Safety Pharmacology

GLP Test Facility

We are a certified German GLP GLP:
In the experimental (non-clinical) research arena, the phrase good laboratory practice or GLP specifically refers to a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical (including pharmaceuticals) safety and efficacy tests. The test results generated in accordance with GLP principles in an OECD member country are accepted in other member countries. An internationally recognized definition of GLP is provided by the Medicines and Healthcare products Regulatory Agency UK:

Good Laboratory Practice (GLP) embodies a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived. These studies are undertaken to generate data by which the hazards and risks to users, consumers and third parties, including the environment, can be assessed for pharmaceuticals (only preclinical studies), agrochemicals, cosmetics, food additives, feed additives and contaminants, novel foods, biocides, detergents etc. GLP helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments ) facility providing hERG patch clamp services according to GLP principles for regulatory submission of compliant data.

Certificate:
Statement of GLP Compliance according to § 19 b Chemikaliengesetz

Quality Assurance:
Each GLP study is inspected by an independent Quality Assurance Unit

Inspection:
Our GLP test facility is approved on a regular base by local authorities according to Directive 88/320/EEC

Archiving:
GLP Study Records and the Final Study Report are archived for 15 years

Personnel:
Our personnel comes with professional background in in vitro safety pharmacology from the pharmaceutical industry