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Introduction to GLP Regulations

By Benjamin D. Tanner, Ph.D. - President and CEO, Antimicrobial Test Laboratories

Definition: "GLP," "GLPS," and "cGLPS" all stand (generally) for "Current Good Laboratory Practice Standards," which are US government standards that must be met by laboratories generating data for EPA or FDA.

GLP regulations are frequently misunderstood. The goal of this page is to provide a framework for understanding the "basics" of GLP regulations.

Appropriate Facility Separation between work areas, test systems, and other such things are stipulated by the GLPs. The purpose of the facility rules is to ensure that interference between test articles and test systems does not occur, and also to ensure tha the laboratory is generally well organized.

Clear Roles For a given GLP study, five main characters must be identified. The Study Director is the person who is responsible for running the study, the Study Sponsor is the person who requests the testing, the Quality Assurance Unit is the person (or group of people) who audit the study and final report, the Archivist is the person who maintains study records, and Management is the person (or group of people) who choose the Study Director and supervise both the Quality Assurance Unit and the Study Director. Everybody involved in a GLP study have various levels of accountability with regard to GLP compliance.

Agreed-Upon Study Protocol Before a GLP study is run, a full and detailed study protocol is signed by both the Sponsor (the person paying for the study) and the Study Director (the person conducting the study). Changes to the study protocol require a clear record of when, how, and why the study was changed. Changes to and deviations from the protocol are OK, but they must be documented!

Record-Keeping Arguably the most important aspect of GLP regulation pertains to record keeping. The GLP regulations are intended to provide the government with a fully auditable study record, allowing them to reconstruct every study done per the GLPs. For that reason, all records and raw data that have to do with GLP studies are maintained for long periods of time. Changes to raw data are made in such a way so as not to obscure the original entry. Additionally, the person who entered the data must be identified. Lastly, a safe archive of data must be maintained. The archive is typically fire and theft resistant.

SOPs One critical element of GLP is the concept of an SOP, or Standard Operating Procedure. SOPs are simply documents that describe how a particular scientific task is performed when it is outside of the scope of the signed GLP study protocol. For example, Antimicrobial Test Laboratories maintains SOPs on everything from media preparation to equipment maintenance.

Calibrated Instrumentation Accuracy of instruments is critical to experimental accuracy. Thus, the GLPs stipulate calibration requirements for all data generating equipment. For example, Antimicrobial Test Laboratories regularly calibrates thermometers, balances, and pipettes.

Quality of Media and Reagents All media and reagents used for GLP studies must undergo documented quality testing. For example, agar used for studies at Antimicrobial Test Laboratories is analyzed for both growth promotion of target microorganisms and sterility.

Training Records for Study Personnel Obviously, it's important for the people conducting a study to be educated, trained, and skilled with respect to the study at hand. As such, GLPs stipulate extensive training records be kept for all staff involved in GLP studies. One very unique aspect of Antimicrobial Test Laboratories is the skill and expertise of the staff - literally all scientific personnel have college degrees in the biological sciences, typically in microbiology proper. In addition, many have years of hands on industry experience.

Independent Quality Assurance Audit and Review Arguably the most important aspect of a GLP study is the auditing process. GLP regulations require an "independent" audit of all studies to ensure study integrity. Typically, study auditors are employed by the laboratory, but are removed from participation in the study. At Antimicrobial Test Laboratories, GLP studies are audited at least once during the "critical phase," which means the conduct of the actual study. In addition, study reports are audited to ensure that raw data matches that which is reported, calculations are correct, and so on.