Quality assurance unit audit

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. 

Sponsor companies use quality assurance units independent of the clinical research group to audit medical operations. Their role is to ensure that regulatory standards and company policies and procedures for clinical research are being followed in all countries where research is being conducted. 

Laboratories may indicate that they do quality work and adhere to GLP regulations and/or ISO guidelines, but they must also prove that they do so. Thus, the GLP regulations provide for audits by the quality assurance unit as well as by EPA or FDA inspectors, and ISO registration will also involve an audit process. 

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. 

Preparation In preparing for an audit, all data and documentation for the study are assembled for the inspectors to view (Figure 8.3). The study director, or other designated technical contact, should review the files and prepare to answer any questions. The master schedule and all files assembled by the quality assurance unit should be reviewed. An agenda, a work space, and a test facility floor plan should be prepared for the inspectors. The staff should be fully briefed and prepared for the visit. 

Quality assurance unit records are exempt from routine FDA inspection and copying authority on the theory that such records are more likely to be complete and candid if they are exempt from review by the FDA. This exemption extends only to records of QA inspection and audit findings and records of corrective actions recommended and taken. All other QA records are subject to inspection and cop5dng by FDA. 

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... 

The Generic Medical Implementation Plan also specifies that the systems contractor s quality assurance unit must conduct regular audits of the systems contractor s occupational health program and that an annual audit of the program must be conducted by PMCD-designated health care professionals. Reports of all audits are forwarded to the clinic medical director and the medical administrator for prompt action. Nonconformance requires a written plan for corrective action. 

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

Quality Assurance Unit—independence, master schedule, audits, and inspections... 

Program Guidance Manual, 2006), stating Clinical trial quality assurance units (QAUs) are not required by regulation. However, many sponsors have clinical QAUs that perform independent audits/data verifications to determine compliance with clinical trial SOPs and FDA regulations . 

Neither the procedures involved in this study nor the report of this study require to be inspected or audited by a Quality Assurance Unit... 

With the guidance for inspections and study audits provided by the OECD documents, the national monitoring authority assumes the role of a Super-Quality Assurance , in the sense that it wiU inspect the adherence of test facilities to the GLP Principles in an analogous way as the individual Quality Assurance units do it for the single test facility. Indeed the OECD document presented in Appendix IV.II ( Revised Guidance for the Conduct of... 

The quality assurance unit is generally independent from the laboratory and answers to the manager of the organization with which the laboratory is affiliated. The QAU is responsible for implementing quality procedures and assessing them on a continuing basis this will include audits of the laboratory from time to time. 

Monitor study—study director and quality assurance unit must audit work in progress and... 

Prepare report—add data tables and interpretations to preprinted report format review final report for completeness and accuracy and acquire all necessary signatures. Submit the final report to quality assurance unit for audit. 

The study director is the only person with overall control and responsibility for a study. The quality assurance unit provides an audit function to ensure that the study complies with GLP requirements. 

The audit also emphasizes the self-regulated nature of the industry and the ideal relationship between the agency and the industry. In theory and effective practice, a biomedical company utilizes its quality assurance (QA) unit (in this case, supplemented by credible Part 11 auditors) to maintain control of safety, effectiveness, and quality. The FDA can then review the quality system (QS) and spot-check the other systems such as laboratory or production for most efficient regulatory oversight. In effect, the QA regulates the company and the FDA regulates the QA. 

Each study is audited by a Quality Assurance (QA) unit Description of quality system is in SOPs... 

By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of... 

The principles of GLP require an independent quality assurance (QA) program to ensure that the study is being conducted in compliance with GLP. The QA personnel cannot overlap with those of the study because of the potential conflict of interest, but they may be part-time staff if the size of the study does not warrant a full-time QA section. The responsibilities of the QA unit are to maintain copies of plans, standard operating procedures, and in particular the master schedule of the study, and to verily, in writing, that these conform to GLP. The QA unit is responsible for inspections and audits, which must be documented and the results made available to the study director and the principal investigator. The QA unit also signs off on the final report. Any problems discovered or corrective action that is recommended by the unit must be documented and followed up. 

Quality assurance activities actually begin early in the drug development process—in the analytical phase. United States requirements5 are established as early as non-clinical laboratory studies. At this early phase, the audit program concentrates on in vivo and in vitro experiments, focusing on early drug entities. These drug entities are tested under laboratory conditions to determine their potential safety risk. At this phase, human subjects (e.g., clinical studies) or field trials in animals are not involved. 

Quality assurance activities actually begin early in the drug development process—in the analytical phase. United States requirements are established as early as nonclinical laboratory studies. At this early phase, the audit program concentrates on in vivo and in... 

The quality assurance department within a company will frequently conduct audits of investigator sites, either during a clinical study or after it has been completed. Companies that do not have a quality assurance department or unit may contract this service from a consultant or a third party specializing in regulatory audits. The intent and scope of these audits are the same as the FDA, but they afford a company an opportunity to verify compliance and to correct deficiencies that might otherwise delay product approval. These audits... 

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