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Quality

Meeting the highest quality standards of our customers and partners is what determines our business activity. From the quality control of pharmaceuticals and medical devices, cosmetics and food to the implementation of all production-related quality assurance measures in the different projects with our customers, the consistent approach to quality management permeates all levels and services of Labor LS.

As a provider of laboratory services, we of course meet all statutory requirements, standards and other regulations in the area of quality control and quality assurance. We receive important impulses for the continuous development of our quality standards from around fifty customers audits each year. The competency and know-how of our highly-qualified employees ensure the consistent implementation of the various quality standards.

Good Manufacturing Practice (GMP and cGMP)

All areas of Labor LS in which pharmaceuticals, raw materials and packaging materials are tested comply with Good Manufacturing Practice and, thus, with the provisions of the German Ordinance on the Production of Pharmaceuticals and Active Substances as well as with those of the EU GMP guidelines. Of course, also the US-American cGMP requirements are met with. Since 1993, Labor LS is regularly inspected and listed as accepted testing laboratory by the US-authority FDA (Food and Drug Administration). In addition, the existing manufacturing authorisation pursuant to Section 13 of the German Medicinal Products Act (AMG) also allows release of pharmaceuticals or certifications by a qualified person according to Annex 16 of the EU GMP guideline.

Good Laboratory Practice (GLP)

In the context of the GLP certification, toxicological and preclinical studies are conducted according to the GLP requirements stipulated in the German Chemicals Act.

Accreditation According to DIN EN ISO 17025

The DIN EN ISO 17025 standard specifies the “General requirements for the competence of testing and calibration laboratories”. The accreditation is in particular intended to prove the qualification and competence of the laboratory for the testing of cosmetics, food and medical devices.

Environmental Management According to DIN 14001

The international environmental management standard ISO 14001 stipulates globally-recognised requirements for an environmental management system. In 1997, Labor L+S AG was one of the first laboratories to be certified according to this standard.

Further Licenses and Qualifications

  • Qualified persons (QPs) pursuant to section 14 of the German Medicinal Products Act (AMG)
  • Experts for providing cross-checks of pharmaceuticals pursuant to Section 65 (4) of the German Medicinal Products Act (AMG)
  • Publicly-appointed and sworn expert for hospital hygiene
  • Accredited as expert for testing of disinfectants according to the German Veterinary Society (DVG) and the German Society for Hygiene and Microbiology (DGHM)
  • Authorisation according to Section 44 of the German Infection Protection Act
  • Authorisation according to Section 3 of the German Narcotics Act
  • Authorisation according to Section 7 of the German Precursor Monitoring Act
  • Approved investigative body pursuant to Section 15 (4) of the German Ordinance on Drinking Water 2001 (TrinkwV)
  • Approved institution of further education for veterinary surgeons specialising in microbiology, and expert pharmacists specialising in pharmaceutical analysis.
  • Genetic engineering system for genetic engineering in accordance with security level 1 of the German Genetic Engineering Act (GenTG)
  • Project manager and responsible persons for the biological safety in accordance with the German Genetic Engineering Act (GenTG)

News

LS opts for a future-oriented corporate structure

Press release dated 23 April 2018


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Events

Mikrobiologie für Nicht-Mikrobiologen: Eintägiger Praxiskurs im Labor

14. Dezember 2018, Mannheim (Concept Heidelberg)


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Low Endotoxin Recovery/Masking

26./27. Februar 2019, Bernried (ECA)


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Contact

Labor LS SE & Co. KG

Mangelsfeld 4, 5, 6
97708 Bad Bocklet-
Großenbrach

Fon: +49 (0)9708/9100-0
Fax: +49 (0)9708/9100-36
E-Mail: service@labor-ls.de

Infobox

In our Infobox, we make additional information on our company, our service portfolio and our QM certification available to you in a download. 

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