Quality Assurance in Supply Chain Management of Medicines

Course programme

Introduction

Ensuring the quality of medicines is a major public health concern. The emergence of substandard and counterfeit medicines, coupled with inefficient supply chain systems, not only poses a risk of negative health outcomes but also leads to economic losses and lack of trust in the health system. To address these issues and develop evidence-based strategies, it is important that people at all levels, from policy makers to primary healthcare workers appreciate and comprehend the need for effective QA systems.

This course will introduce you to the concepts and main principles of quality assurance, and will develop further skills and knowledge in different aspects of quality assurance such as pharmaceutical regulation, pharmaco-vigilance and quality control of medicines.

Course objectives

After having successfully completed the course, participants will be able to:

  • Define the key concepts and principles of quality assurance.
  • Comprehend the importance of quality assurance systems for medicines.
  • Describe how different functions of supply chain management affect the quality of medicines.
  • Explain the significance of shelf life and differentiate between types of stability studies.
  • Underline the key issues and challenges surrounding quality assurance systems especially in low and middle income countries.

 

What are the target participants?

The course is designed for personnel working in health programmes, health organisations, or national health systems who have an interest in, and will benefit from knowing more about quality assurance of medicines (procurement offices, supply and logistics divisions, regulatory bodies, hospitals, health facilities). There are no specific prerequisites for enrolling in this course. However, prior knowledge about supply chain management or pharmaceuticals will be an advantage.

Teaching and learning strategy

This online course requires the students to engage in self-directed learning and go through the course materials on the learning platform with the support of an online facilitator. Taking part in discussion forums, exchanging ideas with fellow participants and doing self-evaluation through online quizzes form a vital part of the learning experience.

In addition, there are several short assignments to guide the learning process of the participants, offering feedback on the submissions and an opportunity to interact with the facilitator. Assignment responses should be submitted within the respective due dates.

Assessment and grading

Participants will be graded based on their online participation and completion of activities. A certificate of completion and an e-badge will be awarded to all those who complete a minimum of 75% of all online activities (lessons, quizzes, discussion forums). The percentage of completion will be measured automatically online as the participant goes through the course.

In addition, participants need to obtain a passing mark of minimum 7/10 on the post-test.

Course duration

4 weeks

Level of effort: 4 hours per week

Course schedule

Week 1

Importance of quality assurance
Medicines regulation
Week 2

Ensuring quality in the manufacturing process
Ensuring quality of medicines during procurement
Week 3

Ensuring quality along the supply chain
Medicines quality control testing
Week 4

Stability studies and shelf life determination
Pharmacovigilance
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