Hello,

We are classified as a "component manufacturer" through the FDA and are ISO 9001 & 13485 certified. The FDA scheduled an audit of our facility, within the first hour the inspector realized that we are indeed a component manufacturer and decided that the audit did not need to be completed. However, the auditor suggested that we become cGMP compliant...

So I've been researching... I came across a statement "if you are 13485 certified, you are cGMP compliant". Can anyone tell me if that is a true statement and recommend some type of training program or facility that we could look into?

Thank you in advance,
Amanda

Hello,

We are classified as a "component manufacturer" through the FDA and are ISO 9001 & 13485 certified. The FDA scheduled an audit of our facility, within the first hour the inspector realized that we are indeed a component manufacturer and decided that the audit did not need to be completed. However, the auditor suggested that we become cGMP compliant...

So I've been researching... I came across a statement "if you are 13485 certified, you are cGMP compliant". Can anyone tell me if that is a true statement and recommend some type of training program or facility that we could look into?

Thank you in advance,
Amanda


While the requirements of 13485 and cGMP have been harmonized to a great extent, there are still some differences, mainly regarding the cGMPs being more detailed and prescriptive. I would suggest you search the Post Attachments List or other sources to find a good comparison matrix and then conduct a gap analysis.

Hello,

We are classified as a "component manufacturer" through the FDA and are ISO 9001 & 13485 certified. The FDA scheduled an audit of our facility, within the first hour the inspector realized that we are indeed a component manufacturer and decided that the audit did not need to be completed. However, the auditor suggested that we become cGMP compliant...

So I've been researching... I came across a statement "if you are 13485 certified, you are cGMP compliant". Can anyone tell me if that is a true statement and recommend some type of training program or facility that we could look into?

Thank you in advance,
Amanda

Just because you are 13485 certified, you might not be cGMP. It depends on your certifying body. They were probably lenient and didn't want to give you any non-conformities. Did you receive any non-conformities from your certifying body? If not, that means you have been using the same certifying body.
Do you mind me asking if you received any non-conformities from the FDA Audit? If you did, then that means you are not cGMP compliant. According to the FDA , you have to become cGMP compliant.

While the requirements of 13485 and cGMP have been harmonized to a great extent, there are still some differences, mainly regarding the cGMPs being more detailed and prescriptive. I would suggest you search the Post Attachments List or other sources to find a good comparison matrix and then conduct a gap analysis.

Good advice, Doug. :applause::thanks:

Amanda, you may also want to check this web site http://www.gmp1st.com/ for more information on cGMPs.

Hope this helps. :bigwave:

Hello,

We are classified as a "component manufacturer" through the FDA and are ISO 9001 & 13485 certified. The FDA scheduled an audit of our facility, within the first hour the inspector realized that we are indeed a component manufacturer and decided that the audit did not need to be completed. However, the auditor suggested that we become cGMP compliant...

So I've been researching... I came across a statement "if you are 13485 certified, you are cGMP compliant". Can anyone tell me if that is a true statement and recommend some type of training program or facility that we could look into?

Thank you in advance,
Amanda

Amanda,

Our Fellow Covers Ted and Gidget have done great work:

Read their posts and attachments.

Look here (http://elsmar.com/Forums/showpost.php?p=201611&postcount=17) for post + attachment

Look here (http://elsmar.com/Forums/showpost.php?p=201616&postcount=18) for post + attachment

Stijloor.

Although both are related to the "quality systems" portion of the lifecycle regulations, as Doug pointed out, the cGMP is more prescriptive, meaning that they asks for more documentation (it was in some ways based on the old versions of quality systems standards which was more of a task-based documented SOP standards, very different from the process approach of the recent standards - ISO 13485 inclusive).

Also, there´s some fundamental difference in the approaches for "effectiveness" in the USa and "intented use" in ISO 13485 (which is based mainly on the EU point of view) which prevents them from being implemented and eudit as the same.

I wonder if the responses are missing the mark for the original post. Amanda indicates her company is a *component* manufacturer, not a finished device manufacturer. So what does cGMP compliance mean for a component manufacturer? Obviously the auditor didn't see the need for a thorough inspection. Are component manufacturers required to maintain DHRs and DMRs? Maybe there's no difference from a cGMP perspective?

I wonder if the responses are missing the mark for the original post. Amanda indicates her company is a *component* manufacturer, not a finished device manufacturer. So what does cGMP compliance mean for a component manufacturer? Obviously the auditor didn't see the need for a thorough inspection. Are component manufacturers required to maintain DHRs and DMRs? Maybe there's no difference from a cGMP perspective?

This is from the QSR Manual, "Current FDA policy is to rely upon the finished device manufacturer to assure that components are acceptable for use. Component manufacturers are not routinely scheduled for GMP inspections; however, FDA encourages them to use the QS regulation as guidance for their quality system".

I wonder if the responses are missing the mark for the original post. Amanda indicates her company is a *component* manufacturer, not a finished device manufacturer. So what does cGMP compliance mean for a component manufacturer? Obviously the auditor didn't see the need for a thorough inspection. Are component manufacturers required to maintain DHRs and DMRs? Maybe there's no difference from a cGMP perspective?

Component manufcturers have to be part of the quality system of the final device manufacturers because, dependening on the component, they can have a big impact on the final product. The "quality/risk management system parity" in which the suppliers are either part of the QS or have their own based on the the ones for the manufacturer is a trend in the industry.