QAU manager

QAU Report Following the audits described above, the QAU discusses the findings with the study director and writes an audit report. The study director responds to the QAU report in writing the report is given to the management, signed, and included in the final report. 

Any portion of the study that is a "field study" may also be audited. A field study auditor would inspect many of the same items already mentioned, but at the field site location. These include the training and experience of the field personnel, the calibration and maintenance of equipment, the field management and operations, the test substance application, and the sampling. Special problems are sometimes encountered in the field because the site is physically displaced from the main site of the study. Despite the physical displacement, the equipment must still be calibrated and maintained, the protocols and SOPs must be followed, there must be proper record-keeping, and there must be regular inspections by the QAU. 

The requirement to assure that deviations reported by the QAU are communicated to the study director and that corrective actions are taken and documented does not mean that management itself must communicate the findings and take appropriate corrective action. An efficient QAU will document deviations and the fact that corrective action has already occurred in reports that are distributed to both management and the study director. The need for additional management follow-up will then be necessary only in those few instances in which corrective action was not adequately negotiated between the QAU and the scientific staff before the issuance of the QAU report. When corrective action is un-... 

This section suggests the need for frequent interaction between the study director and QA personnel. Deviations from GLP requirements noted by the QAU must be reported periodically to management and the study director. If those reports indicate that corrective action is stiU needed for any deviation from regulatory requirements, it is the study director s responsibility to assure that corrective action occurs. 

The information to be recorded in QAU inspection records is straightforward, as is the requirement for the QAU to immediately report significant problems to management and the study director. 

The frequency of the QAU s periodic reports to management is left to the discretion of the laboratory. Reports at intervals of approximately amonth are fairly standard within the regulated community. The description of problems noted during QAU inspections need not be extremely detailed unless the problems remain uncorrected. The primary purpose of the report is to assure management that study quality is being maintained and that management intervention is not required. 

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... 

Management must position the QAU within the hierarchy of the organization to vest it with sufficient authority to perform its management defined functions. Further, in order for the QAU to... 

Another supportive role that management must accept is the provision for additional resources when QAU responsibilities are increased either by management, by revised or new regulations, or by increased study workloads. Such resources include personnel, office space, equipment, clerical support, etc. Management must continually review and balance the allocation of resources to the quality assurance and scientific study areas to efficiently operate with the desired level of quality. 

Integration of Quality Assurance concepts into the laboratory is the key to GLP compliance and is usually accomplished in three phrases under the guidance of the QAU. In the Management Phase the basic plan is formulated based on policies decided upon by management. In the second phase the QAU prepares the laboratory for the final implementation phase. General rules for integration are given as are levels of acceptance that may be expected from laboratory personnel. 

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. 

The GLPs require the laboratory to establish an independent QAU to monitor study conduct and audit the final report. This requirement is needed to assure management and the government that the study is being conducted according to the GLP regulations and that the... 

When conducting an assessment of an outside laboratory, the adequacy of the laboratory s QAU and its relationship to management should be determined in addition to assessing the laboratory operations. Questions directed toward evaluating the QAU might include those in Table II. It is often helpful for the QAU to make up a checklist however, the list should be flexible and open-ended so that it can incorporate unanticipated events. 

The QAU must then write an Inspection Report and send it to the Project Manager. The written Inspection Report should be complete and objective. Suggested content is given in Table IV. 

At the end of the audit, a Final Report Narrative is written by the QAU to the Project Manager. The format of the Narrative is similar to that of the Inspection Report. Once again the Project Manager responds in writing, thus establishing a loop the completed Narrative is then forwarded to upper management. 

Method validation must be performed in a regulatory-compliant environment. In particular, the organization must have a QA unit (QAU), adequate laboratory equipment and facilities, written procedures, and qualified personnel. Since a successful validation requires the cooperative efforts of each of these organizational elements, successful fulfillment of the regulatory and technical objectives of validation requires senior management support. Additionally, it is essential that the organization have a well-defined validation master plan (YMP) for analytical methods, which defines the steps necessary to effectively validate methods. 

Internal QA audits must be conducted and documented at a defined frequency to ensure overall compliance, control, and effectiveness of the quality elements. Such audits should be conducted by members of the QAU or third-party compliance specialists and the results reported directly to the senior management of the corporation. The senior management should prepare an action plan to address any deficiencies and follow up to confirm adequate implementation. 

Good laboratory practices require that management establish a QAU to monitor each study to assure conformance with the regulations. The GLPs also state that the QAU must be entirely separate from and independent of personnel engaged in the direction and conduct of the study. 

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