Suppliers of equipment and services must be able to demonstrate their level of compliance to licensed pharma / biotech manufacturers of drugs, intermediates, active pharmaceutical ingredients, and
biological products. Within the culture of Endress+Hauser, we understand that our contribution in helping licensed facilities manufacture, dose and package safe, pure and effective products is an
absolute requirement, simply because the measurement of process critical control points and the subsequent control is a monumental responsibility – morally and legally. This challenge becomes more and more complex every day due to new laws and regulations addressing current Good Manufacturing Practices (cGMP).
Our approach to the life sciences market is predicated on supplying measurement instruments, systems and services that fully comply with the numerous requirements, codes and standards: FDA, ISPE GAMP and ASME-BPE.The new ‘theory of growth’ considers innovation as an essential piece of a process that promotes continuous quality improvement and increases profitability for the licensed facility. Innovation in our measurement instrumentation, systems and services create value in the following areas:
- Support and participation in the User Requirement Specification (URS) phase, allowing for the selection of optimal technologies
- Compliant quality management system
- Team working (and networking) – an absolute key to success
- Products which address specific environmental conditions, process conditions, and hygienic design, while conforming to universal guidelines such as ISPE GAMP4
- The latest technologies to promote predictive features and proactive functions integration for increased productivity and reliability of the manufacturing system
- Diagnostic tools for process critical measuring / control points
- Full documentation with each product, insuring traceability and compliance
- Field-buses and digital networks to a bus monitoring system
- Process Analytical Technologies (PAT) to improve quality, production rates and profitability over the lifecycle of the licensed facility
- Products which are used in the measuring and monitoring of GxP data and process solutions
- Products that are designed specifically to meet or exceed current and future requirements of the life sciences industry
We understand the needs of our customers and the risks that they face. We strive to build mutually beneficial relationships, deliver reliable measurement instrumentation, provide global measurement solution expertise and compliance services. This forms a basis for true partnership between Endress+Hauser and the licensed facility, allowing it to concentrate on its core business – pioneering new research and the subsequent profitable manufacturing of safe products. Is there any better way to create value?