UTMB Research Services - Good Laboratory Practices (GLP)

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Good Laboratory Practices (GLP)

Welcome to the GLP Home Page!

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What is GLP?
GLP is an acronym that stands for Good Laboratory Practices. Both the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) have GLP mandates. The primary focus for this webpage is the FDA GLP regulations as published in the Federal Register, 21 CFR Part 58. This webpage serves as an introduction into the world of GLP compliance. You will find helpful summaries, reference information, education announcements, contact information, networking opportunities, and forms that may be helpful for data documentation.

If you are interested in additional information, please contact Melissa Eitzen, the Institutional GLP Coordinator at mmeitzen@utmb.edu.

Get the Regulations: Good Laboratory Practice (GLP), Amendment, Final Rule, 9/4/1987
Read an Overview of the Regulations

GLP at UTMB

The GLP program at UTMB operates under the direction of Research Services. Formed in 2004, our support staff assists investigators and their staff with GLP compliance. Currently our staff is limited and fully committed to existing grants. If you are considering applying for a grant which requires GLP compliance, please contact Wayne Patterson at wpatters@utmb.edu for further information.

The Quality Assurance Unit

The GLP regulations require that a Quality Assurance Unit (QAU) exist in order to assure that the facilities, equipment, personnel, methods, practices, records, and controls for a GLP study are in conformance with the regulations. At UTMB the QAU is independent from the conduct of the study and plays an integral part in the total quality assurance process. QA staff members audit and inspect study procedures and records in order to assure compliance with the regulations.

GLP Working Group

In order to support currently funded and future GLP studies at UTMB, a working group was formed. The GLP Working Group consists of faculty and staff that are leading their groups towards GLP compliance. The group meets bi-weekly on Wednesday mornings. Topics include equipment qualification, standard operating procedure (SOP) writing, proper documentation of study data, maintaining daily records, establishing personal training files, sponsor inspection summaries. In addition, members share experiences and information gained from site visits to other GLP compliant facilities, articles for continuing education, SOPs, etc. If you are interested in joining the group, please contact: Melissa Eitzen at mmeitzen@utmb.edu.

GLP Training

Research Services often sponsors or jointly sponsors education seminars, lectures, teleconferences, web casts, GLP administrative and QAU Standard Operating Procedure training, etc. Most have limited space available and will be announced on this webpage. Customized arrangements for training for faculty and staff with currently funded GLP studies can be made upon request.

Reference Information

In addition to reviewing the regulations, the following information may be helpful in understanding the scope of the regulations. Please click on the following links for additional information surrounding the GLP regulations:

FDA Guidance for Industry: GLP Regulations Management Briefings Post Conference Report ( http://www.fda.gov/ora/compliance_ref/bimo/q_as.htm)
FDA Guidance for Industry: GLP Questions and Answers ( http://www.fda.gov/ora/compliance_ref/bimo/GLP/81GLP-qanda.htm)
Bioresearch Monitoring GLP Compliance Program 7348.808 (Nonclinical Laboratories) ( http://www.fda.gov/ora/compliance_ref/bimo/7348_808/default.htm)
Recent FDA Warning Letters ( http://www.accessdata.fda.gov/scripts/wlcfm/recentfiles.cfm)
FDA Warning Letter Examples
FDA Notice of 'Opportunity of Hearing' for Testing Facility Disqualification
- Coulston Foundation
Guidance for Industry Bioanalytical Method Validation
FDA Process Validation Guidance
FDA Software Validation Guidance
Workshop/Conference Report--Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays

Suggested Forms

If you are currently working on a study that will require GLP compliance, here are some suggested forms that may help you organize your documentation.

GLP SOPs

Basic SOP Template

Equipment Maintenance

Daily Temperature Log Template (Excel)

SOP Training Documentation:

Documentation of Continuing Education:

Template for Reading a Relevant Article

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