Educational guide

IDENTIFYING DATA

2024_25

Subject

CONTROL DE CALIDAD ANALITICA

Code

01737011

Study programme

1737 - MASTER UNIVERSITARIO EN PRODUCCION DE INDUSTRIAS FARMACEUTICAS

Descriptors

Credit.

Type

Year

Period

Compulsory

First

Second

Language

Castellano

Prerequisites

Department

QUIMICA Y FISICA APLICADAS

Coordinador

PEREIRA GARCÍA , FERNANDO JOSE

E-mail

fjperg@unileon.es
lcrobg@unileon.es

Lecturers

ROBLES GARCÍA , LUIS CARLOS

PEREIRA GARCÍA , FERNANDO JOSE

Web

http://

General description

The subject "Analytical Quality Control" is a fundamental course that lays the groundwork for understanding and properly applying the fundamental aspects of all stages comprising analytical control within the pharmaceutical industry.

Tribunales de Revisión

Tribunal titular
Cargo	Departamento	Profesor
Presidente	QUIMICA Y FISICA APLICADAS	MARTIN VILLACORTA , JAVIER
Secretario	QUIMICA Y FISICA APLICADAS	MARTINEZ MORAN , OLEGARIO
Vocal	QUIMICA Y FISICA APLICADAS	CARA JIMENEZ , JORGE

Tribunal suplente
Cargo	Departamento	Profesor
Presidente	QUIMICA Y FISICA APLICADAS	MORAN PALAO , ANTONIO
Secretario	QUIMICA Y FISICA APLICADAS	GOMEZ BARRIOS , XIOMAR ARLETH
Vocal	QUIMICA Y FISICA APLICADAS	SANCHEZ MORAN , MARTA ELENA

Competencies

Type A	Code	Competences Specific
	A17596
Type B	Code	Competences Transversal
	B5436
	B5437
	B5438
	B5441
	B5442
	B5443
	B5444
Type C	Code	Competences Nuclear
	C1
	C2

Learning aims

	Competences
The student applies acquired knowledge and solves problems in new or unfamiliar environments within broader (or multidisciplinary) contexts related to his/her expertise.			C1
The student integrates knowledge and tackles the complexity of formulating judgments based on information that, even when incomplete or limited, includes reflections on the social and ethical responsibilities associated with the application of their knowledge and judgments.			C2
The student evaluates possibilities for improving a production process or quality management from a technical standpoint.		B5436
The student has the decision-making capacity to implement the most suitable production and quality control systems according to social and economic needs.		B5437
The student is capable of managing facilities for the production of chemical and biological products that can improve human or animal health or living conditions.		B5438
The student performs and proposes sampling and analysis of a product or raw material.	A17596
The student makes decisions and solves problems by identifying them, locating their causes, considering alternative solutions, and selecting and evaluating the most suitable one.		B5441
The student possesses critical thinking skills, being capable of analyzing, synthesizing, and drawing conclusions from an article (whether opinion-based or scientific).		B5442
The student is creative and capable of innovating, possessing initiative, and fostering ideas and inventiveness.		B5443
The student manages time and resources, developes plans, prioritizes activities, identifies critical tasks, sets deadlines, and meets them.		B5444

Contents

Topic	Sub-topic
I. Quality Control	Lesson 1. Introduction to Drugs' Quality Control Lesson 2. The Analytical Method applied to Quality Control. Statistics support
II. Sample preparation	Lesson 3. Sampling and sample pretreatment
III. Chromatographic separations	Lesson 4. Chromatographic separations: HPLC, LC-MS
IV. Spectroscopic techniques	Lesson 5. Spectroscopic techniques: UV-Vis, NIR and FT-IR, Raman
V. Practical program: laboratory experimentation	The pretreatment of a pharmaceutical sample, to separate its components, and its chemical characterization and quantification will be performed applying one or various analytical techniques previously studied.

Planning

Methodologies :: Tests
	Class hours	Hours outside the classroom	Total hours
Problem solving, classroom exercises	7	10	17

Laboratory practicals	5	7	12

Lecture	15	23	38

Objective short-answer tests	2	0	2
Practical tests	1	0	1

(*)The information in the planning table is for guidance only and does not take into account the heterogeneity of the students.

Methodologies

Methodologies ::

	Description
Problem solving, classroom exercises	Formulation, analysis, resolution, and debate of a problem or exercise related to the subject matter of the course.
Laboratory practicals	Apply, at a practical level, the theory from a specific knowledge area within the context of pharmaceutical products.
Lecture	Presentation and discussion of the theoretical foundations of the course.

Personalized attention

Lecture

Problem solving, classroom exercises

Laboratory practicals

Description

The student has several pre-scheduled tutoring hours per week. However, the student also has the option to access the faculty by visiting their office during regular working hours to address doubts or any other questions.

Assessment

	Description	Qualification
Lecture	Objective exam with questions and exercises	6
Problem solving, classroom exercises		3
Laboratory practicals	Continued	1

Other comments and second call
The use and possession of electronic devices that enable communication (mobile phones, radios, etc.) are strictly prohibited. In the event of any irregularity occurring during the assessment tests, based on the corresponding current regulations, the exam will be confiscated, the student will be expelled from the test, and it will be graded as a fail.

Sources of information

Access to Recommended Bibliography in the Catalog ULE

Basic
	- J-M. Aiache, S. Aiache, R. Renoux. Introducción al estudio del medicamento. Barcelona: Ed. Masson, 1996. - M.J. Llopis Clavijo, V. Baixauli Comes. La formulación magistral en la oficina de farmacia. Valencia: Distribuciones Cid, 1997. - C. Barbé Rocabert. Preparados farmacéuticos y parafarmacéuticos. Barcelona: Ed. Masson, 2001. - D.C. Harris. Análisis Químico Cuantitativo. Ed. Reverté, 2001. - C. Cámara. Toma y tratamiento de muestras. Madrid: Ed. Síntesis, 2002. - D. Harvey. Química Analítica Moderna. Madrid: Ed. McGraw-Hill, 2002. - D.A. Skoog, D.M. West, F.J. Holler, S.R. Crouch. Fundamentos de Química Analítica. Ed. Brooks/Cole (Cengage Learning), 9ª, 2017. - D.A. Skoog, F.J. Holler, S.R. Crouch. Principios de Análisis Instrumental. Ed. Cengage Learning, 7ª , 2018. - International Conference on Harmonisation (ICH). Validation of Analytical Procedures, 2023.
Complementary

Recommendations