67190 - Management of Quality Sistem

Learning outcomes

At the end of the course the student has the knowledge and the fundamentals, both theoretical and practical, related to system quality, Quality Control, Certification and Accreditation according to the national and international standards (ISO 9000:2000 and ISO 17025: 2000) and the requirements of Good Laboratory Practice (GLP Good Laboratory Practice GLP) and Good Manufacturing Practices. The student is able to handle specific laboratory activities for the application of chemical control methods in the various stages of production and validation studies of drugs and health products, according to the standards of certification and accreditation. The student has knowledge on microbial contamination in the pharmaceutical industry and the main microbial assays used to monitor the quality of pharmaceutical preparations traditional and biological and biotechnological products.

Course contents

Analytical Chemistry: An introduction and test on Analytical Chemistry concepts. Aims. Glossary. Certified reference materials. Statistical processing of analytical data. Chemiometry.

History of the Quality System.

Quality System ISO 9000:2000 Series of Standards,  necessary for all three modules of the integrated course and introductory to the course itself.

Quality System: compulsory and voluntary requirements; National and European guidelines. Quality management. Certification, advantages for enterprises and authorities. ISO 9000:2000 Series of Standards. ISO 17025 Series of Standards. Quality System and Accreditation. Quantifying Uncertainty in Analytical Measurement (EURACHEM/CITAC Guide CG 4, 2000). Good Quality Laboratory Practice (GQLP or BPLQ). Standard Operative procedures. Usage and maintenance of instrumentation. Quality in Analytical Chemistry, An Aid to Accreditation (CITAC/Eurachem Guide, Edition 2002) The Quality Assurance Program in the laboratory. Quality and safety integration in the laboratory. SINAL and SIT agencies. Sample management and data recording in the laboratory. The Quality Manual. Quality control and inspection. Inspection planning, development and report. Quality and Environment: The ISO 4000 Series of Standards and their application. Social Accountability SA 8000.

The Quality System in a hospital analysis laboratory: Introduction to Quality in a laboratory of Clinical Chemistry. The Quality System in a laboratory of Clinical Chemistry and its peculiarity. Institutional accreditation. Emilia-Romagna Accreditation Law (LEGGE REGIONALE 12 ottobre 1998, n. 34#LR-ER-1998-34#).

Quality Control in the Food and Dietetic products industries. Quality Control instruments. Inspections planning. The evolution of Quality Control and Quality Assurance.

Quality System in a Laboratory of Environmental Analysis: Advantages from the introduction and application of the Quality System. Quality problems. Methodologies to define the costs for the introduction and application of the Quality Service. Experiences of accreditation and certification.

Quality System in a Food Factory.

Quality System in an Analysis Laboratory of Pharmaceutical Factory.

 

ModuleControl of products and processes.
Credits: 3; TOTAL HOURS: 24. Teacher: Dr. Diego Pugliè.
The course will address the issues and tools for a controlled management of production methods. Specifically, the principles will be identified for the definition and control of the processes, the reference standards and related requirements, the system of certification and recognition. The classes will be front type and practical activity will be on application management tools of the variables of a process.
1. Levels of product quality
2. Minimum level of quality and relevant safeguards: adaptive and proactive standards
3. The quality of the process as a guarantee of product quality: management systems
4. The management criteria of the variables of a process.
5. The traceability principle and the construction of prescriptive documents
6. The voluntary and institutional certification-accreditation ways-.
7. The requirements of a standard quality management system: the ISO 9001:08.
8. Procedures for managing continuous improvement: Internal Audits, Non-conformity and AC/AP
9. Criteria concerning data quality and voluntary accreditation: ISO / IEC 17025:05-Accreditation of systems and of analytical methods
10. Overview of other Management Systems for the impact of Ethics (SA 8000), Environmental Management Systems (ISO 14000) and Occupational Health and Safety (OHSAS 18001)
11. The GMP in the pharmaceutical sector: EU guidelines
12. The controlled management of the process as a guarantee of analytical results: the Good Laboratory Practices for the quality of the research: the D.Lgs.50/2007 and OECD guidelines.
Textbooks: Appendix legislation provided by the teachers including:
• D.Lgs.50/07
• Dir.CE 2003/94
• Guidelines on EC GMP
• annex 15 GMP guidelines
• ISO 9001:08
• ISO-IEC 17025:05

Readings/Bibliography

The material presented in class is made available to the student in electronic format via Internet, to obtain educational materials: http://campus.unibo.it/ (restricted access to students enrolled at the University of Bologna ).
The course material and notes taken in class are essential for the exam.

