Subject description for 2024/25
Pharmaceutical Manufacturing
FAR1014
Subject description for 2024/25

Pharmaceutical Manufacturing

FAR1014
In the Pharmaceutical Production course students are given an introduction to the formulation, manufacture and quality assurance of pharmaceuticals.
Theory and understanding of the theoretical principles relating to the composition and production of pharmaceuticals are included in order to provide a basis for pharmaceutical knowledge. The Pharmaceutical Production course will provide students with basic theoretical knowledge and the necessary practical skills to produce a variety of pharmaceuticals in accordance with the specified requirements and guidelines. In addition to the practical skills relating to pharmaceutical production, emphasis will be placed on control systems, accuracy and hygiene. In the course, students will be given the opportunity to display their knowledge, reflections and accuracy, as well as their use of relevant reference works/literature.
The course is reserved for students in the Bachelor's Programme in Pharmacy.
The Laboratory Safety course must be approved in order to gain access to the course’s laboratory course.

Knowledge

The student

  • has broad knowledge of production methods relating to a range of different types of pharmaceuticals
  • is familiar with relevant types of pharmaceuticals and excipient preparations
  • has knowledge of the key characteristics of a range of the pharmaceuticals and excipient substances used in pharmacy production, as well as their labelling and storage.
  • has knowledge of the rules and recommendations relating to the excipients and types of pharmaceuticals used in pharmacy production, e.g. those relating to pH, degree of fineness, temperature influences, etc.

Skills

The student

  • is able to employ their professional knowledge to identify forms of preparation - and reflect on the importance of these for a preparation
  • is able to apply their academic knowledge (theoretical and practical) to reflect on various pharmaceutical production procedures and thus be able to conduct impact assessments (advantages and disadvantages) in respect of various production choices
  • is able to use labelling rules and guidelines - as well as nomenclature
  • is able to use sources and referencing techniques for academic writing
  • is able to find, use and refer to monographs and standard operating procedures (SOP) in the production and/or reformulation of pharmaceuticals, and comply with current storage regulations, requirements/rules and recommendations
  • is able to practice and reflect on the use of quality assurance systems and possess knowledge of the requirements relating to production hygiene, accuracy and order of production (GMP)
  • is able to master relevant calculations in connection with the production and use of pharmaceutical products

General competence

The student

  • has insight into the statutes and regulations relating to the supply, labelling and manufacture of pharmaceuticals
  • is able to use relevant works of reference and academic literature
  • is able to convey academic pharmaceutical material in Norwegian, both written and orally, to the users of pharmaceuticals, colleagues and other personnel in the health and healthcare sector

In addition to the semester fees and course literature, students are expected to provide their own laptops, web cameras and headphones.

Students must obtain their own laboratory coats and a calculator approved for the study programme. Students must have their own shoes that are only used in the laboratory.

Compulsory theoretical course

Teaching takes place on campus. Some teaching may be done online.

It is required that students themselves become actively involved in their learning process. Individual work accounts for a high percentage of the course workload.

The following learning activities are used during teaching:

Online lessons/lectures Worksheet review under supervision

Coursework requirements with practical and theoretical sections: laboratory exercises with compulsory attendance and associated literature studies with written submissions

Course attendance is compulsory. Compulsory attendance is necessary to ensure that students achieve the learning outcomes described for the course (skills and general competence).

Compound assessement, grading scale Passed / Not Passed.

All parts described below must be approved/passed in order to receive a final grade in the course.

  • Assessment task, comprises 0/100 of the grade, grading scale Approved/ Not approved.
  • Compulsory participation -80%, comprises 0/100 of the grade, grading scale Approved/ Not approved.
  • Compulsory participation -80%, comprises 0/100 of the grade, grading scale Approved/ Not approved.
  • Practical examination, comprises 100/100 of the grade, grading scale Passed / Not Passed.
Approved calculator