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Hello,
I was wondering if I can get our CMC RAs expertise in regards to PPQ early termination of biologics.
1. Is PPQ early termination in biologics common?
2. From FDA/EMA's view, are there concerns about so many human errors happened during GMP production of one product?
3. Are there any justifications for not being a represent batch? all the early terminated or human error related failure can be justified as not a representative batch?
4. Is there any guidelines that i can educate myself more on human errors during PPQ?
Really appreciate your help.
Best