Influenza vaccines – Quality module
Recently, EMA (European Medical Agency) published a Guideline on Influenza Vaccines – Quality Module. Though the main focus of this EMA guideline was not QbD or PAT, one section – 4.1.1.6. Characterisation – was relevant to QTPP, CQA, CPP and hints on the details of the design space (albeit...
What Matters to Patients? QTPP for Vaccines: A-Vax Case Study
Many of you asked for the QbD Risk Assessment Template for Vaccines. We are happy to announce that it is now available. CMC-Vaccines Working Group published a QbD case study: A-VAX: Applying Quality by Design to Vaccines in 2012. The QTPP-CQA-CPP/CMA template is based on this A-Vax case study....
QbD for Vaccines: A-Vax Control Strategy [Slides]
If you are applying QbD for Vaccines, this presentation will be helpful. Dr. Hyun Sung Kim presented a summary of A-VAX case study at KOBIA 2014. Dr. HS Kim (HS from hereon) is the Quality Director at Green Cross, Korea. I share my notes with you. As with any...