"Good Laboratory Practice"March 2016
Maximum drug safety thanks to GLP
"Good Laboratory Practice", or GLP for short, is a quality assurance system that encompasses all organizational structures and the sequences of analyses and tests for the approval of drugs. But what exactly do the GLP guidelines actually cover?
In every phase of drug development, drug safety is of paramount importance for the pharmaceutical company conducting the research. Drugs are subject to stringent safety standards. Before they are approved for clinical trials, they are first subject to a strictly regulated development process that is monitored by the authorities. The safety of an active ingredient must first be proven in pre-clinical trials. These are subject to the "Good Laboratory Practice" (GLP) regulations. But what does GLP actually mean? Perhaps the best-known example of errors in toxicological studies is the thalidomide scandal, the extent of which today is still not entirely clear.
Worldwide quality assurance system
For this reason, a worldwide quality assurance system had to be created that makes it possible to track every individual stage in a non-clinical safety test. Non-clinical tests includes all laboratory studies not conducted on humans. In addition to drugs, GLP also covers substances in pesticides, chemicals, and cosmetics, for example. Alongside the collection of approval-relevant safety data, GLP guidelines also encompass all organizational structures and the sequences of analyses and tests for the approval of drugs. The aim of these guidelines is to prove if substances harmless to people and the environment. As well as tests for the approval and registration of drugs, stability testing is also carried out, which is part of continually monitoring the quality of drugs. The aim of these tests is to prove that a pharmaceutical product has the necessary stability or quality throughout the proven shelf-life. The KBF-series constant climate chambers from BINDER are particularly suitable for carrying out drug tests thanks to their large temperature and humidity range. The constant climate chambers are the specialist equipment of choice when it comes to precise stability tests under climate conditions that are kept constant for an extended period. With its interior volume of 1020 liters, the new constant climate chamber is specially equipped for the efficient storage of physically large samples or large test specimen quantities thanks to its cube-like interior. The innovative APT.line preheating chamber technology guarantees a high level of temperature accuracy – even under full load – as well as outstanding temperature variation. What's more, it also provides reliable protection against condensation. And as the inner chamber and all fixtures are made of stainless steel, there is no risk of electrochemical corrosion.
Testing according to ICH guidelines
Constant climate chambers not only fulfill the required climatic conditions for meeting international standards according to the ICH guidelines (International Conference on Harmonisation), but also offer a far wider climate range. In climate mode, temperatures range from 10°C to 70°C; the relative humidity range can be adjusted from 10% RH to 80% RH. The KBF P-series constant climate chamber is available with an illumination device in accordance with ICH-Q1B, option 2. With this device, pharmaceutical products are exposed to defined light quantities under constant climatic conditions. Detailed information about GLP guidelines is available in our GLP White Paper.