To GLP or not to GLP? That is the question...
Good Laboratory Practices (GLP) are federal regulations that require implementation of a robust quality management system to ensure the validity, integrity and reliability of non-clinical safety data submitted for regulatory evaluation and approval.
US Food and Drug Administration (FDA) GLP regulations (21 CFR parts 11 and part 58) were first issued by the US in 19781, and, at that time, safety data was mainly obtained from in vivo animal test systems.
Since then, researchers have continued to develop alternative ways to assess drug safety, and now, GLP regulations can be applied to all non-clinical laboratory safety studies, including in vitro and ex vivo test systems.
In short, GLP-compliant studies require documentation (eg standard operating procedures) and are overseen by quality assurance units that perform process-, facility- and study-based inspections. In this article, we provide an overview of which studies require GLP compliance, which do not, and why in some cases the choice is unclear.
Understanding the details of your prospective contract research organisation’s (CRO) GLP-compliant and non-GLP compliant study conduct is key. Once you know exactly what to expect, you can select the level of study you need to achieve your project’s objectives – and possibly, depending upon the CRO, save time and funds by choosing non-GLP.
Which studies require GLP?
With formal regulations in place, you’d think the answer to this question would be simple. It is, and it isn’t.
In summary, the FDA guidelines for GLP compliance are as follows:
1. Evidence that their products are safe in research and/or marketing applications (21 CFR 58.1) must be submitted by sponsors of nonclinical laboratory studies to support the safety of:
- Food and colour additives
- Animal food additives
- Animal drugs
- Human drugs and biological products
- Medical devices for human use
- Electronic products
2. Non-clinical laboratory studies that must comply with FDA GLP regulations include:
- Toxicity profiles
- Observed no adverse effect levels
- Risks of clinical studies involving humans or animals
- Potential teratogenic, carcinogenic or other adverse effects
- Safe levels of use
3. Compliance with GLP regulations is NOT required for these studies:
- Basic research
- Any other in vitro studies in which the safety of the product is not being assessed...
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