Big Chemical Encyclopedia

Chemical substances, components, reactions, process design ...

Articles Figures Tables About

Quality assurance practices, general

TIERED APPROACHES TO EXPOSURE ASSESSMENT 144 Deterministic (Point-Estimate) Exposure Assessments 145 Probabilistic Exposure Assessments 145 REPORT WRITING 145 Protocol/User s Guide 146 General Description of Exposure Model 146 Detailed Description of Model Inputs and Outputs 146 Exposure Model Validation 146 Quality Assurance Practices 147 Archiving 147... [Pg.129]

Students are required to acquire ten core competencies and undertake a number of specified specialist/optional units of competence. Core units of competence are common to all sectors in the food processing industry, e.g. dairy processing, flour and stock feed milling, general foods, pet food, and pharmaceutical manufacturing. Such core competencies include application of basic mathematical concepts, basic quality assurance practices, communication in the workplace, the collection, presentation and application of workplace information, and the implementation of occupational health and safety principles and procedures. [Pg.134]

Medicinal products and bulk pharmaceutical chemicals are produced mainly in batch processes. Controlling these products and chemicals at the end of their manufacturing processes is not in line with the general principle of quality assurance, which is that quality should be built into the product. It is then necessary to ensure that appropriate good manufacturing practices are adhered to throughout the manufacture of both bulk pharmaceutical chemicals (active ingredients as well as excipients) and medicinal products. [Pg.513]

Member States shall take all measures necessary to ensure that the laboratories referred to in Article 7 of Directive 89/397/EEC1 comply with the general criteria for the operation of testing laboratories laid down in European standard EN 450013 supplemented by Standard Operating Procedures and the random audit of their compliance by quality assurance personnel, in accordance with the OECD principles Nos. 2 and 7 of good laboratory practice as set out in Section II of Annex 2 of the Decision of the Council of the OECD of 12 Mar 1981 concerning the mutual acceptance of data in the assessment of chemicals.4... [Pg.80]

The audit was divided into two parts (1) General QA Practices and (2) Data Audit. A questionnaire as used by EPA s Office of Pesticide Programs, Quality Assurance Office, for Internal Audits, was employed. A copy of the completed questionnaire is(not) attached. From discussions, based on the questionnaire and observations made during inspection of the facilities and from a data audit, a subjective summary regarding... [Pg.119]

Part 3 practical implementation of the general guideline on quality assurance of culture media in the laboratory. [Pg.60]

Quality assurance associates will generally be using interviews, reviews and audits as the mechanism to determine if the firm is compliant with regulations, current accepted practices (cGCP, cGLP, and cGMP activities), and internal procedures. [Pg.349]

Good documentation constitutes an essential part of the quality assurance system. As claimed in the European Community (EC) Guide to Good Manufacturing Practice (GMP), Chapter 4 Clearly written documentation prevents errors from spoken communications and permits tracing of batch history. In general, the requirements for documentation related to manufacturing of pharmaceuticals, as set in the GMP... [Pg.88]

Quality assurance is practiced at all steps of ceramic manufacture. All raw materials and process conditions are subject to scrutiny. Certification tests are also performed on the product. Proof testing assures that the ceramic part will give properties above those desired for a particular application. Proof testing is performed only when the ceramic part is used for a critical application. Finally, nondestructive investigations of ceramic materials were discussed in very general terms. [Pg.889]

The concept of quality control should be discussed in general comparison with that of the concept of quality assurance. The basic concept of quality assurance is that quality should be assured comprehensively and wholly from the beginning to the end of a fixed volume of successive procedures. It assures that whole data acquired by using the fixed volume come to have a signification result to meet intended objectives. On the other hand, quality control is related only to definite and practical control of respective procedures, and is limited to only some portions of those procedures. Its main objective being maintenance of quality of results within a specific limit. [Pg.232]

The principles and concepts of TQM have been formalized into a quality management process, as illustrated in Figure 19-3. The traditional framework for managing quality in a healthcare laboratory has emphasized the establishment of quality laboratory processes (QLPs), QC, and quality assessment (QA). A QLP includes analytical processes and the general poHcies, practices, and procedures that define how all aspects of the work get done. QC emphasizes statistical control procedures but also includes nonstatistical check procedures, such as linearity checks, reagent and standard checks, and temperature monitors. QA, as currently applied, is primarily concerned with broader measures and monitors of laboratory performance, such as turnaround time, specimen identification, patient identification, and test utility. Quality assessment is the proper name for diese activities rather than quality assurance. Measuring performance does not by itself improve performance and often does not detect problems in time to prevent harmful effects. Quality... [Pg.487]

Quality Control Data. Data obtained from assays of blood gas and pH control materials may be handled in the same way as data from other clinical chemistry determinations (i.e., mean, SD, and coefficient of variation, and control and confidence limits for construction of Levey-Jennings plots). As stability of commercial aqueous control materials is generally several months, vendors often provide data reduction programs that standardize and simplify documentation. However, the resulting reports are temporally delayed and are most useful for meeting accreditation requirements as opposed to real-time corrective or preventive action. They are however useful to compare long-term performances with other laboratories. Equally important features of quality assurance to an active blood gas service are the sixth sense of practiced operators for detecting subtle manifestations of deterioration of instrument performance and the suspicion of trouble expressed by clinicians. [Pg.1012]

As already mentioned above, at several stages of the analytical work and the control of its quality, reference materials (RMs) and certified reference materials (CRMs) are necessary and helpful tools. The present section will summarise all the steps in the work where and when they have to be used. Within the quality assurance scheme and at the three check levels RMs and CRMs are necessary. They are in fact essential for establishing the reliability of the analytical method, the operator and the laboratory as a whole. The practical use of CRMs for method validation will be discussed in Chapter 5 of this book. The general place of RMs and CRMs in QA/QC is shown in Figure 2.15. [Pg.57]

Part Two, "Good practices in production and quality control", provides guidance on actions to be taken separately by production and by quality control personnel for the implementation of the general principles of quality assurance. [Pg.18]


See other pages where Quality assurance practices, general is mentioned: [Pg.120]    [Pg.350]    [Pg.362]    [Pg.22]    [Pg.209]    [Pg.931]    [Pg.1008]    [Pg.169]    [Pg.99]    [Pg.22]    [Pg.847]    [Pg.290]    [Pg.495]    [Pg.268]    [Pg.445]    [Pg.73]    [Pg.67]    [Pg.160]    [Pg.2284]    [Pg.490]    [Pg.159]    [Pg.139]    [Pg.201]    [Pg.29]    [Pg.86]    [Pg.60]    [Pg.68]    [Pg.3]    [Pg.113]    [Pg.124]    [Pg.126]    [Pg.2267]    [Pg.18]   


SEARCH



General practices

Quality assurance

Quality assurance general

Quality assurance practices, general implementation

Quality assurance practices, general laboratory

© 2024 chempedia.info