Good Manufacturing Practice for Pharmaceuticals

Code:

269695

ECTS:

3.0

Lecturers in charge:

prof. dr. sc. Jasna Novak

Lecturers:

prof. dr. sc. Jasna Novak - Seminar

Take exam:

Studomat

Load:

1. komponenta

Lecture type	Total
Lectures	8
Seminar	16
Laboratory exercises	8

* Load is given in academic hour (1 academic hour = 45 minutes)

Description:

Adopting the basic principles, and mastering the skills and methods necessary for the successful implementation of good manufacturing practice that must be applied by manufacturers of finished drugs intended for marketing and drugs intended for clinical testing.

Learning outcomes:

Literature:

EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines, EudraLex, Elselvier,
Quality Rules: A Short Guide to GMP ., Jhon Sharp, The Pharmaceutical and Healthcare Sciences Society., 2009.
Biopharmaceutical processing: development, design, and implementation of manufacturing processes., G. Jagschies, E. Lindskog, K. Lacki, P. M. Galliher (ured.), Elselvier, 2018.

Prerequisit for:

Enrollment :
Passed : Biochemistry 2
Passed : Molecular Genetics

6. semester

Izborni predmeti grupe B -BT - Regular studij - Biotechnology

Consultations schedule:

Good Manufacturing Practice for Pharmaceuticals