Quality control and approvals
A high level of quality control is one of the fundamental requisites ensuring excellent customer service at Across Barriers GmbH.
The quality control system has been developed in accordance with GLP and GMP guidelines. Accordingly Across Barriers has the following approvals:
- Approval to work with radioactive substances (Security Level 1) (since November 2000)
- GLP Certification (Good Laboratory Practice) (since July 2001)
- Approval according to §§ 64 / 67 AMG (testing of drugs) (since July 2002)
- Approval to work with anaesthetics (since February 2003)
This quality control system includes for example:
- a process control system for recognition, records and management of deviations
- instructions for all process-relevant activities,
- regular check and maintenance of the equipment,
- double-checking of all raw data,
- regular internal and external trainings for all employees.
All our processes are documented in constantly updated handbooks, operational procedures and SOPs. These documents are continually updates, furthermore our quality control system is checked for effectiveness by authority and customer audits on a regular basis.
Across Barriers was successfully audited by the FDA (Food and Drug Administration) in 2009.