FDA GLP Compliance
Experienced FDA Counsel for Good Laboratory Practice (GLP) Compliance for Nonclinical Laboratory Studies
FDA GLP Compliance Team Lead
Contact Nick 
FDA GLP Compliance Team Lead
Former Senior DOJ Trial Attorney
The U.S. Food and Drug Administration (FDA) regulates nonclinical laboratory studies through the enforcement of its Good Laboratory Practice (GLP) regulations. Facilities conducting (or preparing to conduct) a nonclinical laboratory study must ensure strict compliance with the GLP regulations as their standard operating procedures, as noncompliance can lead to FDA enforcement actions in some cases.
Our lawyers and consultants assist laboratories with all aspects of FDA GLP compliance. As our team includes a former FDA Compliance Director, former FDA investigator, and former Special Agent with the FDA’s Office of Criminal Investigations, we are intimately familiar not only with the FDA’s rules and regulations, but also the risks and consequences of noncompliance. We rely on these insights to provide straightforward, practical, and comprehensive GLP compliance advice to our clients.
What Lab Execs Need to Know About the FDA’s GLP Regulations for Nonclinical Laboratory Studies
Compliance with the FDA’s GLP regulations is mandatory when conducting nonclinical laboratory studies, which are experiments in which test articles are studied in test systems like animals, plants, or microorganisms under labratory conditions. With this in mind, here is an overview of what lab execs need to know about FDA GLP compliance:
1. The FDA’s GLP Regulations Are Intended to Produce “Well-Controlled Studies”
A presentation prepared by the FDA’s Division of New Drug Study Integrity (DNDSI) and Office of Study Integrity and Surveillance (OSIS) describes the GLP regulations as, “a framework for conducting well-controlled studies.” The GLP regulations seek to produce well-controlled studies through three primary means:
- Assuring Data Quality and Integrity – The GLP regulations include various provisions intended to assure the quality and integrity of all data generated during nonclinical laboratory studies. Data quality and integrity are essential to effective research; and, while many laboratories go to great lengths to ensure the value of their data as a matter of course, laboratories must also ensure that they are taking the specific steps required to establish (and demonstrate) FDA GLP compliance.
- Facilitating Study Reconstruction – The GLP regulations also include several provisions intended to facilitate the reconstruction of nonclinical laboratory studies. These provisions are designed to promote replicability for purposes of verifying data (or addressing flaws or assumptions), while also ensuring that laboratories take a structured approach to conducting reliable and ethical research.
- Providing Overall Accountability – Accountability is one of the key themes not only of the GLP regulations, but of the FDA’s efforts to regulate laboratories and research (both clinical and nonclinical) in general. Given the FDA’s limited ability to evaluate studies at the rate they are conducted today, it relies on laboratories to self-regulate (to an extent)—though, as discussed below, it does not hesitate to hold laboratories accountable when necessary.
Focusing on the fundamental purpose of the FDA’s GLP regulations can help with understanding and assessing laboratories’ compliance obligations. Additionally, even if a particular step or measure is not specifically required for purposes of FDA GLP compliance, if the step or measure helps to assure quality and integrity, facilitate study reconstruction, or provide overall accountability, it may nonetheless be prudent within the context of a laboratory’s overall compliance and risk management efforts.
2. The FDA’s GLP Regulations Were Borne Out of Extensive Fraud and “Poor Laboratory Practices”
Another important overarching consideration for lab execs when it comes to FDA GLP compliance is why the FDA chose to implement the GLP regulations in the first place. The GLP regulations were borne out of the FDA’s relatively lax oversight of nonclinical laboratory studies through the early 1970s, when the FDA conducted a broadscale investigation that “[u]ncovered numerous fraudulent activities and poor laboratory practices.”
The FDA’s adoption of the GLP regulations was a direct response to these findings. While it has now been well over 40 years since the FDA adopted the first iteration of the GLP regulations, enforcement in this area remains a top priority for the FDA’s DNDSI, OSIS, and other offices within the agency.
3. The FDA’s GLP Regulations Apply Specifically (and Exclusively) to Nonclinical Laboratory Studies
The GLP regulations apply (and only apply) to nonclinical laboratory studies. As defined by the FDA, these are studies that “support or are intended to support applications for research or marketing permits for products regulated by the Food and Drug Administration,” including “human drugs, biological products, cosmetics, medical devices for human use, electronic products, food and color additives, veterinary drugs, feed additives, and tobacco products.”
Thus, although the scope of the GLP regulations is limited, it is still extremely broad. All labs that conduct nonclinical laboratory studies are subject to GLPs. Studies conducted for purposes of securing FDA approval of drugs, medical devices, tobacco products, electronic devices, and other regulated products must fully comply with the GLP regulations. This includes adequate size for animal care, storage, handling test and control articles, as well as special routines and procedures. As listed by the FDA, the only types of studies that fall outside of the GLP regulations are studies utilizing human subjects, what the FDA terms “basic research,” discovery toxicology studies, nonclinical PK evaluations (that are not party of an otherwise GLP-regulated study), determining whether a test article has any potential utility or to determine physical or chemical characteristics of a test article, and bio-analysis of samples for clinical trials.
