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Accreditation and Quality Assurance: Journal for Quality, Comparability and Reliability in Chemical Measurement (v.2, #7)
Selecting parameters and limits for equipment operational qualification by L. Huber; Lou Welebob (pp. 316-322).
While operational qualification (OQ) is a well-established term within equipment qualification, users of equipment often become unsure when it comes to implementation. The biggest problem is how to select procedures and acceptance criteria. Should these be the vendor's specifications or should the users define their own limits, and, if so, how? Should all instruments of the same type have the same values or should these be optimized for each individual instrument? This article will provide an overall strategy and specific examples for HPLC on how to select procedures and acceptance limits that are based on efficient use of resources, on practicality and on the intended use of the equipment.
Keywords: Key words Equipment qualification Operational qualification; Implementation; Acceptance limits; Procedure selection; Abbreviations AU Absorption Units; DQ Design qualification; IQ Installation qualification; OQ Operational qualification; PQ Performance qualification; RSD Relative standard deviation; RT Retention time
Setting a precedent in international accreditation by C. L. Burns (pp. 327-331).
The accreditation procedure that the Department of Laboratory Sciences, CHPPM-Europe underwent is described. The laboratory obtained ISO/IEC 25 accreditation through the American Association for Laboratory Accreditation (A2LA) and the Deutsches Akkreditierungssystem Prüfwesen (DAP) as well as EN 45001 from DAP following the A2LA and DAP joint inspection. The accreditation process and the importance of obtaining national and international accreditation are discussed.
Keywords: Key words Accreditation; Quality system; Environmental analysis; Laboratory; Quality assurance manual
Quality assurance system for a decomposition method as demonstrated for the Wickbold combustion technique by D. Erber; Jürgen Roth; Karl Cammann (pp. 332-337).
A five-step model for a quality assurance system is developed for an internal quality control check. It includes the quality control of the decomposition method and the detection method as steps belonging together. The Wickbold combustion technique as decomposition method in combination with atomic absorption spectrometry was chosen. The vaporization of the elements mercury, arsenic, lead, antimony and selenium is based on combustion in an oxyhydrogen flame. To check the efficiency of the analytical system, the uncertainty of results was calculated on the basis of the "Guide to the Expression of Uncertainty in Measurement".
Keywords: Key words Quality assurance; Decomposition method; Wickbold combustion technique; Uncertainty of results
A validation concept for purity determination and assay in the pharmaceutical industry using measurement uncertainty and statistical process control by Stephan Küppers (pp. 338-341).
The analytical chemists in process development in the pharmaceutical industry have to solve the difficult problem of producing high quality methods for purity determination and assay within a short time without a clear definition of the substance to be analyzed. Therefore the quality management is very difficult. The ideal situation would be that every method is validated before use. This is not possible because this would delay the development process. A process-type quality development approach with an estimation type fast validation (measurement uncertainty) is therefore suggested. The quality management process consists of the estimation of measurement uncertainty for early project status. Statistical process control (SPC) is started directly after measurement uncertainty estimation and a classical validation for the end of the project. By this approach a process is defined that allows a fast and cost-efficient way of supporting the development process with the appropriate quality at the end of the process and provides the transparency needed in the development process. The procedure presented tries to solve the problem of the parallelism between the two development processes (chemical and analytical development) by speeding up the analytical development process initially.
Keywords: Key words Analytical quality; Measurement uncertainty; Statistical process control; Quality process
Developments in the chemical analysis of environmental samples at the edge of the 21st century International Symposium held at Warsaw, Poland on 21–22 November, 1996
by Z. Dobkowski; R. Jedrzejczak (pp. 343-344).
Glossary of analytical terms (IX)
by E. Prichard; H. Albus; B. Neidhart; W. Wegscheider (pp. 348-349).