Quality and certifications
Consistent quality management permeates all levels and services at Labor LS: from the quality control of pharmaceuticals, medical devices and cosmetics to the implementation of all quality assurance measures accompanying production in the various projects with our customers.
As a laboratory service provider for quality testing, it goes without saying that we comply with all the demands specified by legal requirements, standards and other regulations in the field of quality control and quality assurance. We always keep our quality standards at a "state of the art" level, and we do not view this as a static state at all. Instead, we continually draw on more than seventy customer audits each year to develop new ideas for our quality assurance systems. According to our understanding, a dynamic system can only be lived and developed further with highly qualified employees. For this reason, continuous further training through internal and external impulses, the development and expansion of personal skills and know-how plays a key role in the implementation of quality standards.
Good Manufacturing Practice and thus the requirements of the Pharmaceuticals and Active Ingredient Manufacturing Ordinance as well as the EU GMP Guideline for Good Manufacturing Practice are implemented in all areas of Labor LS in which pharmaceuticals, starting materials and packaging materials are tested. And of course, we also comply with the US cGMP requirements. Labor LS has been regularly inspected by the US Food and Drug Administration (FDA) since 1993 and is listed there as an accepted testing laboratory. In addition, the existing manufacturing permit according to § 13 AMG, also allows releases for the marketing of medicinal products or certifications by a qualified person according to Annex 16 of the EU GMP Guidelines.
- Qualified persons (QPs) according to § 14 Arzneimittelgesetz (German Medicines Act)
- Experts for cross-checks of pharmaceuticals according to § 65 (4) AMG
- Publicly appointed and sworn expert for hospital hygiene
- Approval as an expert for disinfectant tests by the German Veterinary Medicine Society (DVG) and the German Society for Hygiene and Microbiology (DGHM)
- Permit according to § 44 Infection Protection Law
- Permit according to § 3 Narcotics Law
- Permit according to § 7 of the Raw Material Supervision Act
- Approved inspection body according to § 15 (4) TrinkwV 2001 (Drinking Water Ordinance)
- Approved training centre for the further training of veterinary specialists for microbiology and pharmacists for pharmaceutical analytics.
- Genetic engineering plant for genetic engineering work at safety level 1 according to GenTG
- Project manager and officer for biological safety according to GenTG (German Genetic Engineering Act)
All QM documents can be downloaded here.