Quality Assurance Unit, responsibilities

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. 

There must be systems in place to monitor the study while it is in progress and to check that all systems are working in accordance with GLP requirements, to record any problems identified and to ensure that remedial action is taken. The person responsible for these quality assurance procedures must be independent of the study being audited. In large organizations, there may be a separate Quality Assurance unit but this will not be practical in smaller organizations. 

The format of the final report from a study is closely defined and the Study Director is responsible for its production. The test item and name of the study must be clearly identified, along with the start and end date. It has to be accompanied by a statement from the Quality Assurance unit that the study and any critical aspects of the work have been conducted to the requirements of GLP principles. It will contain the names of all those involved with the study and their address this includes the Study Director, the Principal Investigator, and all the scientists... 

The proposed regulations went beyond these basic requirements for a valid study by requiring each study to have a study director who would have ultimate responsibility for implementation of the protocol and conduct of the study [ 3e/31(a)], and each testing facility to have a quality assurance unit to monitor conduct of studies. The concept of a quality assurance unit to monitor study conduct was a new one to most laboratories but a familiar one in manufacturing facilities operating under various GMP regulations. 

Maintenance of an independent quality assurance unit within the laboratory to be responsible for a master schedule, sample receipt, and periodic inspections of the conduct and reporting of each laboratory study. 

Management has both directive and supportive responsibilities for the operations of the quality assurance unit to fully achieve compliance with Good Laboratory Practice regulations (1,2). The tone for the entire testing facility is set by management since it is their ultimate responsibility to establish and endorse procedures and policies which ensure a commitment to quality. 

Quality Assurance, the responsibility of the quality assurance unit, is the nitpicking, but totally necessary, job of determining the quality of conformance to regulations established by managers and their chemists and is done via audits and inspections. To develop a thorough quality program both quality control... 

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. 

The quality assurance unit is responsible for monitoring each study to assure management that... 

Management must designate a Study Director, who establishes a Quality Assurance Unit and is responsible for validating results. 

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. 

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. 

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