Course Description:
This six-hour course provides best practices for bioanalytical and analytical laboratories that support the quality control of vaccines. The course offers fundamentals on analytical method validation, requirements for pharmaceutical microbiology laboratories, water systems, animal testing, equipment calibration and maintenance in a GMP laboratory. Using the recombinant hepatitis B vaccine as a case study, participants will be introduced to WHO guidelines that support vaccines as well as common tests that support the safety, identity, strength, purity, and quality of different types of vaccines. Expectations for stability studies that support the shelf life, labeling, and distribution will also be reviewed as they relate to USP general chapters.
Upon completion of this course, you will be able to
- Summarize and discuss WHO Technical Report Series, 961, 2011 Annex 2 good manufacturing practices for pharmaceutical microbiology laboratories.
- Explain expectations for qualification, maintenance and calibration of laboratory equipment in a good manufacturing practices environment.
- Describe detailed requirements for analytical method validation commonly used to release vaccines.
- Summarize and discuss WHO good manufacturing practices for Water for Pharmaceutical Use. WHO TRS 970, Annex 2 including qualification and control of water systems.
- Identify and discuss common tests used to ensure safety and efficacy of vaccines during each stage of production. State the typical tests required to release Hepatitis B vaccine.
- List the USP chapters and content that support vaccine manufacturing, quality control, stability testing, and potency assays.
- Summarize ICH Q5C – Stability Testing of Biotechnological / Biological Products - WHO/BS/06.2049 - Final Guidelines on Stability Evaluation of vaccines
Who should participate:
- R&D Manufacturers
- Research Scientists
- Biotechnology Manufacturers
- Pharmaceutical Microbiologists
Access Duration:
Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
USP Approved Instructor
Victor Maqueda
USP Consultant
Biologist/Professor of Biological Sciences
Maura C. Kibbey
USP Staff
Senior Scientific Fellow, Global Biologics
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