Charge-in Components - 21 CFR Part 211 Requirements Clarification

[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.

 

[Ajit Basrur]

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.

Yes, you are right.

The definition of "Component" is provided in 21 CFR Part 210 as -

(3) Component means any ingredient intended for use in the manufacture of a drug product, including those that may not appear in such drug product.

This includes both Active and inactive ingredient.

Have you seen the FDA Guidance document on Container Closure system (see attached) - thats a good reference ?

.

 

[amyjpowers]

Thank you, Ajit! I've been working hard for the past two years getting us compliant to the FDA QSR. When it was decided to add FDA approved monographs to our ointment I had no clue how much MORE hard work is ahead of me! This regulation is causing me to go bald on parts of my head! :mg:

I appreciate your support and I'm sure you will be hearing from me again. This site has been invaluable!

 

[Ajit Basrur]

Thank you, Ajit! I've been working hard for the past two years getting us compliant to the FDA QSR. When it was decided to add FDA approved monographs to our ointment I had no clue how much MORE hard work is ahead of me! This regulation is causing me to go bald on parts of my head! :mg:

I appreciate your support and I'm sure you will be hearing from me again. This site has been invaluable!

Glad to know that this site is helping you. Pls come back with your questions ... are are ready