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Certifications
Certifications
The consistent implementation of a certified quality management system in line with both pharmaceutical requirements, which are closely linked to compliance with GMP guidelines for good manufacturing practice, and regulatory requirements for medical devices, means that we can guarantee our processes are always being carried out under controlled and reproducible conditions.
Röchling Medical has numerous certificates for management systems and products and is constantly working on new developments and their associated certification.
All of our actions are marked by a distinct focus on sustainability. This includes a profound awareness of environmental and energy related matters portrayed by the implementation of certified management systems that comply with ISO 14001 – Environmental management and ISO 50001 – Energy management. It goes without saying that we actively comply with health and safety at work requirements.
Strictly controlled environmental conditions are required in the manufacture of products for the pharmaceutical, life science and diagnostics sectors. All our locations are able to produce items in cleanroom conditions.
The following table gives on overview of our locations and their certifications:
| Certification | Area | Neuhaus Germany | Brensbach Germany | Waldachtal Germany | Rochester USA | Lancaster USA | Suzhou China |
| ISO 9001 | Quality Management Systems – Requirements | — | — | X | X | — | X |
| ISO 15378 | Primary packaging materials for medicinal products – Particular requirements for the application of ISO 9001, with reference to good manufacturing practice (GMP) | X | X | — | — | — | — |
| ISO 13485 | Medical Devices – Quality management systems – Requirements for regulatory purposes | X | X | X | X | X | X |
| ISO 50001 | Energy management systems – Requirements with guidance for use | X | X | X | — | — | — |
| ISO 14001 | Environmental management systems – Requirements with guidance for use | X | X | — | — | — | — |
| ISO 45001 | Occupational health and safety management system | X | X | — | — | — | — |
| ISO 8317 | Child Resistant Packaging – Requirements and testing procedures for reclosable packages | X | — | — | — | — | — |
| ISCC-PLUS | Compliance with the requirements of the certification system ISCC PLUS (International Sustainability and Carbon Certification) - certified materials for circular and bio-based packaging solutions | X | X | X | — | — | — |
| Drug Master Files | (for selected products) | X | — | — | — | — | — |
| FDA registered | — | X | X | X | X | — |
Documents: Certifications and Approvals
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