Complaint SOP (Standard Operating Procedure)

[Jeff EORL]

Hi, have not been here in a while, but good day to you all. I have 2 questions.

1) If you are compliant with 21CFR's 820 are you also in compliance with GMP? If not what do you need to do to have both? I cannot figure it out. Too much stuff!

2) I am currently reviewing our Complaint Handling SOP, does anyone have an Complaint Handling SOP for a medical device company they could share as a reference/sample?

Thanks for all your time.

Jeff

 

[WalkingSeed]

Sorrry I don't have a Complaint SOP for medical devices. One the first question, remember that lower case 'c' meaning "current" that often sits in front of GMP. You need to keep your finger on the pulse of what the FDA is currently looking for / finding by reviewing the 483's and warning letters that appear on their web site.

 

[Ajit Basrur]

Hi, have not been here in a while, but good day to you all. I have 2 questions.

1) If you are compliant with 21CFR's 820 are you also in compliance with GMP? If not what do you need to do to have both? I cannot figure it out. Too much stuff!

2) I am currently reviewing our Complaint Handling SOP, does anyone have an Complaint Handling SOP for a medical device company they could share as a reference/sample?

Thanks for all your time.

Jeff

In addition to WalkingSeed response,

1. Yes, when you comply with 21 CFR Part 820, you comply to GMP but you need to stay "current" and hence the cGMP.

2. Probably, if you could share your current one, we could comment and provide inputs

 

[Jeff EORL]

Thank you for your response. I will see about posting our current SOP here for comments...great idea.

When you say "current" and cGMP, what does current mean? if we comply with the current CFR's 820 then are we cGMP?

Thanks
Jeff

 

[sadananda_pvc]

Hi,
This is the process, we have been following.

Hope this may .....

Sada

 

[WalkingSeed]

Thank you for your response. I will see about posting our current SOP here for comments...great idea.

When you say "current" and cGMP, what does current mean? if we comply with the current CFR's 820 then are we cGMP?

Thanks
Jeff

The CFR's are the law and therefore do not change very often. These are the basis for GMP's. Audits performed by the FDA may reveal inconsistencies within the industry where companies A, B, C, D and E are all performing some process the same way. Then, at company F the FDA finds that they are performing the same process only differently and the results they obtain with their process are suspect and a 483 is issued. Suddenly through the magic of administrative action the method that A, B, D, D, and E employ is the defacto standard and company F is out of compliance. No law has changed, but the expectation has.

I think about the requirement that used to exist that no organic carbon be detectable in WFI. We installed new inline TOC analyzers which were about 100X more sensitive than the old ones. Suddenly we were detecting organic carbons.
Are we now out of compliance with the GMPs or does something in the USP need to change?

The USP changed and therefore the cGMP. A maximum threshold for TOC was established and all manufacturers of parenteral drugs suddenly need to update their TOC analyzers to be in compliance with the USP and therefore the law because there is now a need to measure and report TOC to a specific threshold.

 

[sagai]

Hi!

Read ( )this first :
http://www.fda.gov/medicaldevices/d...rements/qualitysystemsregulations/default.htm

and do not forget this one also (it has a horrible styling bytheway for me):
http://www.fda.gov/downloads/Medica...dicalDeviceQualitySystemsManual/UCM122806.pdf


21CFR820 itself is the cGMP (GMP if u like less precisely) and it does set requirements for complaint handling.

br
Sz.


ps.:
Ohhh ... there is also a interesting reading, search for complaint in this case within.
http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074883.htm

ps.:
FOIA is the one I like

 

[dcraig]

I could be wrong but as I just scanned it quickly but I do not think this would pass an FDA audit. I see no where in your process do you identify if there is patient involvement or anything asbout MDR or vigilence reporting requirements.

 

[Jeff EORL]

Thanks for all your posts. I have attached our SOP for complaint handling if any of you have time can you please take a look and let me know any areas we are lacking or can improve on.

 

[sagai]

may be useful, br
Sz.