Quality assurance auditing

The project review or a quality assurance audit will verify that all required records and drawings are accounted for, filed, and stored as prescribed. 

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. 

Contract Lab Audits Quality Assurance Audits also occur at the site of the contract laboratories. Of course, the contract laboratories must be aware... 

Although a thorough validation cannot rule out all potential problems, the process of method development and validation would address the most common ones. Examples of typical problems that can be minimized or avoided include interferences that coelute with the analyte in liquid chromatography (LC), a particular type of column that no longer produces the separation needed because the supplier of the column has changed the manufacturing process, an assay method that is unable to achieve the same detection limit after a few weeks, or a quality assurance audit of a validation report that finds no documentation on how the validation was performed. 

Finally, QA is the effort taken to ensure compliance with government regulations for the systems, facilities, and personnel involved with manufacturing products. Quality assurance audits will be quite varied in scope to achieve this assurance. These responsibilities include batch record reviews, critiques of product design, process validation activity, and, possibly audits of other departments operations. 

Company has not conducted periodic quality assurance audits in accordance with written procedures. These procedures call for semi-annual until compliance is achieved and annual audits thereafter. The last quality assurance audit was conducted in 1996. Similar to the FD-483 observation above, this observation rose to the level of a warning letter citation because of the importance and requirement of an FDA-regulated company to employ a formalized quality assessment program. 

GLP because the sponsor did not ask for a GLP compliant study. Where there is no obvious need for the application of the full requirements of GLP, e.g. no need for a formal Quality Assurance audit of the final report, it would seem to make no sense to apply these special regulations and thus to add to the administrative burden with no rewards whatsoever. However, in such a test facility, it would be of the utmost importance that in all other respects studies would be performed as if they were conducted under GLP Apparatus should be maintained and calibrated according to the respective SOPs, test systems should be properly located and identified, test items should be characterised and labelled, SOPs should be available for all activities performed at this test facility, the studies should be conducted to the applicable SOPs, the respective raw data should be treated in a manner analogous to those in a GLP study, and all these activities should be properly documented and recorded. Only if the personnel of this test facility were not allowed to apply two different standards in doing their work will it be ensured that a real GLP study, if one is to be performed, will truly be in compliance with the GLP Principles. 

The underlying principle of GLP requires that the retention of records, other documentation, samples and specimens should provide, wherever possible, the means for full study reconstruction. Thus, it follows logically that also samples from each batch of test and reference item should be collected and retained. In this way it can be ensured that any questions regarding the quality, purity, stability and identity of the test item, that might turn up during the Quality Assurance audit or the scientific assessment of the study, could be resolved by an independent analysis of the reserve sample, without necessitating the repetition of the study itself in case of major doubts about the test item. The requirement that a sample for analytical purposes from each batch of test item should be retained would therefore not seem to pose major problems of interpretation and implementation. 

If you toured a lab facility, you probably toured a wet lab, a quality control lab, or perhaps a process development lab, or maybe all of the above and wondered what these terms meant. You probably saw a control chart and wondered what it was. You may have sat in on a meeting to prepare for the upcoming quality assurance audit and wondered what an audit actually was or what GLP, MSDS, and SOP meant. You may have heard someone talk about certified reference materials and wondered what that was. You may have encountered a formal means of disposing of chemical waste and said, Wow Or you may have noticed an experiment or an instrument that wasn t working properly and, subsequently, observed chemists and technicians teaming together for troubleshooting. 

Quality assurance audits—As part of due diligence service to clients, agents frequently visit and audit manufacturing sites to train staff and upgrade the plants quality systems to the customer s standard before a client audit. 

Reconciliation of study medication Return of study medication to sponsor Quality Assurance audits ... 

The inspection of the capability of the process in order to gain the required assurance as to the fitness for purpose of the developed software—a measure of its validatabillty—is referred to here as a software quality assurance audit. The software quality assurance audit is occasionally referred to as a Supplier Audit (e.g., in the GAMP Guide). However, a Supplier Audit is also used to audit original equipment manufacturers, hardware suppliers, independent contractors and even an internal department with a pharmaceutical organization. There may be no "software" involved at all. For that reason, the term software quality assurance audit is more preferable than Supplier Audit. 

This chapter does not attempt to explore the software quality assurance audit process or the nature of currently accepted standards of good software... 

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