VIDEO: Annex 1 and Using a Risk Assessment to Set Microbiological Plate Incubation Conditions

This short video 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.

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