The goal of this page is to provide a framework for understanding the “basics” of GLP regulations.
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 that the laboratory is generally well organized.
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 has 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!
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.
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, Microchem Laboratory maintains SOPs on everything from media preparation to equipment maintenance.
Accuracy of instruments is critical to experimental accuracy. Thus, the GLPs stipulate calibration requirements for all data generating equipment. For example, Microchem Laboratory 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 Microchem Laboratory 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 Microchem Laboratory 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
Another 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 Microchem Laboratory, 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.