Good Laboratory and Manufacturing Practice   (417B2)

Academic year:

2023/2024.

Attendance requirements:

There are no requirements.

ECTS:

5

Study level:

Study program:

Teacher:

Marija Đ. Gavrović Jankulović, Ph.D.
full professor, Faculty of Chemistry, Studentski trg 12-16, Beograd

Assistants:

—

Hours of instruction:

Weekly: three hours of lectures (3+0+0)

Goals:

The goal of this course is to help students to acquire knowledge on the basic principles of good laboratory practice and good manufacturing practice.

Outcome:

To enable student to apply principles of good laboratory practice and good manufacturing practice.

Teaching methods:

Lectures, seminars.

Extracurricular activities:

Visit of the company with implemented good manufacturing practice.

Coursebooks:

• GOOD LABORATORY PRACTICE (GLP) Quality practices for regulated non-clinical research and development, WHO, 2nd Ed.
• The GMP Handbook: A Guide to Quality and Compliance, Brendan Cooper, ISBN-10: 1548370258

Additional material:

—

Lectures:

10 points (3 hours a week)

Syllabus:

Students will learn the principles of good laboratory and manufacturing practices through the following lectures:

1. Introduction to Quality Management;
2. Quality Management System ISO 9001;
3. The basic application requirements of good manufacturing practice (GMP);
4. The basic application requirements of Good Laboratory Practice (GLP);
5. Resources for the application of standard quality (plant, equipment, reagents, materials);
6. Assay standards and testing;
7. The standard operating procedures;
8. Reporting System, preparation and disposal of documents.

Semester papers:

20 points

Oral exam:

70 points