Course Description:
This course consists of two main components: (1) a theory session and (2) a hands-on session. The theoretical portion begins with a brief history of the GPHF -Minilab and its impact on simple drug quality verification. Participants will learn about applying the Three-Level Approach, the limitations of the Minilab as a screening technology, and best practices for its use. The course also covers the step-by-step process for drug quality screening, including Minilab operations such as visual inspection, sample weight verification, simple disintegration testing, thin-layer chromatography, and proper waste management.
In the hands-on session, participants will have the opportunity to perform screening tests on selected medicines using the Minilab, gaining practical experience in identifying substandard and falsified (SF) medicines.
Pricing varies. Please inquire for more info at https://go.usp.org/Services.
Upon completion of this course, you will be able to
- Discuss the purpose and use of the Minilab in post-marketing surveillance programs.
- Explain the Three-Level Approach and multi-level testing decision process.
- Describe the benefits of using the Minilab in national surveillance programs.
- Explain the process for screening the quality of medicines using the Minilab.
- Demonstrate the ability to perform screening tests on medicines using the Minilab.
- Identify, report, and take appropriate action on suspected SF medicines.
Who should participate:
- National regulatory authorities
- National control laboratories