Quality assurance principle

Garfield, F., Klesta, M. E. and Hirsch, J., Quality Assurance Principles for Analytical Laboratories, 3rd Edition, ISBN 0-935584-70-6, Association of Official Analytical Chemists (AOAC) International, Gaithersburg, MD, USA, 2000. 

United States. GMP is defined by the FDA as a federal regulation setting minimum quality requirements that drug, biologies and device manufacturers must meet. It describes in general terms known and accepted quality assurance principles for producing these products. Its components are scientific understanding, documentation, analysis and measurements and personnel matters. Its intended result is total quality assurance and product control. ... 

Garfield, F M, Klesta, E, and Hirsch, J (2000), Quality assurance principles for analytical laboratories, 3rd ed. (Arlington, VA AOAC International). 

Garfield, F. M. Quality Assurance Principles for Analytical Laboratories. Arlington, VA AOAC, 1984. (An excellent volume containing all phases of QA, including forms, equipment, and audits)... 

Morris, C.R. Quality Assurance Principles for Applied Toxicology. In Safety Evaluation Toxicology. Methods,... 

In the USA, there are also no specific decrees or directives for packaging made from recycled materials. However, the Food and Drug Administration (FDA) has published some basic information about the conditions of use of recycled plastics in food packaging applications (US FDA 1992). This information is based on current legislation in the USA and has the backing of American industry (US NFPA 1995). The safety and quality assurance principles involved here concern three fundamental elements ... 

Some systems such as financial management systems will have no impact on GxP unless they contain special functionality that can affect GxP data. Examples would be the use of a zero price to indicate that a product should not be supplied to a particular market/customer. Another example would be financial material reconciliation affecting batch materials usage data. Even if a computer system is not deemed wholly non-GxP, it does not imply that general quality assurance principles are no longer applicable. Good business sense dictates that a quality management approach should always be applied such as TicklT, IEEE, SWEBOK. 

Non-GxP aspects of the system are important to the project from a business perspective. These elements of the system would normally be tested in a similar manner to GxP aspects to demonstrate the consistent application of Quality Assurance principles across the full functionality of the system and in the execution of the project. 

Garfield, F.M., Quality Assurance Principles for Analytical Laboratories. Association of Official Analytical Chemists, 1984. 

The regulatory requirements for validation of pharmaceutical aseptic processes are clear. Generally accepted quality assurance principles require initial... 

In general, there are certain basic quality assurance principles that can be invoked that will satisfy the spirit, if not the hne detail, of most regulatory requirements ... 

F.M. Garfield, Quality assurance principles for analytical laboratories. Second Edition, AOAC International Ed., Arlington VA, USA (1991). 

Audits on all systems, procedures and operations should be regularly conducted in order to monitor compliance with and the effectiveness of Good Manufacturing Practice and Quality Assurance principles in the various operations and to allow for improvement and corrective measures where required. 

Increasingly, residue laboratories have been adopting quality assurance principles that, whilst not guaranteeing that results are correct, increase the likelihood of the data having a sound scientific basis and being fit for purpose. The implementation of a quality system enables a laboratory to demonstrate to its clients that it has the appropriate facilities, equipment, and technical expertise to perform the analyses, and that the work is carried out... 

Not all SSCs require the same frequency and extent of surveillance. The use of quality assurance principles enables the surveillance requirements to be derived in a graded manner such that the extent of the requirements is consistent with the safety functions performed by the SSCs. Account should be taken of the probability of failure to perform properly (PSA results can be used if applicable) and of the requirement to maintain radiation exposures as low as reasonably achievable. The frequency with which SSCs not normally in use are tested should be optimized, so that they can perform their functions satisfactorily when required and possible wear-out due to overtesting is avoided. In deciding on the extent of the surveillance requirements, systems may be classified in accordance with their importance to safety. 

IV.4. The quality assurance principles described in this appendix may in many cases be implemented by one or more organizations, depending upon the arrangements within individual Member States. Such variations will be due to differing national regulatory... 

Gaskin JE (1988) Quality Assurances Principles and Guidelines for Water Quality Sampling and Quality Assurance Principles and Guidelines for the Handling and Management of Water Quality Data. Hull, QC, Canada Water Quality Branch, Inland Waters Directorate, Conservation and Protection, Environment Canada. 

The procedures should be approved and issued after it has been confirmed that no further modifications are considered necessary (Box 6). The procedures should then be entered into the documentation system, included in the plant manual, and treated in accordance with quality assurance principles (Box 7). 

These are the same basic feedback control elements that we find in the Quality Assurance principles of, for example, the International Standards Organisation... 

Causes derived from quality-assurance principles... 

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