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What exactly does "Good Laboratory Practice" (GLP) involve?

What exactly does "Good Laboratory Practice" (GLP) involve?
10/05/2019

"Good Laboratory Practice", or GLP for short, refers to a quality assurance system that is applied during the pre-clinical stage of research and development. Its aim is to test active ingredients under specific environmental conditions and over a defined period of time. This blog article discusses GLP testing in laboratory settings, the correct procedures involved in performing it, and which BINDER products may be useful for achieving GLP standards. Definition of "Good Laboratory Practice" "Good Laboratory Practice" has been in place since 1978, and regulates quality assurance for research and development in the area of medicinal products. It aims to prevent scandals from arising in the medicinal products industry. Since its global launch, the guidelines it contains have enjoyed international recognition. While some GLP measures are implemented on the basis of how large the companies and institutes using them are, there are certain standards that every laboratory area has to comply with.

Approval for areas that are subject to GLP can only be issued once all the necessary tests have been performed and fully documented. For more information on this, see our whitepaper: "Good Laboratory Practice" – What is behind all this?

The principles of "Good Laboratory Practice": Areas and regulations for human resources GLP as a whole regulates the requirements relating to human resources, spatial considerations, and specific units, plus the areas of responsibility that apply during testing. Input from several parties is required during the

testing process, and this means putting together a team made up of the testing manager, testing staff, and quality assurance staff.

The testing manager is responsible for compliance with GLP principles and for the budget.

The testing staff perform the first round of quality assurance procedures, as specified by the test plan.

The quality assurance staff perform the second round of quality assurance procedures and issue final approval for the standard operating procedure.

The content of the operating procedure must describe and define all GLP-related activities. It is something that staff are required to follow, and covers the following aspects:

Testing and reference items Equipment, materials, and reagents Record keeping, reporting, storage, and retrieval (Biological) test systems Quality assurance procedures Procedures for test/analysis methods Computer-supported systems "Interfaces" with internal and external institutions if necessary GLP-compliant testing and approval The steps involved in testing:

The testing manager accepts the testing assignment and draws up a test plan for it. Before the work can start, the quality assurance staff, testing manager, and party who commissioned the assignment must approve and sign the test plan. The test plan includes the test procedure, test methods, and frequency of execution. Its scope may also cover regular quality assurance inspections that monitor compliance with GLP principles. A trial run of the test procedure is performed and the raw data documented. Once the GLP test has then been performed, the testing manager writes a concluding report on the basis of the results. In turn, this report must be approved by the quality assurance staff. The steps involved in approval:

It is not possible for approval to be granted until all the documentation is complete, and has been documented and archived. If anything has not been documented, then the approval process automatically deems it as something that has not been performed. Any missing documentation may result in the product failing to receive approval, incurring significant financial loss and wasted time. How are GLP-related tests usually performed?

GLP-related tests are usually performed in incubators and climate chambers, with the exact process dictated by the requirements of the active ingredient or finished medicinal product that is being developed.

Applications for CO₂ incubators in "Good Laboratory Practice" In-vitro tests require the test conditions to be documented: for example, the temperature, humidity, and CO₂ concentrations in CO₂ incubators. Additionally, standard operating procedures (SOPs) must be used for cleaning and decontaminating CO₂ incubators, calibrating parameters, defining maintenance intervals, and documenting maintenance work.

  1. GLP application case: CO₂ incubators for cells and tissue When working with cells and tissue on the basis of GLP-compliant work processes, it is essential to establish the best possible environment for cultures.

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