94281 - Laboratory Assessment

Learning outcomes

At the end of the course the student will be aware of the relevance of laboratory analysis and assessment. The student will acquire a knowledge of reference materials and procedures for best laboratory assessment. In order to make data valid for general purposes, the student will become aware of the GLP (Good Laboratory Practice) regulation. The student in will be able to: 1. statistically elaborate analytical data; 2. set and maintain conditions to comply with GLP requirements; 3. perform laboratory intercomparison and manage reference testing materials.

Course contents

This CU is composed of three modules:

(1) Good laboratory Practice

Good laboratory practices to be followed by the Pharmaceutical Industry providing advice on the quality management system of the laboratories for an efficient functioning of the laboratory. Compliance with regulatory agencies’ guidelines and inspections management. Personnel responsibilities and training. Facility requirements. Materials management, specification requirements, stability evaluation, packaging materials, reference and retention samples, supplier qualification. Equipment qualification, characteristics selection, test required and documentation. Analytical method development, validation, transfer and verification for process support. Technology transfer documentation. Contract laboratories management and quality agreement. Computerized system validation, usage, and continuous verification. Data governance, GDP, ALCOA+ principles. Investigation on out of specification, out of trend, deviation, claim, recall, return of products. Quality Risk management application and tools used for evaluation.

(2) Reference Materials and Proficiency Testing Schemes
Different types of reference materials available and its proper use in an analytical laboratory, both in the validation step of an analytical method and in different steps of the laboratory quality control system (internal and external quality control). The preparation steps involved in production of RMs as well as all the analytical work required for homogeneity and stability tests. Different types of intercomparison exercises and the different steps involved in the organization of a PT scheme. The minimum statistical tools for the evaluation of the technical competence of a laboratory participating in a PTS will be introduced.

(3) Chemometrics

Multivariate exploratory analysis: Principal Component Analysis. The concept. Interpretation: information about samples (scores), variables (loadings) and relationships among them. Preprocessing and outlier detection. Application to environmental data and to industrial process control.

Multivariate calibration: Partial Least Squares regression. The concept. Model complexity and quality parameters. Qualitative interpretation of the calibration model. Application to environmental data and to industrial process control.

Readings/Bibliography

Lecture notes and selected papers will be available for students.

Recommended reading:

• James N. Miller, Jane C. Miller, “Statistics and Chemometrics for Analytical Chemistry”, 4th ed., Prentice Hall, 2000.
• Proficiency Testing in Analytical Chemistry. R.E. Lawn, M. Thompson, R. F. Walker. Royal Society of Chemistry. LGC (Teddington), 1997. ISBN: 0-85404-432-9.
• Practical statistics for the analytical scientist. A bench guide. T. Farrant. Royal Society of Chemistry. LGC (Teddington), 1997. ISBN: 0-85404-442-6

Teaching methods

The course unit is divided in three modules taught independently at different times in the academic year.

Each module is organized in theoretical classes where main concepts are explained, as well as tutorial classes with discussion of case-study examples.

Assessment methods

Each module is assessed independently through homework assignments (20%) and a written assignment (80%).

The Curricular Unit grade will be the arithmetic mean of grades from the three modules.

Office hours

See the website of Susana Amezqueta Perez

See the website of Drinalda Mehja

See the website of Ana Maria De Juan Capdevila