Good laboratory practice (GLP) is a set of principles designed to ensure the quality and integrity of data from nonclinical drug safety studies necessary to secure government approval of new drug, biological and non-pharmaceutical products.

GLP labs not only ensure ethical treatment of animals but also generate sound evidence of the validity, integrity, and reliability of the nonclinical safety data that regulatory agencies require to approve use of the product in clinical studies on humans.

The source of GLP requirements in the United States are Food and Drug Administration (FDA) regulations, specifically 21 CFR 21 58, Good Laboratory Practice for Nonclinical Laboratory Studies. The rules come into play during the preapproval phase of FDA regulation when companies must demonstrate product safety and effectiveness on animals before proceeding to clinical trials.

FDA inspectors have authority to inspect labs, records, and specimens “at reasonable times and in a reasonable manner” to ensure compliance with GLP. If a lab refuses to undergo inspection, the FDA will not include the study in support of the company’s application for premarket approval of the product.

Here’s an overview of the 9 key elements of GLP regulations and how to comply with each:

Maximizing safety and minimizing risk begins with ensuring that nonclinical studies are performed by appropriate personnel. GLP regulations thus establish rules for personnel. Labs generally need three roles to perform a nonclinical study: i. analysts to perform the work; ii. management to reviewing it; and iii. quality assurance (QA) review. While the analyst and manager can be the same individual, QA must always be an independent person. To comply:

The regulations require a scientist or other professional with appropriate education, training and/or experience to serve as study director with overall responsibility for its technical performance. Lab management must designate the director before the study begins and replace him/her as necessary thereafter. To comply: the study director must be the single point of control with responsibility for:

Use of QA processes to minimize product risks is the essence of GLP. Accordingly, the regulations require labs to establish a QA unit responsible for monitoring study compliance with GLP. To comply: ensure the QA unit is separate from and independent of personnel directing and conducting the study and that it exercises the following functions:

GLP regulations require that nonclinical studies be carried out in testing facilities of suitable size, design and construction. To comply: ensure your lab facility has a sufficient number and adequately equipped facilities for all studies, including animal care, storage and handling test and control articles, storage of test and control article mixtures and performance of required routine and specialized procedures.  

Qualification of the analytical instruments and software used to generate, measure and analyze study data is the heart of GLP. Qualification goes beyond simple calibration, cleaning, maintenance and inspection; it often requires performance of validation tests to verify that instruments are fit for intended use and can be relied upon to operate and produce accurate results in accordance with the study protocol. Lab instrumentation is a key target of inspection and lack of sufficient qualification procedures and documentation a frequent source of FDA citations and warning letters.

The GLP regulations establish rules for lab facility operation, including the requirement that written SOPs be implemented for performing nonclinical studies. To comply: at a minimum, be sure you have an SOP for:

Every study must have a written protocol reviewed by the study director that includes a description of the study purpose, experimental design, methods of controlling bias, and information about other essential aspects of the study bearing on product safety and effectiveness.

Labs must prepare a signed and dated final report for each study that includes, among other things:

The final step in GLP compliance is to retain all study documentation records, raw data and specimens the regulations require you to maintain for whichever of the following periods is the shortest:

Exception: Studies supporting applications for investigational new drugs (INDs), or investigational device exemptions (IDEs) must be retained for at least five years from the approval date in all cases.

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