Beginning A GLP Study


Quality System Program Oversight

The Office of Research Compliance and Biosafety (ORCB) in the Division of Research is responsible for monitoring the GLP Quality System through formal and informal, announced and unannounced inspections and audits. The ORCB provides quality assurance services for organizational units participating in GLP studies at Texas A&M.

The ORC will assist organizational units desiring to develop a GLP compliant QSP by providing training, mentoring, educational materials, and performing program assessments.

The Vice President for Research is responsible for assuring a quality system that meets federal requirements for GLP studies is in operation at Texas A&M.The Vice President for Research is the institutional official responsible for QSP oversight at Texas A&M. Delegation of GLP management responsibilities will be accomplished by the VPR.

Approval to Conduct GLP Studies

Organizational units (departments or laboratories) desiring to conduct or provide services for GLP studies must be approved for each study in advance by the ORC. When requests are received a representative from the ORCB’s Quality Assurance Unit (QAU) will meet with the investigator to determine the nature and scope of the GLP project.

The QAU will conduct a formal GLP pre-study inspection and issue a written inspection report to the investigator and the organizational unit’s management. The QAU will recommend corrective actions (if needed) and schedule a re-inspection if the department or laboratory does not satisfy GLP requirements. When corrective actions are completed and the involved organization’s management have approved in writing participation in the GLP study the ORCB will issue a written statement of approval for the proposed study.

The QAU will perform quality system inspections at least biennially to monitor GLP compliance of all Texas A&M facilities approved to participate in GLP studies.

Assistance with Quality System Implementation

The Division of Research has established standard operating procedures (SOPs) for quality assurance, GLP administration, general GLP operations, protocols, data management, reporting, and record retention. The SOPs must be adhered to by all facilities or laboratories approved to conduct or provide support services for GLP studies.

The ORC will consult with managers and supervisors and advise on implementation of the GLP QSP; however, responsibility for implementation rests with the organizational unit.

Glossary

  1. Amendments (protocol, report): A permanent change to a protocol or report that is documented in writing, and approved by the study director and sponsor.
  2. AUP: Animal use protocol
  3. Critical phase: Study activities deemed by the quality assurance unit to be critical to meeting study objectives. Critical phases of each study will be determined based on the nature of the study. For example, the critical phases of a typical medical device or combination product study usually include: protocol development, animal receipt, animal identification, animal quarantine, test and control article receipt, test and control article preparation and administration, surgical procedures, data collection procedures, daily animal observations, necropsy, histology processing, performing histomorphometry, statistical analysis, final reporting, and archiving.
  4. Control articles: Any food additive, color additive, drug, biological product, electronic product, medical device for human use, or any other article subject to regulation under the Food, Drug, and Cosmetic Act or under sections 351 and 354-360F of the Public Health Service Act.
  5. Deviation: A departure from an approved protocol, standard operating procedure, or the GLP regulations.
  6. Electronic records: Any combination of text, graphics, data, audio, pictorial or information in digital form created, modified, maintained, archived, retrieved or distributed by a computer system.
  7. Nonclinical laboratory studies (GLP study): In vivo or in vitro experiments in which test articles are studied prospectively under laboratory conditions to determine their safety. The term does not include studies utilizing human subjects, or clinical studies, or field trials in animals, and does not include studies to determine whether a test article has potential utility or to determine physical or chemical characteristics of a test article.
  8. IACUC: Institutional Animal Care and Use Committee with the responsibility of evaluating animal use protocols.
  9. ORCB: Office of Research Compliance and Biosafety.
  10. Organizational Unit: Any department, laboratory, or facility at Texas A&M that provides or supports research activities.
  11. QAU - Quality Assurance Unit: Any person or organizational element, except the study director, designated by testing facility management to perform the duties relating to quality assurance of nonclinical laboratory studies. The quality assurance unit will monitor each study to assure testing facility management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the GLP regulations. For any given study the quality assurance unit must be separate and apart from the individuals involved in direction or conduct of that study.
  12. QSP - Quality System Program: Processes, procedures, and controls established to ensure a high level of excellence and reliability of the data generated by the system and to ensure conformance with the regulations.
  13. Raw data: Any laboratory worksheets, records, memoranda, notes, or exact copies thereof, that are the result of original observations and activities of a nonclinical laboratory study and are necessary for the reconstruction and evaluation of the report of that study.
  14. Sponsor: (a) A person who initiates and supports by provision of financial or other resources, a nonclinical laboratory study; (b) A person who submits a nonclinical study to the Food and Drug Administration or Environmental Protection Agency in support of an application for a research or marketing permit; or (c) A testing facility, if it initiates, supports, and actually conducts the study.
  15. Study director: The individual responsible for the overall technical conduct of the study, as well as for the interpretation, analysis, documentation, and reporting of results, and represents the single point of study control.
  16. Texas A&M: Texas A&M University, College Station.
  17. Test articles: Any food additive, color additive drug, biological product, electronic product, medical device for human use, or any other article subject to regulation under the Food, Drug, and Cosmetic Act, or under sections 351 and 354-360F of the Public Health Service Act.
  18. Testing facility: An individual, partnership, corporation, association, scientific or academic establishment, government agency, or organizational unit thereof, and any other legal entity who actually conducts a nonclinical laboratory study, i.e., actually uses the test article in a test system. Testing facility encompasses only those operational units that are being or have been used to conduct nonclinical laboratory studies.
  19. Testing facility management: The institutional official responsible for GLP compliance and all levels of management in organizational units participating in GLP studies.
  20. Test systems: Any animal, plant, microorganism or subpart, thereof to which the test or control articles are administered or added for study. Test system also includes appropriate groups of components of the system not treated with the test or control articles. 
  21. VPR – The Vice President for Research, Texas A&M University, College Station.

