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

Schedule, syllabus and examination date

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Changes in the course due to coronavirus

Autumn 2020 the exams of most courses at the MN Faculty will be conducted as digital home exams or oral exams, using the normal grading scale. The semester page for your course will be updated with any changes in the form of examination.

See general guidelines for examination at the MN Faculty autumn 2020.

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 to the course

The course is only available to students who have been admitted to the Department of Pharmacy at the University of Oslo.

This is a transitional course that is open only to students admitted to the 5-year master's program in pharmacy through autumn 2016, and is transferred from old to new curriculum.

The course is not available for students admitted to the 5-year master's program in pharmacy from autumn 2017.  

Formal prerequisite knowledge

The compulsory HSE-courses HMS0501 – Safety and Physical Environment, HMS0502 – Positive Learning Environment, HMS0503 – Laboratory Safety, HMS0506 – Patient Clinic Safety and HMS0507 – Fire Safety.

Overlapping courses

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

Final written exam, 4 hours, which counts 100 % towards the finale grade. 

This course has mandatory exercises that must be approved before you can sit the finale 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.

Language of examination

You may write your examination paper in Norwegian, Swedish and Danish.

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.

Resit an examination

This course offers both postponed and resit of examination. Read more:

Special examination arrangements, use of sources, explanations and appeals

See more about examinations at UiO

Last updated from FS (Common Student System) Oct. 24, 2020 2:10:37 AM

Facts about this course

Credits
5
Level
Bachelor
Teaching
Autumn

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

Examination
Autumn
Teaching language
Norwegian