Nowadays we become more and more aware that animals are not „just meal”. They are intelligent beings, with emotions and feelings. We try to protect their rights and avoid exploiting them. But being an inventor of a new drug, a new therapeutic molecule, would you take the risk of giving it to a human volunteer only after testing it in vitro on cell lines or tissue cultures? Without the knowledge of how this drug behaves in a living organism as a whole? Probably not, and therefore we still need at least some animal testing in drug development.
To limit the non-clinical studies to the minimum, we need to make sure that the experiments are conducted in a way that assures their high quality – and that is the main goal of the rules of Good Laboratory Practice (GLP). The first draft of GLP principles was developed by the Food and Drug Administration (FDA), nearly 50 years ago, as a result of controls in several laboratories testing the toxicity of chemicals, which revealed major malpractices. Later on, in 1981, the Organisation for Economic Co-operation and Development (OECD) created international standards of GLP.
GLP is a system for ensuring the quality and credibility of the obtained research results, from the moment of their planning, to the proper storage of source data and reports, so that it is possible to trace the course of the research or its complete reconstruction. The basic aspects that the GLP system guidelines addresses are:
The four pillars of GLP are: reliability, repeatability, verifiability, and recognition by the scientific society all over the world. Thanks to the GLP system, it is possible to standardize research in various laboratories around the world, which makes the results of the studies acceptable by international organizations.
The GLP rules should be taken into account in non-clinical studies in the field of human and environmental safety and health, in particular in the testing of pharmaceutical substances and chemical preparations. This includes the pivotal non-clinical studies assessing the safety of new molecules. But GLP principles are also important in clinical trials – the laboratories performing the analysis of clinical study samples, although they do not need to be GLP certified, should act in accordance with GLP rules.
Just a handful of pharmaceutical companies have the know-how, equipment and resource to run the non-clinical studies and clinical trials themselves. For the majority, it is the service, which is outsourced. So how to make sure that the company offering the services meets the required criteria? The best way to do this is through the audits.
At SciencePharma, we offer, among others, quality systems audits for compliance with GLP.
The audit may be performed prior to contracting the study, as a mean of supplier qualification. Its purpose would then be to verify the structure and organization of the research facility, the compliance of the procedures with the GLP rules, the qualifications of the personnel of the facility and the quality assurance of the generated results.
We can also audit a particular study. In such case, the audit is primarily aimed at verifying the integrity of the study results and checking whether the study was carried out in accordance with the previously agreed plan and the facility’s procedures.
The audits can be executed remotely or on site, with the on-site visits giving surely more insight.
One could wonder – if there is the GLP certification, is it necessary to audit the laboratories, which perform the tests? The answer, of course, is yes. As mentioned earlier, not all studies conducted during the drug development need to be done in GLP-certified facilities, but it is expected that all of them are done in the spirit of GLP. Our experienced team of auditors can make sure of that for you.
The GLP auditors at SciencePharma are experienced in non-clinical in vitro and in vivo studies, as well as the analytics of samples from clinical trials. We have experience working in the GLP environment. Even if the facility is not GLP-certified, we make sure that the following aspects are in accordance with the GLP guidelines:
And finally, we issue a recommendation if the laboratory concerned could be contracted with the study that the sponsor plans to perform.
If you want to make sure that the facility you selected for your study will comply with the GLP rules and deliver reliable, repeatable and verifiable results, recognized by Competent Authorities around the world, consider the GLP audit.