C5920 Good Laboratory Practice

Faculty of Science
Autumn 2001
Extent and Intensity
1/0/0. 2 credit(s). Recommended Type of Completion: k (colloquium). Other types of completion: zk (examination).
Teacher(s)
doc. RNDr. Aleš Hrdlička, CSc. (lecturer)
Guaranteed by
doc. RNDr. Aleš Hrdlička, CSc.
Chemistry Section – Faculty of Science
Prerequisites
Introductory course on Analytical chemistry or an equivalent
Course Enrolment Limitations
The course is also offered to the students of the fields other than those the course is directly associated with.
fields of study / plans the course is directly associated with
Course objectives
Subject and goal of GLP are introduced, fundamental terms and standards are quoted. Organisation of laboratory and work conditions, laboratory accreditation and proficiency testing are discussed. Following part deals with equipment validation, validation of analytical system and those of analytical methods as well as with performance characteristics of analytical method and evaluation of results. In a closing part, fundamentals of good sampling practice inclusive of sampling techniques for homogeneous and nonhomogeneous objects, design and evaluation of sampling plan with emphasis on environmental sampling are given. Besides general topics and terms, the course is oriented to the field of analytical chemistry / environmental analytical chemistry.
Syllabus
  • I. Subject and goal of GLP. Historical background, legislation, ISO 9000 Series of international standards, quality assurance, quality systems, quality management. II. Key provisions. Organisation of laboratory, conditions. Study director, quality assurance unit, personnel. Standard operating procedures, reagents and solutions, control, reference and test articles, raw data, archiving, equipment, calibration standards, study conduction. Enforcement of GLP and GALP. III. Laboratory accreditation. EAL, EUROLAB, EURACHEM, accreditation in the Czech Republic, Czech Institute for Accreditation and external accreditation bodies, laboratory accreditation and certification. ČSN EN 45001 Standard and its place in the system of standards dealing with accreditation and certification, terminology. IV. Proficiency testing. National programme of proficiency testing, process, methodics, z-score, RSZ and SSZ values. V. Validation and testing. Validation of equipment, method, analytical system, and data. Equipment validation, validation certificate, examples of equipment validation, validation of separation techniques, parameters, system-suitability test, quality verification in routine analysis. VI. Validation of analytical methods. Features of the methods used for monitoring and control of chemical contamination, standardized methods vs. methods chosen by the laboratory. Terminology. VII. Estimation of performance characteristics. Process and goals, summary of characteristics. Principles of analytical procedure development, aim of analytical procedure vs. scope of validation. Documentation of analytical method. VIII. Evaluation of results in respect to limit values, positive and negative results, quantitation of false results, limit of decision, certainty curves. Results assessment from its repeatability and reproducibility, critical difference. Control charts. IX. Principles of good sampling practice. Sample, quality of sample, object quality. Homogenous and heterogeneous objects, randomised and segregated objects. Sample, increment, subsample. Sampling errors and sampling plan. X. Sampling techniques. Sampling of homogenous objects, F-criterium, homogeneity test. Sampling of nonhomogenous objects, random sampling, layer (class) sampling, cluster sampling, intracluster correlation coefficient. Multistage sampling. Assurance of sampling randomness. Systematic sampling of nonhomogenous materials, variance of sampling and time constant, autocovariation function. Estimation of inevitable sample number - sampling of segregated objects, multistage sampling, layer sampling. XI. Design and evaluation of a sampling plan. Evaluation of sampling precision, estimation of sampling variance, possible modifications of sampling plan. Evaluation of sampling trueness, blanks. Sample handling, storage, and transport. Documentation of sampling, acceptance of sample to analysis. XII. Environmental sampling. Study design, pilot study. Sampling means and number of samples, number of repeats. Sampling techniques, potential environmental distribution, sampling quality control.
Literature
  • CROSBY, N. T. and F. E. PRICHARD. Quality in the Analytical Laboratory. Chichester: J. Wiley, 1995. Analytical Chemistry by Open Learning (Series). ISBN 0 471 95470 5. info
  • MESTEK, O. and L. NONDEK. Zásady správného odběru vzorků pro analýzu životního prostředí (Principles of Good Sampling Practice in Environmental Analysis). Praha: Eurachem - ČR, 1995. Kvalimetrie, 4. ISBN 80-901868-0-7. info
Assessment methods (in Czech)
přednášky, týdně, písemný test, kolokvium
Language of instruction
Czech
Further comments (probably available only in Czech)
The course is taught annually.
The course is taught: every week.
Listed among pre-requisites of other courses
The course is also listed under the following terms Autumn 2007 - for the purpose of the accreditation, Autumn 1999, Autumn 2010 - only for the accreditation, Autumn 2000, Autumn 2002, Autumn 2003, Autumn 2004, Autumn 2005, Autumn 2006, Autumn 2007, Autumn 2008, Autumn 2009, Autumn 2010, Autumn 2011, Autumn 2011 - acreditation, Autumn 2012, Autumn 2013, Autumn 2014, Autumn 2015, Autumn 2016, autumn 2017, Autumn 2018.
  • Enrolment Statistics (Autumn 2001, recent)
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