The difference between GMP and GLP is their scope. Good Manufacturing Practice applies to the entire drug manufacturing process while Good Laboratory Practice applies only to the safety testing phase. Both GMP and GLP are enforced by the Food and Drug Administration (FDA) in the United States. Do You Need to Comply with GLP? GLP is also not required during early development stages such as discovery, screening, basic research, and concept assessment. According to the World Health Organization, GLP compliance is typically limited to Stage 2 of the drug development process. Before the study begins, the testing facility manager must appoint a study director who will be responsible for the overall conduct of the study and its GLP compliance. The testing facility must also have a Quality Assurance Unit (QAU) which is separate from or independent of the testing facility organization or management. The testing facility should provide separation of activities to prevent interference and other disturbances which may compromise the study.

All equipment used in the study should be periodically calibrated and maintained. The study plan or protocol is the master guidance document for MedicGLP Online the conduct of the study. It outlines how the study should be performed and contains the general time schedule for the study and its various stages. It also includes the method and materials used in the study. The protocol must go through approval, review, and discussion before the study begins. This process starts with the study director preparing the protocol and discussing its contents with personnel and other study staff. After discussion, the study director must then approve the protocol by affixing their dated signature. Once the protocol has been approved by the study director, it must be reviewed by the QAU, MedicGLP Official Website who will assess its compliance with Good Laboratory Practice. At this point in the process, personnel should be instructed on the duties assigned to them in the protocol as well as receive their own copies of the protocol.

Each of the separate areas in the testing facility should have Standard Operating Procedures (SOPs), especially for routine procedures. SOPs must be approved by the testing facility manager and any deviations from SOPs need to be authorized by the study director. The final report is ultimately the responsibility of the study director, who prepares and approves the report. Throughout the course of the study, the study director will be responsible for ensuring that all data pertaining to the study is captured and included in records that are safely stored. These records and documents such as the protocol, the final report, and standard operating procedures will then be archived at the end of the study. Only personnel authorized by the testing facility manager can access archived records. Additionally, every instance of records being accessed, removed from, or returned to the archives must be logged. It is also recommended that records in the archives be indexed for organized retrieval. The required retention period for archived records varies depending on national GLP regulations.

Were the results of the study submitted to the FDA? If YES: Is the study supporting an Investigational New Drug (IND) application or an application for Investigational Device Exemption (IDE)? If Yes: Archived records must be retained at least 5 years after the date on which the results of the study were submitted to the FDA. If No: Archived records must be retained at least 2 years after the date on which the application for a research or marketing permit was approved by the FDA. If NO: MedicGLP Online Archived records must be retained at least 2 years after the date on which the study was completed, terminated, or discontinued. Wear Personal Protective Equipment (PPE) at all times. Communicate with other members of the research lab. Participate in refresher training and safety exercises. Be aware of what you’re doing at all times. Pay attention to unfamiliar smells and substances. Use the right lab equipment for the task or activity.