SMIMA1101U QA, QC, GXP for Pharmaceutical Production
Master's Programme in Industrial Drug Development - compulsory
See course calendar for course dates on the webpage
for Master of Industrial Drug
Compulsory for Master of Industrial Drug Development (MIND) students, elective for Master of Pharmaceutical Regulatory Affairs (MPRA) students and other part-time master's students at the Faculty of Health and Medical Sciences (subject to study board approval). Open for freelance students who meet the admission criteria.
There is a need for an effective pharmaceutical quality system
to enhance the quality and availability of medicines around the
world in the interest of public health. We aim to give an overview
of existing legislation related to quality systems, and further, on
the efficient implementation of such systems.
The course is intended for MIND students, MPRA students and other drug development professionals who are working within drug development and manufacturing related activities, and who need basic knowledge about legislation within drug development.
The course contains a proper review of the relevant national and international legislation followed by lectures on how the pharmaceutical industry implements the quality system for practical use. The structure and content of a quality manual is described. Also the QA and QC activities for companies with marketed products are presented with the main focus on GMP.
- International legislation GXP (meaning GLP, GCP, GMP and GDP): EU, FDA, PIC/S, ICH, OECD
- National legislation GXP: Medicines Act, Executive orders on marketing authorisation, quality, labeling, manufacture, distribution and handling.
- Manufacturers authorization, authorization to handle euphoriant substances. Company quality manual: Policies, guidelines, SOP's, work instructions.
- QA/QC activities (GMP): Site master file, Audit of suppliers; self-inspection; deviation and change control systems; third party audits; authority inspections; handling of complaints and recall; qualification/validation activities including document approval and authorization; SOP's approval and authorization; GXP training and documentation; harmonization of GXP activities within a company (laboratories/production); specifications; release of packaging materials; release of starting materials; release of API (Active Pharmaceutical Ingredients); release of finished products; certificates of analysis (COA); Certificate of Compliance (COC).
- QA/QC activities (GCP and GLP): Monitoring and audits.
- QA/QC activities (GDP)
- Participation in industries association working groups discussing new legislation and harmonization of QA/QC activities, national and international.
The main objective of the course is to obtain a broad insight into the legislation and guidelines governing quality assurance (QA) and quality control (QC) and their implementation in the manufacture of medicinal products.
Upon completion of the course, participants are expected to be able to:
- Summarise the processes related to QA/QC activities in GXP (e.g. GLP, GCP, GMP and GDP) environment
- Demonstrate a basic knowledge about the relevant national and international legislation related to quality systems
- Demonstrate a basic knowledge about quality demands during development of medicinal products from research until distribution.
- Apply legislation related to quality systems and to other quality areas into practical cases
- Work in a regulated environment
- Identify relevant quality regulations and guidelines
- Extract relevant and practically useful information from legislation related to quality systems
- Exchange knowledge with other drug development professionals when implementing basic quality principles in practice
- Integrate quality thinking throughout the drug development process from the earliest research studies to marketing of a medicinal product.
The common course syllabus is a collection of legislation, presentations (hand-outs in electronic format) and cases, approximately 250 pages. Reference to the legislation will be sent to participants before the course, and the handouts of presentations (USB stick) will be given to the student during the course.
- A relevant bachelor degree or equivalent
- 2 years of relevant job experience
- Proficiency in English
- Theory exercises
Application deadline is 8 weeks before the first day of
Apply directly on the programme's webpage
- 2.5 ECTS
- Type of assessment
- Written assignmentEssay based on a selected case study and the common course syllabus. The essay must be approximately 5 pages.
- Exam registration requirements
Active participation in the course is a prerequisite for assessment.
- All aids allowed
- Marking scale
- passed/not passed
- Censorship form
- No external censorship
- Exam period
To be announced at the MIND programme's webpage
To be announced at the MIND programme's webpage
Criteria for exam assesment
To pass the exam the student should be able to demonstrate that they have achieved
- to summarise the processes related to QA/QC activities in GXP (e.g. GLP, GCP, GMP and GDP) environment
- to apply legislation related to quality systems and to other quality areas into practical cases
- to extract relevant and practically useful information from legislation related to quality systems
- Course code
- 2.5 ECTS
- Part Time Master
- 5 days
- See course calendar
- Course capacity
- 25 participants
- Course is also available as continuing and professional education
- Study board
- Study Board for the Professionel Master´s Degree Programmes at The Faculty og Health and Medical Science
- Department of Pharmacy
- Faculty of Health and Medical Sciences
- Natalja Genina (14-7c6f826f7a786f3c75737c777c6f4e81837c723c79833c7279)
Annette Byrholt Hansen, Danish Medicines Agency
Antony Pham, SPLY
Birthe Emilie Nielsen, Genmab
Bjørg Sandberg, H. Lundbeck A/S
Henriette Vindmar, pK Chemicals
Kathrine Hallas Dyhr, Pharmakon
Nusret Asanovski, GXP PharmAid
Tanja Lund Erichsen, Danish Medicines Agency
Tina Brouer, Pharmakon
The list may be subject to change.