Tabular Gap Analysis of the EU (volume 4) and US (210/211) cGMP Regulations

[al in drug dev reg - 2010]

Hi, after extensive looking, I have failed to find a good tabular gap analysis of the EU (volume 4) and US (210/211) cGMP regulations.

I would specifically like to know what are the US cGMP requirements that are not a requirement in the EU

 

[harry]

Any takers for this question?

 

[Ajit Basrur]

Hi, after extensive looking, I have failed to find a good tabular gap analysis of the EU (volume 4) and US (210/211) cGMP regulations.

I would specifically like to know what are the US cGMP requirements that are not a requirement in the EU

Welcome to the Cove, al in drug dev reg

Regarding your question, I would like to mention from the FDA website the following -

As reported in the September 2003 announcement, FDA created a CGMP Harmonization Analysis working group to analyze internal and external CGMP requirements, including those related to quality systems. This working group performed a formal analysis of 21 CFR parts 210 and 211 against the GMPs of the European Union (EU), PIC/S, as well as other Agency CGMP regulations to identify the differences and consider the value of adding or changing the current regulations. Upon completion of their analysis, the working group concluded that there are many more similarities than differences among the various regulations. Where differences exist, the working group found that they can often be explained by unique aspects of the specific product subject to the regulation. For example, the device quality system regulation (21 CFR 820.200) requires that procedures for performing servicing be established and maintained by the manufacturer, where appropriate, which is an activity unique to devices. The EU GMPs have explicit requirements for separate areas for maintenance workshops and weighing of materials, whereas 21 CFR 211.42(c) requires that operations be performed within specifically defined areas of adequate size.

Based on the working group's analysis, the Agency decided to take an incremental approach to modifying parts 210 and 211 while pursuing international harmonization through ICH and PIC/S. The ultimate goals of the modifications will be to encourage timely detection and response to emerging defects or indications that product quality has been compromised; to provide further clarity and modernize the regulations; and to harmonize various aspects of parts 210 and 211 both internationally and with other Agency regulations.​

You could get more information at Analysis of cGMP Requirements

 

[al in drug dev reg - 2010]

Thanks Ajit,

Yes, I am familiar with the efforts to bring along harmonization, and truth be told, it is easy to read broader requirements in either regulation to align if desired. The real issue here is I am trying to determine how much risk I have in bringing an EU cGMP oral drug product contract manufacturer in compliance for a PAI. They have been inspected several times for EU cGMP but do not claim compliance to US cGMP and desire resources to become compliant.

The area I am finding more difficult is identifying specific items like pest control that requires an established procedure in the US but I am told by an EU cGMP mfg. that an established procedure it is not required in Europe if there is no issue with pests.

Another area that is standing out is temperature validations of equipment such as freezers. I reviewed temperature mapping studies and saw 4pt studies in a standard size refridgerator were acceptable to the EU inspectors but I would not expect that less than 12-14 point mapping to be acceptable in the US.

If anybody would like to help put this together in parallel, please let me know.

Again, thanks for your input Ajit and thanks for your prompt Harry/al