The University of Arizona

Approval Holder

The Approval Holder is usually a Principal Investigator (PI) or Study Director who obtains a Good Laboratory Practice (GLP) Approval through Research Laboratory & Safety Services (RLSS). The Approval Holder maintains the laboratory to GLP standards set forth by the Food & Drug Administration, and any other university regulations regarding the work with hazardous materials.

Responsibilities

The Approval Holder is responsible for full compliance with the policies, practices and procedures set forth by Research Laboratory & Safety Services. This responsibility extends to all aspects of GLP involving all individuals who enter or work in the Approval Holder’s laboratory. The Approval Holder is responsible for assuring the appropriate safety training of employees, correcting errors and unsafe working conditions, and for documentation of these elements.

General Responsibilities

  • Ensure the work being conducted follows the Food & Drug Administration’s standards listed in 21 CFR, Part 58
  • Develop and implement laboratory-specific safety procedures that are consistent with the nature of current and planned research activities
  • Ensure that all laboratory personnel, maintenance personnel, and visitors who may be exposed to any hazardous material are informed in advance of their potential risk and of the behavior required to minimize that risk. It is essential that everyone who may have any potential exposure to hazardous materials enter and/or work in the laboratory under the Principle of Informed Consent
  • Ensure all workers comply with training requirements set forth by the University of Arizona and Research Laboratory & Safety Services.
  • Ensure that all maintenance work in, on or around contaminated equipment is conducted only after that equipment is thoroughly decontaminated by the laboratory staff or Approval Holder
  • Ensure that research materials are properly decontaminated before disposal and that all employees are familiar with the different methods of waste disposal
  • Comply with shipping requirements for recombinant and biohazardous material
  • Report accidents, exposures or violations to Research Laboratory & Safety Services

Research-Related Responsibilities

  • Supervise the safety performance of the laboratory staff to ensure that the required safety practices are employed
  • Investigate and report to RLSS any significant problems pertaining to the operation and implementation of containment practices and procedures
  • Immediately notify RLSS of any laboratory spills, accidents, containment failure or violations of practice that result in the release of hazardous material and/or the exposure of laboratory personnel (or the public)
  • Correct work errors and conditions that may result in the release of hazardous materials
  • Ensure the integrity of all containment systems used in the project
  • Restrict access as required by the laboratory-specific practices and procedures