Industrial Pharmacy Game: production and control

Course Code :2010FBDFGO
Study domain:Pharmaceutical Sciences
Academic year:2019-2020
Semester:2nd semester
Sequentiality:Cannot be followed with 2nd bachelor courses
Contact hours:106.5
Credits:8
Study load (hours):224
Contract restrictions: Exam contract not possible
Language of instruction:Dutch
Exam period:exam in the 2nd semester
Lecturer(s)Kenn Foubert
Paul Cos
Nina Hermans
Adrian Covaci
Filip Kiekens

3. Course contents *

The course contains several parts. In the first part different techniques and procedures to prepare and clean up samples will be discussed. An overview of the different columns available for HPLC and GC is given. The second part deals with analysis in different field, e.g. toxicology, microbiology, bromatology and pharmacognosy. In the part on the registration file, the requirements on the analytical part are summed up. The last part of the course is dedicated to quality control and validation. Quality guidelines, field of application and evaluation services are discussed. Method validation is thought during the practical course and seminars. International guidelines on validation are discussed, equipment is checked and methods are validated. The results obtained are evaluated by means of statistics (Excel).The course contains several parts. In the first part different techniques and procedures to prepare and clean up samples will be discussed. An overview of the different columns available for HPLC and GC is given. The second part deals with analysis in different field, e.g. toxicology, microbiology, bromatology and pharmacognosy. In the part on the registration file, the requirements on the analytical part are summed up. The last part of the course is dedicated to quality control and validation. Quality guidelines, field of application and evaluation services are discussed. Method validation is thought during the practical course and seminars. International guidelines on validation are discussed, equipment is checked and methods are validated. The results obtained are evaluated by means of statistics (Excel-SPSS).