Quality assurance units practices

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. 

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. 

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. 

Ms. Koelman is currently global GLP/GCP (Good Clinical Practice) QA director within Solvay Pharmaceuticals. Previously, she was head of the GLP Quality Assurance Unit of Solvay Pharmaceuticals. She has been the leader of the project team that set up the local computer validation policy of Solvay Pharmaceuticals B.V. and also leader of the team responsible for implementing this policy in the company over a period of two years, before it was handed over to a permanent Computer Validation Committee. She has been involved in a number of validation projects of different types of systems, ranging from simple equipment to complex custom-built or highly customized applications. 

Quality Assurance Unit (QAU). The testing facility must have a quality assurance unit (QAU) which is responsible for assuring management that the facilities, equipment, personnel, methods, practices, records and controls are in conformance with the GLPs. The QAU must be entirely separate from and independent of the personnel who are engaged in the conduct or direction of the study (3). 

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. 

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... 

McGovern MM, Benach M, Wallenstein S, Boone J, Lubin IM (2003) Personnel standards and quality assurance practices of biochemical genetic testing laboratories in the United States. Arch Path Lab Med 127 71-76... 

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