FRM2030 – Quality Assurance in Drug Production
Course description
Schedule, syllabus and examination date
Course content
The course provides a thorough introduction to small-scale production of medicinal products. Quality assurance and documentation are important elements, associated regulations and guidelines are included in the course.
Learning outcome
After completing the course we expect your competence to include the following:
- a thorough understanding of the principles of quality assurance and the importance of having a quality assurance system.
- a thorough understanding of basic operations and methods in small scale production.
- be able to plan and manufacture selected dosage forms on a small scale.
- master to employ the quality systems in the manufacturing of medicinal products and independently document the production according to current regulations and guidelines.
- become considerate towards a pharmacist's responsibility in the manufacture of medicinal products.
Admission
The course is only available to students enrolled at the School of Pharmacy at the University of Oslo.
Prerequisites
Formal prerequisite knowledge
In order to participate in this course and sit the exam all earlier Pharmacy courses up to and through FRM2010 – Quality Control of Pharmaceutical ingredients (discontinued) must be passed.
Health, Safety and Environment (HSE)
There are compulsory HSE courses at the beginning of the first semester. For students commencing their program from the autumn semester 2015 the following courses are mandatory:
- HMS0501 - Safety and Physical Environment
- HMS0502 - Positive Learning Environment
- HMS0507 - Fire Safety
In addition to this you will have to complete HMS0503 - Laboratory Safety and HMS0506 Patient clinic Safety for participation in Laboratory and clinic-courses in the program.
You will need to provide documentation that you have passed HMS0501, HMS0502, HMS0503 HMS0506 and HMS0507 when you attend the first mandatory lab.
For students who commenced the program from the Autumn semester 2012 up til and including the spring semester 2015 the following courses are mandatory:
- MNHMS0015 - Introduction to Health, Safety and Environment (HSE) (discontinued) or HMS0501 - Safety and Physical Environment and HMS0502 - Positive Learning Environment and HMS0507 - Fire Safety.
- MNHMS0010LS - Introduction to Laboratory Safety (discontinued) or MNHMS0020LS - In-Depth Laboratory Safety (discontinued) or HMS0503 - Laboratory Safety
- MNHMS0015FS - Introduction to Field Safety (discontinued) or HMS0504 Field Safety.
For more information on the HSE courses and transitional arrangements:
http://www.mn.uio.no/english/studies/courses/hse-courses.html
Teaching
The course includes lectures, group work, seminars, laboratory work. The laboratory work is a substantial part of the course and will last for 7 weeks, with two or more laboratory days pr week. The laboratory work is compulsory.
The laboratory and project work, and the presentation of the project, need to be approved in order for the student to be eligible to take the written exam.
Inactivity and / or excessive absences in compulsory education means that the student does not receive final assessment / examination.
As the teaching involves laboratory and/or field work, you should consider taking out a separate travel and personal risk insurance. Read about your insurance cover as a student.
Access to teaching
A student who has completed compulsory instruction and coursework and has had these approved, is not entitled to repeat that instruction and coursework. A student who has been admitted to a course, but who has not completed compulsory instruction and coursework or had these approved, is entitled to repeat that instruction and coursework, depending on available capacity.
Examination
The exam is combined of a 2 hours written part and a 3 hours practical part. The written and practical parts of the exam are held the same day and are evaluated as a whole.
Examination support material
As of 1 August, 2016, the use of own calculators is no longer permitted. Casio FX-991EX calculators are handed out to all exam candidates at the beginning of the exam.
Grading scale
Grades are awarded on a pass/fail scale. Read more about the grading system.
Explanations and appeals
Resit an examination
This course offers both postponed and resit of examination. Read more:
Withdrawal from an examination
It is possible to take the exam up to 3 times. If you withdraw from the exam after the deadline or during the exam, this will be counted as an examination attempt.
Special examination arrangements
Application form, deadline and requirements for special examination arrangements.
Evaluation
The course is subject to continuous evaluation. At regular intervals we also ask students to participate in a more comprehensive evaluation.