Syllabus for Good Manufacturing Practice

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Syllabus

  • 6 credits
  • Course code: 3DR404
  • Education cycle: Second cycle
  • Main field(s) of study and in-depth level: Medical Nuclide Techniques A1F

    Explanation of codes

    The code indicates the education cycle and in-depth level of the course in relation to other courses within the same main field of study according to the requirements for general degrees:

    First cycle

    • G1N: has only upper-secondary level entry requirements
    • G1F: has less than 60 credits in first-cycle course/s as entry requirements
    • G1E: contains specially designed degree project for Higher Education Diploma
    • G2F: has at least 60 credits in first-cycle course/s as entry requirements
    • G2E: has at least 60 credits in first-cycle course/s as entry requirements, contains degree project for Bachelor of Arts/Bachelor of Science
    • GXX: in-depth level of the course cannot be classified

    Second cycle

    • A1N: has only first-cycle course/s as entry requirements
    • A1F: has second-cycle course/s as entry requirements
    • A1E: contains degree project for Master of Arts/Master of Science (60 credits)
    • A2E: contains degree project for Master of Arts/Master of Science (120 credits)
    • AXX: in-depth level of the course cannot be classified

  • Grading system: Fail (U), Pass (G)
  • Established: 2007-08-22
  • Established by:
  • Revised: 2017-12-19
  • Revised by: The Master Programmes Board of the Faculty of Medicine
  • Applies from: Autumn 2017
  • Entry requirements:

    A Bachelor's degree, equivalent to a Swedish Kandidatexamen, from an internationally recognised university in life sciences (e.g. physics, radiophysics, chemistry or biology), medicine, pharmacy, nursing, or other relevant university education. Radiation Protection and Medical Effects, 6 credits.

  • Responsible department: Department of Immunology, Genetics and Pathology

Learning outcomes

After passed course it is expected that the student can

  • describe the basic concepts of Good Manufacturing Practice, especially those relevant for small-scale production of radiopharmaceutical compounds for use in humans
  • present formal requirements from authorities on GMP for medical drugs, laws and regulations for preparation of sterile drugs
  • describe the regulations for radiopharmaceuticals within the frames of clinical trials.
  • describe quality control, chemical and radiochemical identity and purity
  • describe microbiological quality control, aseptic production, localities, clothing etc.
  • describe quality assurance, design of quality systems, risk analysis and risk assessment
  • explain Good Clinical Trial Practice (GCTP) in theory and in clinical trials
  • describe Audit, monitoring, internal and external inspections
  • describe qualification and validation
  • carry out production under GMP and preparation of monographs, standard operating procedure, SOP, batch protocols, exercise in aseptic production and presentation and analysis of protocols.

Content

  • Good Manufacturing Practice: definitions, requirements and historical background
  • Quality assurance, quality management, design of quality systems
  • Principles for documentation in GMP

    Site Master File, SMF

    Monographs

    Protocols (production protocols, standard operating procedures, SOP)

  • Quality control, chemical and radiochemical identity and purity
  • Risk analysis and risk assessment
  • Clinical trials
  • Qualification and validation
  • Introduction to basic microbiology
  • Microbiological test and quality control
  • Aseptic production, localities, clothing
  • Audit, monitoring, internal and external inspections
  • Alternative quality systems (nationally and internationally)
  • Good Manufacturing Practice in clinical trials
  • Exercises; production of monographs and standard operation protocol, SOP, including exercise in aseptic production
  • Requirements for radiolabelled cell lines and proteins (seminar)

Instruction

Lectures, seminars and exercises/demonstrations. Course-specific web site information and education material.

Assessment

Oral examination at the end of the course. A passing grade for the entire course requires passing grade for the individual subprojects. The grades "Pass" or "Fail" are given.

If there are special reasons for doing so, an examiner may make an exception from the method of assessment indicated and allow a student to be assessed by another method. An example of special reasons might be a certificate regarding special pedagogical support from the University's disability coordinator.

Syllabus Revisions

Reading list

Reading list

Applies from: Autumn 2017

Some titles may be available electronically through the University library.

Literature

Handouts E-books available from UU (open access) Scientific papers

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