QA, QC, GXP for Pharmaceutical Production

Course 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: 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.
Education

Master's Programme in Industrial Drug Development - compulsory

 

See course calendar for course dates on the webpage for Master of Industrial Drug Development  

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.

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.

The course is organised as an intensive 5-day course comprising lectures, discussions, cases and group discussions.

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.

Applicants must meet the following criteria:
- A relevant bachelor degree or equivalent
- 2 years of relevant job experience
- Proficiency in English

Collective
ECTS
2,5 ECTS
Type of assessment
Written assignment
Essay based on a selected case study and the common course syllabus. The essay must be approximately 5 pages.
Aid
All aids allowed
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assessment

To pass the exam the student should be able to demonstrate that they have achieved

Knowledge

  • to summarise the processes related to QA/QC activities in GXP (e.g. GLP, GCP, GMP and GDP) environment

 

Skill

  • to apply legislation related to quality systems and to other quality areas into practical cases

 

Competence

  • to extract relevant and practically useful information from legislation related to quality systems

Part time Master and Diploma courses

  • Category
  • Hours
  • Lectures
  • 19
  • Preparation
  • 30
  • Theory exercises
  • 19
  • Exam
  • 2
  • English
  • 70