Quality assurance unit establishment

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 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. 

As previously indicated, these GLP regulations and international guidelines were written to address the issue of the conduct of studies and assuring their quality. In order to address these issues, each of the regulations and the international guidelines calls for the establishment of a Quality Assurance Unit or "quality assurance function" within each laboratory. They also specify that certain tasks be carried out by this unit or function. These requirements have resulted in the creation of a new scientific, managerial professional - the quality assurance unit... 

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. 

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... 

There are several areas in the GLP guidelines which are more difficult to implement in an academic setting than in other settings. These are requirements for a separate Quality Assurance Unit (QAU) and the responsibilities thereof establishing Standard Operating Procedures (SOP s) and conformance to them as written and the significant added costs of doing business under the GLP s. 

Management must designate a Study Director, who establishes a Quality Assurance Unit and is responsible for validating results. 

Assure there is a quality assurance unit (QAU) established ... 

All personnel musthave adequate education, training, and experience. Resumes, job descriptions, and training records must be on file for all personnel sufficient staff must be available to conduct studies. Management must designate a study director, who establishes a quality assurance unit and is responsible for validating results. 

Ozone and ozone precursor concentrations at nonurban locations in the eastern United States were studied extensively. The three parts of the study were field measurements, a quality assurance program, and an airborne monitoring program. The main objective of the study was to establish a data base for nonurban ozone and precursor concentrations. Simultaneous statistical summaries of the concentrations of nitrogen dioxide and nonmethane hydrocarbons were also provided. Another objective was to search for relationships between ozone concentrations and nitrogen dioxide and nonmethane hydrocarbon concentrations. 

Drug product production and control records are not certified by the quality control unit to assure compliance with all established, approved written procedures before a batch is released or distributed. 

FDA regulations require that domestic or foreign manufacturers of regulated products intended for commercial distribution in the United States, establish and follow controls as part of a quality assurance (QA) program. These controls help to ensure that regulated products are safe and effective. The QA controls and associated records required by the FDA are contained in the applicable predicate regulations. 

An independent Quality unit be established (like Quality Control and/or Quality Assurance). 

Quality assurance activities actually begin early in the drug development process—in the analytical phase. United States requirements5 are established as early as non-clinical laboratory studies. At this early phase, the audit program concentrates on in vivo and in vitro experiments, focusing on early drug entities. These drug entities are tested under laboratory conditions to determine their potential safety risk. At this phase, human subjects (e.g., clinical studies) or field trials in animals are not involved. 

Since the early 1980s, there has been a more than fivefold increase in the number of Americans enrolled in HMOs, which has had a dramatic impact on the delivery of healthcare in the United States. As a result of this trend, HMOs realized the need to demonstrate the quality of care they provided to their members compared with fee-for-service health plans however, at the time the industry lacked established standards. Subsequently, various independent review processes evolved, which often did not have consistent assumptions about the parameters that defined quality. It was not until the late 1980s that a group of HMO industry leaders recognized that an organization called the National Committee for Quality Assurance (NCQA) had the potential to act as an independent authority on quality control in managed care. ... 

This document provides guidelines for United Nations procurement agencies, but they may also be used by other procurement agencies to establish quality assurance systems for their own activities. 

Before proceeding further with a Test Facility Inspection, it is advisable for the Inspector(s) to establish contact with the facility s Quality Assurance (QA) Unit. 

Quality assurance activities actually begin early in the drug development process—in the analytical phase. United States requirements are established as early as nonclinical laboratory studies. At this early phase, the audit program concentrates on in vivo and in... 

Every manufacturing establishment should have a quality control system so designed as to assure that drug products are manufactured in accordance with adequate conditions and procedures and will continue to meet the established specifications. For this purpose there should be an appropriate and independent Quality Control unit. 

Every pharmaceutical establishment must device and implement a system of quality assurance which is an organized collection of pre-established measures, up to date and systematically applied and verified, and intended to guarantee that each unit produced will have the required quality. 

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