Checklist to assist quality assurance

July 2018 BINDER thinks ahead for users

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.