- Guide CITAC.

- ACCREDIA Documents.
Appendix legislation provided by professors, including:

·       D.Lgs.50/07

·       Dir.CE 2003/94

·       Linee Guida CE su GMP

·       annex 15 linee guida GMP

·       ISO 9001:08

·       ISO-IEC 17025:05

As a reference, the student can possibly deepen the arguments of one of the following texts:

- Fausto Fantini, Laura Cattani “Q&A, Principi di Qualità”, Pitagora Editrice, Bologna, 2003.

- Helmut Günzler “Accreditamento e Assicurazione Qualità in Chimica Analitica”, Springer, 1994.

- Kaoru Ishikawa “Guida al controllo di qualità”, Franco Angeli Editore, 1995.

- " Fondamenti di Chimica Analitica Quantitativa", Daniel C. Harris (Zanichelli Editore, Bologna, 2017).

- "Fondamenti di Chimica Analitica di Skoog e West”, F. J. Holler, S. R. Crouch (Edizione: III, EdiSES, S.r.l., Napoli, 2015).

- "Chimica Analitica, teoria e pratica", F.W. Fifield, D. Kealey (Zanichelli Editore, Bologna, 1999).

- "Elementi di Chimica Analitica", Daniel C. Harris (Zanichelli Editore, Bologna, 2005).

- "Chimica Analitica Quantitativa", Daniel C. Harris (Zanichelli Editore, Bologna, 2017).

- “Chimica Analitica e Analisi Quantitativa”, D.S. Hage, J.D. Carr, (Piccin Nuova Libraria SpA, Padova, 2012).

- "Chimica Analitica Strumentale", F.J. Holler, D.A. Skoog, S.R. Crouch, (EdiSES, S.r.l., Napoli, 2009).

- "Chimica Analitica: una Introduzione", D.A. Skoog, D.M. West, F.J. Holler, (EdiSES, S.r.l., Napoli, 1996).

- "Esercizi per la Chimica Analitica, con richiami di teoria", S. Araneo, (Progetto Leonardo, Esculapio, Bologna, 2012).

- Santucci Umberto Fai luce sulla chiave. Problem setting: l'arte di definire i problemi prima di risolverli L'Airone Editrice, Roma, 2007, 207 p.

Teaching methods

Lectures in which they are presented and discussed the topics of the course, with exercises explanatory. Seminars. Self-evaluation test. Discussion of bibliographic research carried out and the application of the scientific method to a case / real research.

Assessment methods

The assessment of learningtakes place only through the final exam, which ensures the acquisition of knowledge and skills expected by conducting an oral interview and the resolution of numerical problems of the entire program, on both modules, which can be broken down into moments of verification separated. The marks obtained in the two modules are then combined to obtain the final grade of the final exam by weighted means and hare valid for one year.

The exam takes place only through the final exam, which ensures the acquisition of knowledge and skills expected of the entire program, on both modules, which can be broken down into moments of verification separated. The marks obtained in the two modules are then combined to obtain the final grade of the final exam weighted means and have a maturity of annual validity.

Form Application of the quality system: The assessment of learning occurs through a process of self-assessment questionnaire end of the entire program, which ensures the acquisition of knowledge and skills expected. In order to take the examination must demonstrate the ability to perform a literature search, discussing the results of this test, which will be preparatory to the continued consideration. The evaluation criterion is based on the demonstration by the student to be able to use and apply the knowledge, information and cultural tools provided by the course. The threshold of sufficiency of learning is represented in particular by the demonstration of critical understanding and ability to discussion of the topics of the course.

The questionnaire will be used for individual assessment only for students / students present on the agreed date, the other students may submit appeals officers to take the exam ONLY oral form of the course, bringing literature search and presentation of the scientific method applied to a real case.

Control Module of products and processes: The assessment of learning occurs through the oral examination of the entire program. The evaluation criterion is based on the demonstration by the student to have learned the basic concepts and potential impact at the application level management models discussed during the course. The threshold of sufficiency of learning is represented in particular by the demonstration of critical understanding and ability to discussion of the topics of the course.

Teaching tools

Video projector, PC, Internet and You Tube links.

Links to further information

http://www.unibo.it/docenti/stefano.girotti

Office hours

See the website of Stefano Girotti

See the website of Diego Pugliè