Quality assurance units

Responsibilities of the Quality Assurance Personnel The responsibilities of QA personnel are many. The QA should  

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All formulas are to be written out by hand with the specific numbers in the right places on a sheet provided for the purpose, and the calculations are to be done by calculator. Caution Write the numbers exactly as printed, do not round any digits, or the quality assurance unit (a sort of corporate vice squad) will not approve the report out of fear that someone could have cheated. A validated program can be used. While an Excel spreadsheet as such needs no validation, a simple cell-formula calls for extensive tests and documentation and proof that the sheet is password protected against fraudulent manipulation. On top of that, the analyst s supervisor is required to confirm the calculation and sign off on... 

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. 

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. 

The format of the final report from a study is closely defined and the Study Director is responsible for its production. The test item and name of the study must be clearly identified, along with the start and end date. It has to be accompanied by a statement from the Quality Assurance unit that the study and any critical aspects of the work have been conducted to the requirements of GLP principles. It will contain the names of all those involved with the study and their address this includes the Study Director, the Principal Investigator, and all the scientists... 

Sponsor companies use quality assurance units independent of the clinical research group to audit medical operations. Their role is to ensure that regulatory standards and company policies and procedures for clinical research are being followed in all countries where research is being conducted. 

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. 

Testing facility management Study director Quality assurance unit General... 

The definitions are for those words and phrases that the reader encounters in the regulations. Examples include quality assurance unit, raw data, reference substance, sponsor, study, study director, test substance, test system, testing facility. See Box 7.4 for these definitions. 

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 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. 

Preparation In preparing for an audit, all data and documentation for the study are assembled for the inspectors to view (Figure 8.3). The study director, or other designated technical contact, should review the files and prepare to answer any questions. The master schedule and all files assembled by the quality assurance unit should be reviewed. An agenda, a work space, and a test facility floor plan should be prepared for the inspectors. The staff should be fully briefed and prepared for the visit. 

Define the following terms from the GLP regulations quality assurance unit, raw data, person, sponsor, study, study director, test system. 

What is the purpose of the quality assurance unit according to GLP regulations ... 

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. 

Not surprisingly, many comments objected to the requirement for a quality assurance unit on the basis of increased costs, administrative burden, and interference with management prerogatives and informed scientific judgment of study directors. An alternative solution for study monitoring was not suggested, however. 

Requirements in the areas of facilities, animal care, and personnel were the most often met, while the fewest requirements were met in the areas of the quality assurance unit, mixing and storage of the test substances, and record retention. 

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. 

Issues relating to the quality assurance unit (QAU) will be addressed in greater depth in the later discussion of GLP 58.35. 

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. 

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