FRM3010 - Formulation, Production, and Control of Sterile Pharmaceutical Preparations

Schedule, syllabus and examination date

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Course content

FRM3010 gives a thorough introduction into basic formulation, production, quality assurance and microbiological quality control of aseptic and sterilized pharmaceutical preparations, including essential regulations and guidelines.

Learning outcome

After completing the course we expect your competence to include the following:

  • A thorough understanding of formulation, preparation, quality assurance, microbiological quality control and determination of shelf-life of sterile pharmaceutical products, as well as essential regulations and guidelines
  • An overview of structure, formulation and preparation of various biological pharmaceutical products and microbiological aspects essential for the preparation of sterile pharmaceutical products
  • On your own be able to prepare documentation, plan and conduct preparation of selected pharmaceutical preparations and microbiological quality control of the products and evaluate and validate the preparation procedure
  • Have a reflected approach to implementation of product quality as an integrated part of the production process

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 FRM2010 and FRM2030 must be passed and all manditory activities from FRM2020 and FRM2040 must be approved.
In order to sit for the exam: alle earlier Pharmacy courses up to and through FRM2040 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, laboratory work, demonstrations, group work, seminars, as well as an excursion when possible. The work in the laboratory is compulsory and makes an important part of the course. The laboratory work involves production of sterile pharmaceutical preparations and microbiological quality control of finished products. In order for the laboratory work to be approved, the student must participate at compulsory lectures and complete all the laboratory work concerning drug production and quality control. The laboratory work related to production of sterile pharmaceutical preparations needs to be approved in order for the student to be eligible to take the practical exam. The laboratory work in microbiological quality control of sterile pharmaceutical preparations needs to be approved in order for the student to be eligible to take the final 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

On and a half (1 ½) hours practical examination in the production of sterile pharmaceutical preparations, which is graded Passed / Not passed.
Three (3) hours final written digital exam, which is graded from A – F.

The exam in the production of sterile pharmaceutical preparations needs to be passed in order for the student to be eligible to take the final written exam.

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 scale from A to F, where A is the best grade and F is a fail. 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 autumn

Examination

Every autumn

Teaching language

Norwegian