In this brief video, Teresa Riccioni discusses the application of a risk assessment to set appropriate microbiological plate conditions per the new EU GMP Annex 1 draft, Rev 12. It starts with the new Annex 1 draft requirements to use a risk assessment, and then an interpretation on how to apply it and use it in different stages of the manufacturing process.
Learn more about this and other Annex 1 draft, Rev 12 updates or our Particle Measuring Systems’ Cleanroom Contamination Control Advisory Services.