A
amyjpowers
Hello, Cove!
I'm working for a company that is in the process of making OTC ointments and creams. We are well on our way to complying to cGMP regulations. I'm finding parts of 21 CFR 211 a little confusing at times.
Is it safe to think of a charge-in component (211.101) as the FDA approved monograph?
Is it safe to define Control of Components and Drug Product Containers and Closures (211.80) as:
Components=raw materials, including the FDA approved monograph, that is manufactured into the ointment/cream
Drug product containers=the tube/jar that the ointment/cream goes into.
Thank you for your support.
Closures=the cap that goes on the tube/jar.
I'm working for a company that is in the process of making OTC ointments and creams. We are well on our way to complying to cGMP regulations. I'm finding parts of 21 CFR 211 a little confusing at times.
Is it safe to think of a charge-in component (211.101) as the FDA approved monograph?
Is it safe to define Control of Components and Drug Product Containers and Closures (211.80) as:
Components=raw materials, including the FDA approved monograph, that is manufactured into the ointment/cream
Drug product containers=the tube/jar that the ointment/cream goes into.
Thank you for your support.
Closures=the cap that goes on the tube/jar.