Personnel quality assurance unit

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. 

Requirements in the areas of facilities, animal care, and personnel were the most often met, while the fewest requirements were met in the areas of the quality assurance unit, mixing and storage of the test substances, and record retention. 

The second Phase, the Preparation Phase, is the phase in which the members of the Quality Assurance Unit and the laboratory personnel... 

With direction from the Quality Assurance Unit, have laboratory personnel themselves prepare for implementation. Do not impose changes from the top down. 

For each nonclinical laboratory study, testing facility management shall...(c) assure that there is a quality assurance unit. (e) ensure that personnel, resources, equipment, materials, and methodologies are available as scheduled, (f) assure that personnel clearly understand the functions they are to perform, (g) assure that any deviations from these regulations reported by the quality assurance unit are communicated.. . and corrective actions are taken and documented. 

The FDA retained the requirement for a quality assurance unit, or function, to monitor studies for conformance to the regulations. It was emphasized that the function was administrative rather than scientific. The personnel responsible for quality assurance for a given study were required to be separate from, and independent of, the personnel responsible for the direction and conduct of that study. 

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. 

Such a situation might therefore put an additional strain on the different Quality Assurance units concerned. Consequently, it has to be ascertained that, irrespective of where the test sites are located, the written reports of Quality Assurance personnel must reach both test facility management and the Study Director. In other circumstances, where there may be no direct, organisational connection between the different parties concerned, i.e., in... 

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