Quality Assurance Inspection Reports

Quality Assurance personnel is required by the GLP Principles to promptly report any inspection results in writing to management and to the Study Director,. .. . Since it is also required that records of such inspections should be retained , the work of the Quality Assurance personnel exhibits in many aspects the resemblance of a study There is a plan (exacted by the master schedule), there are raw data (the inspection results, e.g. the filled-in check- lists, see as an example figure 14), and there will be a final report on the findings which has to be submitted to the relevant authorities, in this case the Study Director and the responsible management. However, since the Quality Assurance reports serve an important function, the attention of the addressees of these reports should not be blunted through continuous inundation by reports full of irrelevant details. Therefore, in the case of the Quality Assurance inspection report, this document should describe only the deficien- 

In the most simple case, where the Quality Assurance is located at the same place as the Study Director and the test facility management, there should be no problem with reporting and the subsequent responses from the two addressees. There are, however, more complex situations where the Quality Assurance has no direct connections with the Study Director and his or her management. One might consider for instance the situation in a field study, where parts of the study are performed at test sites remote from the Study Director s test facility. Even if these test sites were to belong to the same 

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Figure 14 Example of some excerpts from a Quality Assurance inspection report, with additional remarks by the Quality Assurance inspector.

National GLP monitoring authorities may request information relating to the nature and dates of Quality Assurance inspections. However, Quality Assurance inspection reports should not normally be examined for their contents by national monitoring authorities as this may inhibit Quality Assurance when preparing inspection reports. Nevertheless, national monitoring... 

Have quality assurance inspection reports, covering fabrication, assembly and installation, been completed in accordance with the project s quality assurance plan and reports filed with the equipment and design basis documentation ... 

Other documentation targeted for storage in archives include the master schedule sheet, copies of protocols, and records of quality assurance inspections, summaries of training and experience, job descriptions, records and reports of the maintenance and calibration and inspection of equipment. In any case, ensure that the protocol or SOPs address the proper archiving of appropriate materials. 

Personnel (i) quality assurance (QA) reports on inspections demonstrate QA oversight and (w)... 

One might possibly be tempted to interpret the economy issue in Quality Assurance resource utilisation also in an additional way, namely that Quality Assurance could perform report audits for short-term studies in just a random fashion, analogous to the inspectional practice. This possibility, however, is precluded by the GLP Principles. They require that Quality Assurance inspect the final reports to confirm that the methods, procedures, and observations are accurately and completely described, and that the reported results accurately... 

Finally, the QAU must review the final study report to assure that it accurately reflects the raw data and SOPs used in the study. The QAU then signs a Quality Assurance Final Report Statement which specifies the dates of inspection, the phases inspected, and the dates findings were reported to the study director and study director s management. With large field studies there may be a number of separate field reports and one or more analytical reports. Generally, the QAU at each of these contractors treats their report as a final report and audits it accordingly. 

Although written reports are the inspecting authority s end product they by no means comprise the whole of the professional service that is supplied or is available on request. The authority s quality assurance objective is likely to be on the lines of client satisfaction allied to compliance with contractual obligations . Although reports are almost certainly monitored, they are a poor indicator of the quality of the examination, and the authority s quality control will rely less on report... 

The program must require the vendors to measure a number of reference samples and/or duplicates submitted in a planned sequence. It should require prompt measurement and reporting of these data and should maintain the results in a control chart format. Prompt feedback and follow-up of any apparent data discrepancies and reconciliation of the results with control charts maintained by the vendors are required to minimize the length of uncertain performance. The quality assurance plan should include random sampling of the vendors data for their validity and conformance with quality assurance requirements. If quality assurance is properly practiced at all levels, an inspection of 5 percent of the total data output should be adequate. 

A quality assurance program statement listing the types of inspections made and their dates, including the phases inspected, and the dates when any inspection results were reported to management, to the Study Director, and to any Principal Investigators, if applicable. This statement would also serve to confirm that the final report reflects the raw data. 

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. 

It is essential that all data generated and any other records or samples (if possible) are retained so that they are available for inspection at a later date. This means that there must be a secure and properly controlled archive, with an archivist to maintain it. The archive will contain a copy of the Study Plan, quality assurance reports, records of staff including their curriculum vitae (CV) and training records. Access to the archive has to be strictly controlled, and any additions to or withdrawals from the archive must be logged (see also electronic records in Section 9.2.1.8). Such removal or additions can only be undertaken by stated personnel. 

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. 

After vendor approval, quality control or quality assurance will reduce the number of tests and inspections of incoming goods as agreed in the certification report, e.g., one out of ten batches. 

Validation Team A well-defined validation team with a well-written description of responsibilities is required and assures the adequate realization of the validation tasks. A validation team should be composed by different responsibilities responsible-of-validation team, team leader, archive manager, test coordinator, quality assurance member, tester, and witness. The responsible-for-validation team elaborates and approves the VMP, protocols, and reports. The team leader should be responsible for the computer system validation and utilization. An archive manager is responsible for the management of all computer system validation documents. The test coordinator is responsible for the computer system test and coordinates the elaboration and operation of tests for evaluating the performance of the computer system. A quality assurance member is required to periodically inspect and train the personnel and review all the validation documents. The tester is responsible for the execution of the tests required to perform the validation protocol. The witness is responsible for observing and reviewing the operations of the tester. 

The principles of GLP require an independent quality assurance (QA) program to ensure that the study is being conducted in compliance with GLP. The QA personnel cannot overlap with those of the study because of the potential conflict of interest, but they may be part-time staff if the size of the study does not warrant a full-time QA section. The responsibilities of the QA unit are to maintain copies of plans, standard operating procedures, and in particular the master schedule of the study, and to verily, in writing, that these conform to GLP. The QA unit is responsible for inspections and audits, which must be documented and the results made available to the study director and the principal investigator. The QA unit also signs off on the final report. Any problems discovered or corrective action that is recommended by the unit must be documented and followed up. 

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—organizational independence, staff qualifications, self-inspection program, AQL, change control procedures, documentation and reports, complaint files, awareness of current regulations, statistical concept employed, batch record turnaround time, etc. 

Quality Assurance is the system of monitoring, inspecting, and auditing which assures that the work is documented and conducted according to protocol and the laboratories standard operating procedures from the conception of a study to the review of the final report. 

After a field inspection is completed, any deficiencies found or recommendations for improvement are discussed with the investigator. This is followed by a written report. The investigator then may append any comments he may wish to make to the report. He signs and dates the report then sends it to his supervisor who signs and dates the report and returns it to the Quality Assurance auditor. 

A quality assurance statement listing the details (types of inspections, dates, phase(s), results, reporting date to management and study director)... 

Howard Garston-Smith, formerly of Pfizer, has published a book on software quality assurance. It provides a postal audit checklist reproduced in Appendix 7C. If the supplier has already prepared an internal ISO 9000 mapping or an internal audit report on how it aligns to industry standards such as the GAMP Guide, this can be offered as an alternative to the auditor s postal checklist. A reduced postal checklist may be agreed upon, at the very least. Wherever possible, photocopies of actual example documents and test records should be inspected for documentary evidence of validation. Remember that the pharmaceutical and healthcare companies are themselves being inspected for documentary evidence of validation. 

A written report of an inspection or audit performed at the manufacturer s site by quality assurance personnel. 

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