Do you know what Good Laboratory Practice stands for? In nonclinical animal studies, these requirements spell out the rules that must be followed when studying the safety of drugs. Following GLP rules not only makes sure that researchers treat animals with respect, but it also protects the validity, integrity, and reliability of nonclinical safety data. It is this nonclinical safety data that will be looked at by regulatory agencies when they decide if studies on humans should be done.
Background
The rules that make up have become an important part of making sure that drug research meets quality standards. Even though they've been widely adopted, they were only introduced fairly recently (in my timeline), and it's worth looking at their past. In 1978, the US Food and Drug Administration (FDA) put out "Guidance for Industry Good Laboratory Practices Regulations" because of worries about the quality and scientific accuracy of some nonclinical toxicology studies that were being done in the mid-1970s.
Our most recent Insider's Insight talks about how a scandal involving the business testing unit Industrial Bio-Test Laboratories was found to be a notable event [1]. After the investigations were over, several executives were accused of giving their clients false information, which was then used to show the government that the goods were safe. As it turns out, New Zealand and Denmark had already put out their own GLP rules in 1972, long before the FDA did. The Organization for Economic Co-operation and Development (OECD) adopted these principles in 1992 to promote a more ‘global’ compliance. Both regulations cover a broad range of considerations, including:
As a general rule, GLP rules will apply to most nonclinical studies. That being said, following GLP is not always necessary in the early parts of the pre-clinical phase. Exploratory genotoxicity, mutagenicity, safety pharmacology, and general invitro toxicology studies might not have to follow these rules.
Sponsors often choose to do many of their pre-clinical studies outside of GLP standards in order to save money. This is usually only done when the goal is to characterise preliminary drug safety by figuring out a drug's absorption, distribution, metabolism, and elimination profile. Most of the time, these studies check how well a drug works at first in a variety of settings. Most of the time, the results lead to more research being done in a project where GLP compliance is needed. Standard repeated dose toxicity, genotoxicity, and safety pharmacology studies are examples of studies that need to follow GLP. The way these studies are done needs to be properly documented in Investigator Brochures, Investigational New Drug submissions, and Investigational Medicinal Product Dossiers. Finally, all nonclinical study results that need to be sent with an IND or something similar must be done according to GLP rules.
The Quality Assurance Unit
A key aspect of GLP regulations is the need for a monitoring Quality Assurance Unit (QAU) that is independent of a facility’s operations. GLP Part 58.35 requires QAU’s to monitor the conduct of all studies to “assure management that all facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the regulations.”
The QAU typically audits all nonclinical laboratory GLP studies. The aim of completing these audits is to ensure that the standard operating procedures (SOPs), protocols and GLP requirements have been followed and that the data summarised in the following reports accurately reflects the findings. An QAU audit may include:
Contract research organisations (CROs) can offer subject matter experts in specific processes who can give different operational perspectives. Independent from the Sponsor, CROs can provide an unbiased oversight since their focus is on the ‘service’ provided as opposed to the study findings and ultimate impact on a candidate’s development. In order to ensure compliance, CROs can monitor metrics such as:
Each metric helps define a better understanding of why deviations are occurring and how processes can be improved as well as any potential impact on study findings. Metrics offer a means of reviewing how an organization is currently performing in terms of GLP compliance and overall quality as well as areas where improvements could be made.
Conclusion
In the pharmaceutical industry, GLP regulations provide the framework for assuring the quality and integrity of nonclinical drug safety studies. First introduced in the 1970s, they have become an integral part of nonclinical drug development.
References
When I was younger, the opening lines of the Beatle’s seminal ‘Sgt. Pepper’s Lonely Hearts Club Band’ resonated.
Rational Vaccines (RVx) announces MHRA Innovation Licensing and Access Pathway (ILAP) approval for their live attenuated.
I've been studying medicine for 40 years, and it's beginning to look like something out of science fiction
In the past, Halloween has meant the end of the crop and the start of the dark, cold winter.
Paraskevidekatriaphobia is a phobia of Friday the 13th. Yes, they actually gave it a name.
Since 2013 we have been sharing our understanding on key issues with friends and clients via our Insider’s Insights.
I am continually reminded that I must work toward better relationships with my sons than the one I had with my dad.
Advisory board meetings are often used to address perceived knowledge gaps and build consensus.
Frights create a happy Halloween by providing the thrill of fear in a controlled and safe environment, turning what.
Scientific knowledge should be accessible to all and if you are those communicating science
The clinical stage biotechnology company developing breakthrough therapies for patients suffering with cancer,
The proceedings of the Association for Human Pharmacology in the Pharmaceutical Industry (AHPPI)
We all need heroes - people who can champion our cause - helping the world to understand our rationale
Yes, it’s Star Wars Day again! The Star Wars films base their wow-factor on their adoption of science
Searching the literature can take various forms, ranging from a quick scan of recent publications
Concerns about readiness of the European Medicines Agency’s (EMA) Clinical Trials Information System persist as the.
It was encouraging to see so many partners at the 2017 General Assembly meeting last December
Our team are exploring different and novel ways for young people to enter the pharmaceutical industry.
The UK's world-class human challenge study gives us new information about SARS-CoV-2 cases that were mild in 36 healthy.
We recently encouraged writers (of all kinds) in our recent Insider’s Insight to experiment with large language.
Have you seen our latest Insider's Insight on Case Reports? Once a staple of medical journals,
The largest pharmaceutical companies not surprisingly rely on the largest contract research organizations
Welcome to the seventh issue of the Refractory Asthma Stratification Programme (RASP-UK) newsletter
Investigator sites are very important to clinical studies because they make sure that new drugs are safe and work well.
Congratulations class of 2024. That was all I needed to hear when I stood in your shoes almost 40 years ago. 40 years
Get our latest news and publications
Sign up to our news letterResources
Social
Contact us
Address
Niche Science & Technology
Unit 26 Falstaff House
Bardolph Road
Richmond TW9 2LH
United Kingdom
