FRM3010 – Formulation, Production, and Control of Sterile Pharmaceutical Preparations
Schedule, syllabus and examination date
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.
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.
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
- FRM1000 – Pharmaceutical Chemistry, Part I (discontinued)
- FRM1010 – Pharmaceutical Chemistry, Part II (discontinued)
- FRM1020 – Pharmacy and the society (discontinued)
- FRM1030 – Bioorganic Chemistry
- FRM1040 – Foundation biology for pharmacists
- FRM1050 – Drugs and How They Work Part I
- FRM2000 – Drugs and How They Work Part II
- FRM2010 – Quality Control of Pharmaceutical ingredients
- FRM2020 – Production, Quality Control and Distribution of Medicinal products
- FRM2030 – Quality Assurance in Drug Production
- FRM2040 – Use of Drugs, Part I
- 3 credits overlap with FARM2150 – Formulation of Drugs and Quality Assurance in Drug Production.
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.
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.
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: