Quality
We are regularly audited by our customers and inspected by the responsible regional authority (Landesamt für Gesundheit und Soziales, Berlin [State Office for Health and Social Affairs]). Subsequent to their last inspection in June 2023 the regional authority issued new GMP-certificates regarding manufacture as well as testing of APIs and drug products for human and/or veterinary use.
Our last inspection by the US Food and Drug Administration (FDA) successfully took place in June 2017.
Quality
The quality of our services is guaranteed by the skills and motivation of our employees as well as our in-house GMP culture. Our quality management system provides the basis for this.
We are regularly audited by our customers and inspected by the responsible
regional authority (Landesamt für Gesundheit und Soziales, Berlin [State
Office for Health and Social Affairs]). Subsequent to their last inspection
in August 2020 the regional authority issued new GMP-certificates regarding
manufacture of currently nine APIs for human and/or veterinary use as well
as testing of APIs and drug products.
Our last inspection by the US Food and Drug Administration (FDA) successfully
took place in June 2017.
Quality statement
Chemisch-pharmazeutisches Labor, Rolf Sachse GmbH (CPL) provides products and services in compliance with current GMP requirements for active pharmaceutical ingredients (APIs). The aim is to ensure that all products are fit for their intended use and comply with the ICH guidelines and other drug regulations.
CPL has implemented a quality assurance system which forms
the basis for successfully achieving the quality standards
required by international laws and guidelines and regulatory
authorities. CPL's QA and QC units are responsible for monitoring
and directing the quality of CPL's products and services.
All employees are committed to and qualified for performing
high quality work according to approved internal procedures
and globally accepted standards.
CPL is continuously improving the effectiveness of its quality
system through monitoring work practices, process improvements,
employee involvement as well as motivation and training.
CPL's management is committed to providing the directions,
means and resources to implement the quality policy outlined in
the present statement.
Dr. Andreas Sachse
Managing Director
