FDA Compliance - CMC quality and regulatory issues & cGMP - 21CFR parts 210 and 211

[Douglas_D]

I am new to this site and was hoping to find more discussions concerning CMC quality and regulatory issues as related to cGMP federal regulations (specifically 21CFR parts 210 and 211). I work for a small virtual pharmaceutical company in the US and am working at developing quality systems and could use some strategic regulatory assistance. Does anyone know of any Forum they could direct me to that would be focused on this area.

Regards, D

 

[Scott Catron]

Re: FDA Compliance - CMC quality and regulatory issues & cGMP - 21CFR parts 210 and 2

I've been on the lookout for a forum you describe for years, but have not stumbled across one yet.

There's some folks here with experience with the FDA, so feel free to fire away.

Just for clarity - what is a "virtual drug company".

 

[Douglas_D]

Re: FDA Compliance - CMC quality and regulatory issues & cGMP - 21CFR parts 210 and 2

As a virtual pharmaceutical company you could in-liscense a potential drug candidate from a university and outsource the drug product development. The nonclinical and early phase clinical studies are performed by contract organizations. If you can demonstrate proof of concept and have a safe stable drug you can hopefully get a big pharma company interested as a partner to invest in the final development. This can all be done in an office environment with no labs or any equipment but you still have full compliance responsibility.

 

[Ajit Basrur]

Re: FDA Compliance - CMC quality and regulatory issues & cGMP - 21CFR parts 210 and 2

Sorry Douglas, I have not come across such forums but feel free to shoot your questions.

 

[jeyaseelan]

Re: FDA Compliance - CMC quality and regulatory issues & cGMP - 21CFR parts 210 and 2

Hello Douglas,

Please let me know your questions related to CGMP, 21 CFR Part 210 & 211. I have prior exp in implementing Quality systems. I will be able to help you.

Thanks.

 

[DonnaH]

Re: FDA Compliance - CMC quality and regulatory issues & cGMP - 21CFR parts 210 and 2

Hello,

I have a supplement manufacturer with a QMS designed for 21 CFR 110. They now need to move to 21 CFR 111. Does anyone know of a comparison/gap assessment checklist of changes from 110 to 111? I am building one, but the styles of the two docs are very different and it gets *messy* in a hurry.

Thanks in advance...