
- Easy operation for users
- Clearly arranged and definite alert functions
- Data storage of all quality-relevant data in long-term storage
- Alert / visualisation in the clean room
