Quality Assurance Units QAU

If the test facility claims to be GLP-compliant but is located in a country where there is no authorised body responsible for GLP monitoring, i.e., a national GLP compliance program, the Study Director needs to be assured that the facility (including the archive, if used) does operate in compliance with GLP principles. This can be achieved by conducting a pre-study QA test site inspection or by a review of documentary evidence, e.g., notice of adverse findings and subsequent responses, or Establishment Inspection reports. The Study Director should ideally discuss the above with QA personnel and send copies of any documentary evidence used to the Quality Assurance Unit (QAU) for inclusion in the QA multi-site study file. 

The quality assurance unit (QAU) performs the quality assurance audit. This task is ongoing throughout the study and is the reason for the existence of the QAU. The QAU is the person (see definition of "person" in Box 7.4) designated to perform the quality assurance duties. Thus, the QAU inspects the study to assure integrity and that problems are brought to the attention of the study director. This unit also determines if unauthorized deviations from protocols and SOPs occurred and reviews the final report for accuracy. 

Issues relating to the quality assurance unit (QAU) will be addressed in greater depth in the later discussion of GLP 58.35. 

The quality assurance unit (QAU), the duties of which are described in Part 58.35, presents a special challenge to the FDA investigators. By evaluating QAU activities, the agency is able to assess the mechanisms by which the facihty management assures itself that the nonclinical laboratory... 

The first step is for someone in management to recognize the need for computer systems validation and to gather the other management expertise necessary to address the issue. This person is usually someone in the Quality Assurance Unit (QAU) or the computer operations, Management Information Systems - MIS, group. While these two departments need to be involved, computer systems users such as laboratory leaders, study directors, and other affected department managers need to be included in the development of a computer systems validation plan. 

There are several areas in the GLP guidelines which are more difficult to implement in an academic setting than in other settings. These are requirements for a separate Quality Assurance Unit (QAU) and the responsibilities thereof establishing Standard Operating Procedures (SOP s) and conformance to them as written and the significant added costs of doing business under the GLP s. 

Quality assurance unit (QAU) and internal audits Laboratory equipment and instrumentation... 

The study director is a formal appointment and a key management function for each study. This position is responsible for the scientific conduct of the study as well as for the interpretation, analysis, documentation, and reporting of the result. This person works very closely with the quality assurance unit (QAU) to assure the study is in compliance with GLP. 

GLP regulates all nonclinical studies and was originally intended for toxicity testing only. The requirements of analytical measurements and methods in support of toxicological studies are included in the GLP. The QA/QC may serve as the quality assurance unit (QAU), which is responsible for monitoring each study to ensure that management facilities, equipment, personnel, methods, practice, controls, SOPs, and final reports conform to the regulation. 

Quality Assurance Unit (QAU). The testing facility must have a quality assurance unit (QAU) which is responsible for assuring management that the facilities, equipment, personnel, methods, practices, records and controls are in conformance with the GLPs. The QAU must be entirely separate from and independent of the personnel who are engaged in the conduct or direction of the study (3). 

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