SMIMA1101U QA, QC, GXP for Pharmaceutical Production

Volume 2015/2016
Education

Please note that this is the course description for the study year 2015/16. Information on course dates, prices etc. in coming semesters please visit www.mind.ku.dk

Master's Programme in Industrial Drug Development - compulsory

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.

Content

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.

Topics read:

  • International legislation GXP (meaning GLP, GCP, GMP and GDP): EU, FDA, PIC/S, ICH, OECD
  • National legislation GXP: Medicinal Products Act, Executive orders on marketing authorisation, quality, labeling, manufacture, distribution and handling, Euphoriant Act
  • Manufacturers authorization, authorization to handle euphoriant substances Company quality manual: Policies, guidelines, SOP's, work instruction
  • QA/QC activities (GMP): Site master file, Audit of suppliers; audits within the group; self-inspection; deviation and change control systems; third party audits; authority inspections; handling of complaints and recall including pharmacovigilance matters; 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.
Learning Outcome

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:


Knowledge

  • 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.


Skills

  • 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


Competencies

  • 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.
Literature

The course material is a collection of legislation, presentations (hand-outs) and cases, approximately 250 pages. Reference to the legislation will be sent to participants before the course, and the handouts of presentations will be given to the student during the course. The syllabus will be comprised of all 250 pages.

Applicants must meet the following criteria:
- A relevant bachelor degree or equivalent
- A minimum of 2 years of relevant job experience
- Proficiency in English
The course is organised as an intensive 5-day course comprising lectures in lectures, cases and group discussions.
  • Category
  • Hours
  • Exam
  • 2
  • Lectures
  • 19
  • Preparation
  • 30
  • Theory exercises
  • 19
  • Total
  • 70
Credit
2,5 ECTS
Type of assessment
Written examination, 2 hours under invigilation
Examination design: The purpose of the examination is to test that the examinee has achieved the learning objectives. The exam is a combination of multiple-choice questions and case studies. The percentage of items on the test devoted to a particular topic will roughly correspond to the emphasis given the topic in teaching of the course, as implied in the general course objectives and abstracts of the topics.
Aid
Written aids allowed

Apart from the standard programs and IT tools listed under The Faculty of Health and Medical Sciences at http://pc-exam.ku.dk/it_tools/health/ students will at this exam also have access to use a USB stick (for notes etc.)

Marking scale
7-point grading scale
Censorship form
External censorship
Exam period

11 December 2015 at 2-4 pm.

Re-exam

11 January 2016.

Criteria for exam assesment


The grade 12 is given when the participant:

  • combines convincingly the learned elements of the quality system
  • demonstrates with few unimportant deficits mastering of relevant terms and principles in the quality system.


The grade 7 is given when the participant:

  • documents a certain overview of the learned elements of the quality system
  • demonstrates with minor deficits a firm knowledge of relevant terms and principles in the quality system


The grade 02 is given when the participant:

  • demonstrates a limited overview of the quality system and ability to combine learned elements is limited
  • demonstrates only to a limited extent and with a number of deficits capability to handle relevant terms and principles of the quality system.