Hello,
We are a third party manufacturer registered with the FDA. One of our clients has asked us to manufacture just the bulk of an OTC product.
The customer, who is also registered with the FDA will fill their bulk and perform the necessary OTC stability testing.
Is it correct, that as the bulk manufacturer we are only responsible for assuring the bulk is manufactured according to CGMP, the process is validated and is in specification when it leaves our facility?
Thank you for advising,
Terry Van Liew
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