FRM2030 - Quality Assurance in Drug Production

Schedule, syllabus and examination date

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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, all earlier Pharmacy courses up to and through FRM1050 must be passed and all manditory activities from FRM2000 and FRM2010 must be approved.
In order to sit for the exam: all earlier Pharmacy courses up to and through FRM2010 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:

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.

Facts about this course

Credits

5

Level

Bachelor

Teaching

Every spring

FRM 2020 and FRM 2030 in the same semester.

The curriculum is being revised. The course is taught for the last time spring 2018.

Examination

Every spring

Teaching language

Norwegian