4. FDA GLP Compliance Requires a Comprehensive and Detail-Oriented Approach
The GLP regulations are extensive. Laboratories that conduct nonclinical studies for purposes of seeking, securing, and maintaining FDA approval must take a comprehensive and detail-oriented approach to compliance. As with other aspects of FDA compliance, overlooking even a single regulatory requirement can create exposure during an FDA inspection or investigation—and this exposure can potentially lead to civil monetary penalties (CMP), injunctions, further scrutiny, and additional consequences.
At Oberheiden P.C., we provide full-service FDA GLP compliance representation to laboratories nationwide. Our services include:
- Evaluation of laboratories’ specific compliance obligations under the GLP regulations
- Development of custom-tailored FDA GLP compliance policies and procedures
- Assistance with implementing laboratories’ compliance policies and procedures
- Training programs for executives, researchers, and other relevant personnel
- Pre- and post-study FDA GLP compliance assessments
Our lawyers have extensive experience in all areas of FDA compliance. Along with representing laboratories, we also represent drug companies, medical device manufacturers, food and cosmetic companies, veterinary product manufacturers, tobacco products manufacturers, radiation-emitting electronics manufacturers, and a wide range of other clients. We rely on the experience gained from this representation to assess our clients’ GLP compliance needs and efforts, provide targeted compliance advice, and work with the FDA on behalf of our clients as necessary.
5. GLP Compliance Isn’t the Only Area of Concern for Laboratories that Conduct Nonclinical Studies
Finally, while compliance with the GLP regulations is a critical concern for laboratories that conduct nonclinical studies, this is far from the only aspect of FDA compliance of which lab execs need to be aware. Depending on the scope and nature of a laboratory’s operations and the specific types of FDA-regulated products it studies, it may need to meet a variety of other legal and regulatory requirements as well. As a full-service FDA compliance law firm, we assist our clients with understanding and addressing the full scope of the laws and regulations that govern their clinical and nonclinical operations.
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55th Speaker, U.S. House of Representatives (ret.)
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Former U.S. Secretary of State
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Former Senior DOJ Trial Attorney
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Former Prosecutor
Roger Bach
Former Special Agent (DOJ)
Chris J. Quick
Former Special Agent (FBI & IRS-CI)
Michael S. Koslow
Former Supervisory Special Agent (DOD-OIG)
Ray Yuen
Former Supervisory Special Agent (FBI)
FAQs: Effectively Managing FDA GLP Compliance for Nonclinical Laboratory Studies
When Do the FDA’s GLP Regulations Apply?
The FDA’s GLP regulations apply when laboratories conduct nonclinical studies for purposes of supporting applications for FDA approval. This includes (but is not limited to) studies that support applications for a research or marketing permit for FDA-regulated products. When in doubt, laboratories should engage experienced FDA compliance counsel to determine whether the GLP regulations apply.
What Are the Risks if a Laboratory Is Not GLP-Compliant?
For laboratories, the risks of failing to maintain strict compliance with the FDA’s GLP regulations can include both administrative penalties and civil monetary penalties. Findings of noncompliance can also increase the risk of facing additional FDA oversight during future inspections; and, in the commercial context, failing to maintain FDA GLP compliance can expose laboratories to liability under their contracts with product manufacturers, sponsors, and other companies as well.
What Do Laboratories Need to Do to Establish FDA GLP Compliance?
Establishing FDA GLP compliance requires a multi-faceted approach that is custom-tailored to the specific types of studies a laboratory conducts as well as the laboratory’s specific testing environment. Written policies and procedures, internal training and implementation, and ongoing compliance monitoring are three key overarching elements of an effective FDA GLP compliance program.
Does the FDA Inspect Laboratories for GLP Compliance?
Yes, the FDA inspects laboratories for GLP compliance. With this in mind, laboratories that conduct nonclinical studies that are subject to the GLP regulations must take proactive measures to affirmatively demonstrate compliance so that they can withstand FDA scrutiny when necessary.
How Can I Ensure that My Laboratory is GLP-Compliant?
Ensuring that your laboratory is GLP-compliant starts with engaging experienced FDA compliance counsel. At Oberheiden P.C., our lawyers and consultants have extensive experience with all aspects of FDA laboratory compliance, and we can work closely with you to ensure that your laboratory is doing everything the GLP regulations require.
Speak with an FDA Compliance Lawyer at Oberheiden P.C. in Confidence
If you need to know more about implementing an effective FDA GLP compliance program, or if you are preparing for an FDA inspection under the GLP regulations, we invite you to contact us for more information. To speak with an FDA compliance lawyer at Oberheiden P.C. in confidence, please call 888-680-1745 or request a complimentary consultation online today.
