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Dudes
We are a medical device manufacturer and must therefore fulfill 21 CFR 820. For one of our customers, we are going to manufacture a new product which should be registered as a drug. We should therefore implement 21 CFR 211 as well.
Does anyone have a good comparison of the 2 regulations? A list of the additional requirements to fulfill the cGMP would be really useful...
Does anyone have a good comparison of the 2 regulations? A list of the additional requirements to fulfill the cGMP would be really useful...