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Quality assurance unit definition

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. [Pg.59]

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. [Pg.71]

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. [Pg.29]

If the laboratory investigation does not provide a definitive cause for the OOS result, a formal investigation prescribed by a predefined written procedure should commence. The formal investigation should be conducted under the auspices of the quality assurance unit and encompass all other departments that could be implicated, such as production, process development, engineering, and maintenance. [Pg.385]

Although there are many similar definitions for traceability, the essence of trace-ability is an unbroken pathway to the definition of the accepted units used to express the measurement result and a measurement process in which quality assurance is an integral component. [Pg.250]

Although a united compost quality system of the European Union does not exist, the European Compost Network (ECN), as an initiative of the ORBIT Association developed a Quality Assurance System providing the necessary background information and documentation to build up a European Quality Assurance System (ECN-QAS). Product definitions and characterizations of this system are shown in Table 12.7. [Pg.336]

Goal definition and scoping is the initial step of a LCA. It determines the purpose of the study, the scope, the functional unit and a procedure for quality assurance of the result (Figure 4.3). Sources for the data to be entered into the analysis should be identified, as should the type of impacts to be evaluated in the impact assessment. [Pg.80]

The United States Pharmacopeia/National Formulary contains a section or monograph on each of the following gases air, carbon dioxide, cyclopropane, helium, nitrogen, nitrous oxide, and oxygen. Definite standards and methods of testing are prescribed in each USP/NF monograph to assure a product of appropriate quality and purity. [Pg.73]


See other pages where Quality assurance unit definition is mentioned: [Pg.64]    [Pg.71]    [Pg.206]    [Pg.126]    [Pg.3064]    [Pg.155]    [Pg.1]    [Pg.158]    [Pg.246]    [Pg.1008]    [Pg.922]    [Pg.105]    [Pg.78]   
See also in sourсe #XX -- [ Pg.38 , Pg.51 , Pg.52 , Pg.53 , Pg.54 ]




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