University of Maryland School of Medicine GLP Office
The School of Medicine GLP Office is independent from the labs served and is involved with auditing, training and advising with respect to GLP studies. The GLP program is composed of a both Quality Assurance and Document Management units. Quality Assurance issues, (including protocol reviews, data audits, critical phase audits, facility audits and vendor audits). This office is also responsible for quality assurance preparation and review of reports. Quality assurance also includes continuous training for the GLP community on campus and for individual laboratory training. The GLP office is also responsible for document control including development of SOPs, their storage and dissemination. The GLP office is also responsible for archiving GLP materials at the completion of a study.
The GLP office is charged with maintaining GLP standards on campus. This include:
- Quality Assurance Unit (QAU): The QAU unit will provide audits and inspections (facilities, equipment, personnel, methods, practices, records and controls) that conform with GLP best practices. This includes audits (critical phase, facility reporting and vendors), reviews (for protocols, data, training records and reports), laboratory walk-throughs and maintaining a master schedule.
- Standard Operating Procedures (SOP): The office will assist with the preparation of SOPs, assure that they are uploaded to our document management system, monthly updates of SOPs are provided.
- GLP Training: The QAU will set up annual GLP training on campus. The office will assist in providing training to laboratories beginning GLP studies. The office is eager to provide one-on-one QA and SOP-related training for new individuals working in GLP laboratories. The office also provides both basic and advanced GLP training.
- Archiving: The responsibility of the GLP Office will be to maintain GLP related materials for ongoing studies. After completion of the study the GLP materials will be returned to the Study Director for their records or to return to the funding agency. This will be handled by Sue Messics in the office.
- Document and Database Management: Currently MasterControl is the content server currently being used to develop, store, collate, communicate and archive critical documents in a secure and confidential manner. This system is a 21CFR Part 11 compliant system. The office is responsible to maintain this system for users. Training for document management skills using MasterControl document management system are provided as needed.
Following Good Laboratory Practices (GLP) means more than practicing good science when conducting research experiments. GLPs are federal regulations that apply when conducting safety studies and, in some cases, efficacy studies on certain products regulated by either the Environmental Protection Agency (EPA) or the Food and Drug Administration (FDA). The University of Maryland School of Medicine has developed a GLP Quality System Office that assists research groups at the University of Maryland School of Medicine follow the mandated regulations for GLP studies through training and quality assurance audits.