C5920 Good Laboratory Practice

Faculty of Science
Autumn 2016
Extent and Intensity
1/0/0. 1 credit(s) (plus extra credits for completion). Type of Completion: zk (examination).
Teacher(s)
prof. RNDr. Luděk Bláha, Ph.D. (lecturer)
doc. Ing. Branislav Vrana, PhD. (lecturer)
Guaranteed by
prof. RNDr. Jana Klánová, Ph.D.
RECETOX - Faculty of Science
Contact Person: prof. RNDr. Jana Klánová, Ph.D.
Supplier department: RECETOX - Faculty of Science
Timetable
Mon 19. 9. to Sun 18. 12. Wed 11:00–12:50 D29/347-RCX2
Prerequisites
Introductory course on Analytical Chemistry or an equivalent, basic knowledge in biology.
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
At the end of the course, students will be able to:;
- understand major principle assuring quality of the analytical results both in chemistry and biology. ;
- discuss goals of GLP, fundamental terms and standards. ;
- describe, discuss and interpret organisation of laboratory and work conditions, laboratory accreditation and proficiency testing. ;
- conduct equipment validation, validation of analytical system. ;
- apply fundamentals of good sampling practice including techniques for homogeneous and nonhomogeneous objects, design and evaluation of sampling plan with emphasis on environmental sampling. ;
- understand needs of GLP application in practices (e.g. in biology such as safety assessment of chemicals for humans and the environment, microbiology and biochemistry, GMO etc.)
Syllabus
  • I. GLP principles and goals. Historical background, quality assurance and quality management. II. Key provisions. Organisation of laboratory, conditions. III. Laboratory accreditation. ČSN EN ISO/IEC 17025 Standard, terminology. IV. Proficiency testing. Methodology. V. Validation and testing. Validation of equipment, method, analytical system, and data. VI. Validation of analytical methods. VII. Estimation of performance characteristics. Documentation of an analytical method. VIII. Evaluation of results in respect to limit values. Control charts. IX. Principles of good sampling practice. Homogenous and heterogeneous objects, randomized and segregated objects. Sampling errors and sampling plan. X. Sampling techniques. Homogeneity test. Sampling of nonhomogenous objects. Assurance of sampling randomness. Systematic sampling of nonhomogenous materials. XI. Design and evaluation of a sampling plan. Evaluation of sampling precision and correctness. Documentation of sampling. XII. Environmental sampling.
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
Teaching methods
lectures (weekly)
Assessment methods
Students are evaluated by a written test(30 open questions, 50% success is required as minimum for further evaluation - 15-30 points are reflected in final result E-A).
Language of instruction
Czech
Further comments (probably available only in Czech)
Study Materials
The course is taught annually.
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 2001, 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 2017, Autumn 2018.
  • Enrolment Statistics (Autumn 2016, recent)
  • Permalink: https://is.muni.cz/course/sci/autumn2016/C5920