Università degli Studi di Urbino Carlo Bo / Portale Web di Ateneo


GLP-GMP mutuato
GLP-GMP

A.Y. Credits
2021/2022 6
Lecturer Email Office hours for students
Diego Puglié
Teaching in foreign languages
Course with optional materials in a foreign language
This course is entirely taught in Italian. Study materials can be provided in the foreign language and the final exam can be taken in the foreign language.

Assigned to the Degree Course

Biotecnologie mediche per la diagnostica e la terapia (LM-9)
Curriculum: BIOTECNOLOGIE PER LE TERAPIE INNOVATIVE
Date Time Classroom / Location
Date Time Classroom / Location

Learning Objectives

During the course we will deal to  the problems and tools useful for a controlled management of analytical and production methods . Specifically, will be identified the  principles  to the definition and control of the relative processes, the reference standards and the relative prescriptions, the certification and recognition system . The course is organized in frontal  lessons including exercises aimed  to preparing and applying the tools for managing the process variables 

Program

1. Quality product  levels

2. Quality minimum level of  and related protections: adaptive and proactive standards


3. Process quality as  quality product guarantee : management systems


4. The management criteria of process variables.


5. The  documentation principle and  prescriptive documents construction 


6. The voluntary and institutional certification-accreditation paths.

7. The requirements of a codified quality management system: the ISO 9001 standard

8. GMPs in the pharmaceutical sector: EU guidelines

9. Validation and qualification.

10. Controlled process management as an analytical results guarantee : Good Laboratory Practices.

11. Analytical data quality criteria and voluntary accreditation: ISO / IEC 17025

12. The “mandatory” GLPs for  research quality : Legislative Decree 50/2007 and OCSE guidelines

Teaching Material

The teaching material prepared by the lecturer in addition to recommended textbooks (such as for instance slides, lecture notes, exercises, bibliography) and communications from the lecturer specific to the course can be found inside the Moodle platform › blended.uniurb.it

« back Last update: 09/06/2022

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