Laboratory quality assurance unit

Table II. Evaluation of Laboratory Quality Assurance Unit...

Quality assurance unit Any person or organizational element, except the study director, designated by testing facility management to perform the duties relating to quality assurance of the (non-clinical laboratory) studies. 

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 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. 

The FDA established a GLP review task team to identify provisions in the regulations that could be amended or deleted, and this team recommended revisions to 36 GLP provisions. Recommendations were issued as a proposed rule on October 29, 1984 [15]. The proposal made various changes to definitions to reduce the amount of paperwork required for nonclinical laboratory studies and to clarify earlier GLP provisions. Similar clarifications were made to the provisions, delineating the definition and function of the study director and quality assurance unit. 

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... 

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. 

As previously indicated, these GLP regulations and international guidelines were written to address the issue of the conduct of studies and assuring their quality. In order to address these issues, each of the regulations and the international guidelines calls for the establishment of a Quality Assurance Unit or "quality assurance function" within each laboratory. They also specify that certain tasks be carried out by this unit or function. These requirements have resulted in the creation of a new scientific, managerial professional - the quality assurance unit... 

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. 

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. 

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. 

I am not going to go into the more obvious quality assurance program requirements that are applicable to all laboratories. These general requirements include the provision for a Quality Assurance Unit, the availability of a qualified staff, the presence of facilities and equipment adequate to permit the type and number of studies being performed, a master schedule of ongoing and completed studies, storage areas for active and used samples, and archives for the retention of reports and raw data. 

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. 

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

If the laboratory investigation does not provide a definitive cause for the OOS result, a formal investigation prescribed by a predefined written procedure should commence. The formal investigation should be conducted under the auspices of the quality assurance unit and encompass all other departments that could be implicated, such as production, process development, engineering, and maintenance. 

---