Quality policy

The most important basis for our success is the trust between our customers and us. In order to warrant and strengthen the trust our clients place in us, Umforana is committed to comply with good professional practice.

In addition to high-quality analyses and timely processing of orders, our quality management system is the core element to achieve customer satisfaction. Our quality management system, which is continuously developed, based on the principles and guidelines of good manufacturing practice (GMP) according to directive 2003/94/EG and the regulations in accordance with 21 CFR Part 210 and 211.

Principles and objectives of quality management system are set out in the quality management handbook and are binding for all employees.

These include, amongst others:

Providing of precise and traceable analytical results
Timely processing of analytical orders
Training and further education of employees
Internal and external audits
Measures for quality optimization (CAPA)

We have permission to handle narcotics according to §3 of the Narcotics Act (BtMG). Storage in compliance with the requirements according to § 15 of the Narcotics Act (BtMG) is given by a special narcotic safe.

Certificates

Registration as an external laboratory for drug testing with the competent authority, Darmstadt Regional Council (Regierungspräsidium Darmstadt) and GMP-certified.

Last official review by the regional council took place in April 2022.

Download GMP certificate

Listed and inspected as a drug testing laboratory for approvals and stability data collection by the U.S. Food and Drug Administration (FDA).

The conformity of our work with GMP requirements (GMP compliance) is regularly confirmed by audits by our national and international customers.

Participation in proficiency testing studies with INSTAND e.V. (Society for the Promotion of Quality Assurance in Medical Laboratories e.V.).

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