Quality assurance unit inspection

If the test facility claims to be GLP-compliant but is located in a country where there is no authorised body responsible for GLP monitoring, i.e., a national GLP compliance program, the Study Director needs to be assured that the facility (including the archive, if used) does operate in compliance with GLP principles. This can be achieved by conducting a pre-study QA test site inspection or by a review of documentary evidence, e.g., notice of adverse findings and subsequent responses, or Establishment Inspection reports. The Study Director should ideally discuss the above with QA personnel and send copies of any documentary evidence used to the Quality Assurance Unit (QAU) for inclusion in the QA multi-site study file. 

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. 

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. 

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. 

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... 

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

Many commentators wanted the inspection records compiled by the quality assurance unit excluded from the records to be inspected by the agency on the basis that an inspection might violate the constitutional privilege against... 

Already the Consensus Document on Quality Assurance (OECD No. 4, 1999) had recognised that these two possibilities would not sufficiently describe the real-life inspection activities of a Quality Assurance unit, and the revised GLP Principles have acknowledged this extended view of inspection types. Inspections dealing with the conduct of, and the activities within, a study are now further subdivided into two different types, so that there are finally three types of inspections, which are just named in the OECD Principles, are described in the OECD Consensus Document on Short-Term Studies (OECD No. 7,1999), and which have to be further specified by Quality Assurance Programme Standard Operating Procedures. These three types are ... 

Firstly, field studies may involve similar activities at separate locations but at similar times. The exact timing of inspectional activities may furthermore depend upon local weather or other conditions, which would necessitate flexibility in the Quality Assurance procedures. Especially when such a study would involve not only multiple sites, but narrow crop windows and field sites without Quality Assurance units, this would severely impact upon the possibilities of a Quality Assurance unit. 

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

This study has been inspected by the Quality Assurance Unit, and the findings have been reported to Management and the Study Director on the following dates. 

The logical dissection of the various possibilities wiU, by application of the guiding idea of GLP, provide the unambiguous answers. The Lead Quality Assurance unit has to judge and attest to the overall GLP compliance of the study. If this Lead Quality Assurance cannot perform the necessary inspections itself, then it has to rely, for this judgement to be rendered, on the reports and statements of any secondary Quality Assurance, irrespective of whether this secondary Quality Assurance were employed by the same... 

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