The 3 rd Virtual cGMP Training Marathon for Vaccine Manufacturing was delivered virtually by the LPA Unit in a newly designed format from 8 November to 8 December 2022. Part 1 delivered in-depth content on facility design, technology transfer and advanced concepts of GMP for quality vaccine production; Part 2 was a hands-on group work for a small group of participants to solidify their learning and skills using real-life scenarios and pre-selected Quality Risk Management tools. More than 1200 vaccine and biopharmaceutical manufacturers and officials from national regulatory agencies and government ministries/institutions from around 80 Member States in the six WHO regions successfully completed Part 1 of the training marathon.

The most frequent questions raised in Part 1 of the 3 rd Training Marathon have been assembled in this Question & Answer (Q&A) document with answers from GMP experts with long and rich experience in the pharmaceutical & biopharmaceutical industry, national regulatory authority, and other organizations. This is the 2nd Q&A document released for the series of Virtual cGMP Training Marathons organized by the LPA Unit; the 1st Q&A document was released following the Virtual cGMP Training Marathon for Vaccine Manufacturing in 2021. Its format allows the reader to easily refer to the questions under each specific session and topic. This is a continuous learning resource for participants and other relevant stakeholders to acquire new capacities to strengthen their local production of safe and quality vaccines.

Report by the World Health Organization