Metrology and Analytical Validation

Recommended Prerequisites

The recommended knowledge fall under knowledge, technical skills achieved in course units, General Chemistry Organic Chemistry, Analytical Chemistry and Instrumental Methods of Analysis to successfully achieve the objectives of this course unit.  

Teaching Methods

Lectures with a strong component of dialogue using visual media.  Discussion of case studies described in the recommended bibliography by professors.  With regard to continuous evaluation, it includes teamwork, problem solving, cases studies; participate in discussions, research reports and 2 tests laid down in the Regulation Pedagogical.

Continuous assessment of Laboratory Component with presentation of reports of all laboratory works and discussion of real cases. Implementing a laboratory activity.

Learning Outcomes

The Metrology is the science of measurement, includes theoretical and practical aspects that guarantee the quality of products and services. From the practical point of view includes the calibration of measurement instruments and test validation. So, one of the goals of this course is to give students the basic concepts of metrology required for routine work in a laboratory of analysis: development of concepts related to the strategy and implementation of analytical validation, analytical methods, validation study phases, the application of Good Laboratory Practice, evaluation and treatment of critical points, development of protocols and reports validation and revalidation, in accordance with recent EU guidelines.

 Application of analytical methods and their validation to ensure their compliance with the intended use, as well as capacity building to implement new analytical methods in order to follow the present underlying dynamics of a laboratory.

Work Placement(s)

No

Syllabus

Definition of metrology and metrological control. History in Portugal of metrology. Role of the Portuguese Quality Institute in metrological control. Role of Bureau International des Poids et Mesures (BIPM) in the global metrological control: Metro Convention, the BIPM functions.Role of the advisory committees of the BIPM. Rules for spelling of names and symbols for units and the expression of SI values and quantities. Consultation of the International Vocabulary of Metrology (VIM) for correct application of the terms in laboratory reports. Measurement uncertainty. Importance of verification, calibration and adjustment of measuring instruments. Analytical validation of analytical methods. Key concepts and terminology. Validation parameters: selectivity, specificity, sensitivity, detection and quantification limits, accuracy, precision, robustness and stability. Acceptance criteria. Certified analytical materials. Revalidation. Official methods of reference. European regulations.

Head Lecturer(s)

Angelina Lopes Simões Pena

Assessment Methods

Continuous Assessment
Other: Attendance: 5.0%
Synthesis work: 20.0%
Laboratory work or Field work: 30.0%
Mini Tests: 45.0%

Final Assessment
Exam: 100.0%

Bibliography

Analytical method validation and instrument performance verification. Ed Wiley Interscience 2004.
Guideline Bioanalytical method validation.EMA. London, 2011.
Note for guidance validation of analytical procedures methodology /(CPMP/ICH/281/95), London.
Guidance for industry. Bioanalytical method validation, U.S Department Health and Human Services, FDA,USA, 2013.
Decisão Comissão CE/657/2002-Desempenho de métodos analíticos e interpretação dos resultados
Vocabulário Internacional de metrologia (2008) ed IPQ
Vocabulário Internacional de metrologia Legal (2009) ed. IPQ
SI Brochure: The International System of Units (SI), 8th ed, 2006; updated 2014
http://www.bipm.org/en/publications/si-brochure/
E. Batista, e col.Calibração of micropipettes: test methods and uncertainty analysis; measurement 2007;40:338
José Henrique e col. Química Nova, 2002vol25:111.
Guia para quantificação de incerteza em ensaios químicos (publicação PAC) 2007.
Metrologia Industrial 2011, Pedro Guedes ed ETEP.