Personnel

Personnel conducting or supporting GLP studies must document that they are qualified to perform assigned study duties through education, experience, training, or a combination thereof. Study personnel conducting or supporting GLP studies:

  1. Must have GLP training at least biennially.
  2. Must maintain current records of training, education, and job description.
  3. Must follow health and sanitation procedures to avoid contamination of test systems and test and control articles. Departments or units conducting GLP studies must have management approved standard operating procedures defining health and sanitation measures to be followed.
  4. Must wear clothing suitable for the tasks to be performed and to avoid contamination of test systems and test and control articles.
  5. Must report to their supervisor any illness or medical condition that may adversely affect the test article, control article, test system, or performance of study activities and must be excluded from participating in the study until the condition is resolved.

Organizational Structure

The Vice President for Research delegates certain management responsibilities to each organizational unit that is approved to conduct or provide services for GLP studies (refer to Texas A&M SOP for Testing Facility Management). The Division of Research will maintain a current GLP operation and reporting structure charts for all organizational units involved in the conduct or support of GLP studies at Texas A&M.

Testing Facility Management

Testing facility management is comprised of the Vice President of Research, Associate Vice President for Research Compliance, Director of Research Compliance, deans, department heads, directors, managers, and supervisors. Each level of management is responsible for ensuring and maintaining GLP compliance for their respective organizational unit. Texas A&M testing facility management will:

  1. Assure there is a quality assurance unit to provide quality assurance services for GLP studies.
  2. Designate a study director prior to the start of a study when Texas A&M is the primary testing facility (i.e., when the test or control articles are administered to the test system at Texas A&M).
  3. Replace the study director should it become necessary.
  4. Assure that personnel clearly understand the functions they are to perform.
  5. Assure facilities, resources, personnel, equipment, materials, and methodologies are available to meet GLP study requirements.
  6. Assure that test and control articles or mixtures are properly tested to determine their identity, strength, purity, stability, and uniformity (as applicable to the article or mixture).
  7. Assure that any deviations from the regulations, SOP, and study protocols are reported to the study director and that corrective actions are taken and documented.