Press release
In safe hands with the GLP checklist
The "Good Laboratory Practice" regulatory mandate (GLP for short) was introduced in 1978 after the FDA (U.S. Food and Drug Administration) had already identified significant deficiencies in toxicological studies in the years preceding. The German Chemicals Act was introduced in an effort to ensure that newly approved drugs for human consumption really are safe and minimize any and all risks.The values of transparency, traceability, assignment of responsibilities, and safekeeping are particularly important in this context. The GLP also checks personal, organizational, and spatial requirements before approving a new drug.
To achieve GLP compliance, specific requirements must be met by the laboratory units (e.g., climate chambers) used in the development of the drugs concerned. Maintenance documents and repair documents must be available to consult when a new drug is being tested. To ensure adherence to all rules and regulations on the unit side during the approval process, BINDER has developed a very helpful checklist for its customers. The checklist guides users through the most important points that are relevant to the compliance of their workflows. Questions include, for example: Is a continuous CO2 supply ensured? Are there back-up chambers available for emergencies? Has a cleaning plan or a maintenance plan been drawn up? All of these questions will help users who are working with a simulation chamber and wish to ensure compliance with the quality guidelines of the GLP regulation.
BINDER temperature, climate, and environmental simulation chambers are the centerpieces of modern laboratories. Designed to meet the highest demands in scientific and industrial fields, they enable the accurate simulation of biological, chemical, and physical environmental conditions. With cutting-edge technology and pioneering innovations, BINDER develops products that provide real added value for the customer. We apply our expertise and feel for the requirements of dynamic, day-to-day work in research facilities to support the widest range of projects and processes in an optimum way. After all, our aim is nothing less than making a contribution to the health, quality of life, and safety of people.
Anne Lenze
PR und Event Specialist
BINDER Central Services GmbH & Co. KG
Im Mittleren Ösch 5
D-78532 Tuttlingen
Phone: +49 7462 / 2005 - 632
Fax: +49 7462 / 2005 - 93 632
E-Mail: Anne.Lenze@binder-world.com
www.binder-world.com
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