Who Needs GLP Training Before a Nonclinical Study ? What Does the FDA Expect?

Introduction

During the process of developing new therapeutic products for human use, potential new treatments are tested for safety and efficacy in a series of phases. After an investigational product has been discovered, it must be tested for safety in the laboratory during nonclinical studies. Good Laboratory Practice (GLP) requirements must be followed for the FDA to consider the data from these studies valid. It is vital that all personnel involved in nonclinical studies receive certified GLP training to ensure the quality and integrity of the research. 

What is GLP, and why is it important for nonclinical studies? 

GLP is a quality management system that forms part of several Good Practice (GxP) guidelines for researching and manufacturing therapeutic products, such as medicines and medical devices. These guidelines form a framework for regulatory bodies around the world to follow—such as the FDA in the United States—and have been translated into local regulatory requirements in many countries. These guidelines ensure the reliability of data supporting regulatory submissions and facilitate international harmonization of standards. 

When an organization applies to the FDA for regulatory approval of a new therapeutic product, much of the safety data collected from nonclinical laboratory studies must have been collected in compliance with the standards and procedures laid out in the FDA’s GLP regulations.  

GLP is crucial in nonclinical studies because it ensures the reliability, validity, and integrity of data generated, which are essential for making informed regulatory decisions about the safety and efficacy of a therapeutic product. 

Which nonclinical studies fall under GLP guidelines? 

Not all nonclinical studies that are conducted during the discovery and development of new treatments fall under GLP requirements. The ones that must comply with FDA GLP regulations include most safety testing, such as: 

• Toxicity profiles, observed no adverse effect levels, teratogenic testing, carcinogenic testing, adverse effects studies and safe levels of use studies. 

Nonclinical studies that don’t fall under GLP requirements include: 

• Basic research, discovery, screening and in vitro studies where safety is not being assessed. 

However, as is often the case with the FDA, the regulations are not always clear. Some in vitro studies around drug interactions and reaction phenotyping are not classified as falling under the remit of GLP, despite their significance in assessing drug safety. In these cases, the FDA recommends that drug interaction studies be conducted “in the spirit of GLP” to assure the quality and integrity of the data. Needless to say, many organizations opt to stick with the same rigorous standards of GLP-compliant studies as a matter of course. 

Who needs GLP training and certification before conducting nonclinical laboratory studies? 

The FDA mandates that all personnel involved in nonclinical laboratory studies subject to Good Laboratory Practice (GLP) regulations must complete formal GLP training. This includes study directors, scientists, technicians, and support staff, not only in pharma and biotech, but also in academia and government labs.

GLP requirements apply to studies involving both approved and investigational products. If the data will be submitted to the FDA to demonstrate safety, quality, or regulatory compliance, certified GLP training is not optional, it’s essential !

What does the FDA expect regarding GLP training frequency and certification for nonclinical studies?  

The FDA expects GLP training to be completed before personnel begin work on any nonclinical study covered by GLP regulations. Training must be certified, documented, and available for review during inspections.

While the FDA does not prescribe a specific frequency for refresher training, it expects that training is kept up to date. Most compliant organizations conduct annual refresher training to ensure ongoing awareness of GLP requirements.

In short:
✔ Initial GLP training is mandatory before any study activity.
✔ Refresher training should be periodic, typically annually.
✔ Certification and documentation are essential for compliance.

What key GLP training components do the FDA expect? 

The FDA expects that certified GLP training ensures the quality, integrity and reliability of data collected during nonclinical laboratory studies. Therefore, training should include: 

✅ GLP’s core principles, including its aim and purpose 
✅ Documentation and record keeping, including GLP training certification, study protocols and SOPs 
✅ Roles and responsibilities, including those of the study director, quality assurance unit and technicians and how studies are managed  
✅ GLP audit procedures, including the role of the quality assurance unit 
✅ Regulatory requirements and compliance, including the capability to respond to noncompliance notifications 
✅ Quality assurance, including the role of the quality assurance unit and the ability to verify data integrity 
✅ Laboratory facilities and equipment requirements 

Key takeaways 

Not all nonclinical studies fall under the remit of FDA GLP requirements, but for those that do, GLP training of all personnel must be conducted before nonclinical studies begin and refreshed periodically. 

• Training should be certified and documented, with records available for FDA inspections. 

• Regular GLP training benefits organizations by ensuring audit-ready documentation, reducing deviations, and minimizing the likelihood of warning notices from the FDA, or worse. 

• The frequency of refresher training is not standardized, but decisions should consider study complexity and personnel experience. 

• Proactive training ensures personnel maintain up-to-date knowledge of GLP requirements, aiding in smoother study execution. 

How GxP Training Supports Your GLP Compliance

At GxP Training, we recommend two certified GLP trainings from our catalog and fully aligned with auditors expectations:

• Introduction to Good Laboratory Practice: Gain a solid foundation in GLP principles and how they apply across the early stages of clinical research. This course introduces key concepts such as Resources, Rules, Characterization, and Quality Assurance, providing essential context for GLP compliance.).

• GLP for Nonclinical Laboratories: Designed for professionals working in nonclinical settings, this course delivers practical, audit-ready knowledge for 21 CFR Part 58 compliance.

All our courses are built to deliver trusted certification, with the following key benefits:

• Self-paced e-learning modules and available 24/7 for 12 months
• Video-led modules followed by an exam — complete with a certified assessment to validate your knowledge
• Earn a unique, traceable certificate that’s fully compliant and audit-ready
• Instantly share your certificate on LinkedIn via a secure, verifiable link
• For teams: unlock enterprise features like compliance reporting, certificate exports, user management, and progress tracking

Start your GLP training today, enroll your team and get certified now!