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What to expect during a GMP Audit


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#1 Cwanger

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Posted 16 June 2017 - 06:23 PM

Hey all

 

I am to be expecting our first GMP Audit within the next month. Can anyone give me any words of advice, or what to expect during the audit? This is a really nerve racking experience considering I just started the role as QC manager in March. Thank you all ahead of time!

 


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#2 cookieDking

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Posted 16 June 2017 - 08:27 PM

First of all make sure your documents are in order. Next tidy up of your building and last make sure your processing area is immaculate. But the key is documentation (HACCP plan, recall plan, pest control information and current pest control licenses...etc)

You will find auditors will be different as well, I recall my last auditor telling me that food wrappers and cups shouldn't be in the trash can, the next one looked right over it.


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#3 Charles.C

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Posted 17 June 2017 - 05:21 AM

Hey all

 

I am to be expecting our first GMP Audit within the next month. Can anyone give me any words of advice, or what to expect during the audit? This is a really nerve racking experience considering I just started the role as QC manager in March. Thank you all ahead of time!

 

Hi Cwanger,

 

Hopefully you have some food technical background ?

Whose GMP audit is it ?

 

@CookieD - I guess it "depends" but I would not expect a GMP audit to necessarily include haccp plans. I certainly agree with yr auditor comment. Regardless, thanks for the input and Welcome to the Forum !.


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Kind Regards,

 

Charles.C


#4 Cwanger

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Posted 19 June 2017 - 12:19 PM

Hello Charles.C,

 

I do have some food technical background but nothing to this extent. We are starting it all from the bottom as of now, with only 3 employees working in that part of the facility. The GMP audit will be done through ASI Food. 


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#5 Charles.C

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Posted 19 June 2017 - 12:30 PM

Hello Charles.C,

 

I do have some food technical background but nothing to this extent. We are starting it all from the bottom as of now, with only 3 employees working in that part of the facility. The GMP audit will be done through ASI Food. 

 

Hi Cwanger,

 

Thks yr response. Given yr time frame, you may need to urgently consider some professional assistance. The latter would handle all my next comments if you have not already done so. (And my apologies in advance if you know all about/have done my following comments already :smile:)

 

I'm not in the USA so no knowledge of ASI Food but I anticipate that their audit will be based on some specific accessible  Standard. Do you have it already ? If not, this = yr immediate necessity. (I anticipate that it will relate to the US CFR requirements but only guessing.)

 

Assuming you do have it, the usual next step is to do a Gap Analysis, ie mark, on a list of  the Standard's requrements, which elements you can already respond to. This then highlights the items which you need to immediately focus on.

 

Further comments IMO rather depend on yr current progress level and perhaps budgetary options.

 

PS - if you do have a copy of the ASI Standard, can you perhaps post it here for comments ?

 

PPS - there are a lot of US posters on this forum so some may know of the basis/expectations  of the ASI audit . Anybody ?


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Kind Regards,

 

Charles.C


#6 Cwanger

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Posted 19 June 2017 - 12:36 PM

Hello Charles.C,

 

I do already have their specific standard but it's based off of FSMA, and a lot of the columns say N/A on the end, so I don't know what is necessary and what is not. It contains 50+ pages and a lot has to be written documents. Unfortunately the company I am working for has never had a GMP audit only FDA or USDA audit. So most of their records are kept digital and does not consist of a written procedure, but more of the "honesty" rule.


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#7 Charles.C

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Posted 19 June 2017 - 12:54 PM

Hi Cwanger,

 

Does it include haccp requirements or not ? I personally would not expect such in a "GMP" audit.

 

(Offhand i find it difficult to envisage a 50 page standard solely on GMP unless it is highly user-friendly)

 

Surely a FDA audit also required a ton of written documents ?


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Charles.C


#8 Charles.C

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Posted 19 June 2017 - 01:07 PM

addendum

 

is this what you are referring to ?

 

http://www.asifood.com/gmp-audits.html


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Charles.C


#9 Cwanger

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Posted 19 June 2017 - 01:22 PM

Yes that is who is conducting the audit. The representative there himself had sent an excel spreadsheet with all the information, the 50+pages I was talking about. It does say they will be checking the HACCP plan, which is a headache in itself since we carry more then 4,000 SKU'S. I'm sure the FDA did call for a ton of written documents as well but not to this extent. 


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#10 Charles.C

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Posted 19 June 2017 - 02:00 PM

Yes that is who is conducting the audit. The representative there himself had sent an excel spreadsheet with all the information, the 50+pages I was talking about. It does say they will be checking the HACCP plan, which is a headache in itself since we carry more then 4,000 SKU'S. I'm sure the FDA did call for a ton of written documents as well but not to this extent. 

 

Hi Cwanger,

 

OK. i had a quick look at one of the downloadable forms (2017 food processing).

 

Looks more like a full-blown FS audit but I (also) failed to comprehend what all the red N/As mean (excluded for GMP ?, but that also did not make sense IMO). First question to somebody ??

 

As my previous Post, I suggest you do a Gap Analysis on the relevant form (there are several on dwl page).

 

Based on what you have stated so far, a time frame of one month sounds highly optimistic IMO, w/wo assistance.

 

The answer to yr OP rather depends IMO on yr Gap Analysis. For example, if you cannot yet comply with any of the haccp section, an audit seems rather pointless unless you are seeking official advice on what is lacking.

 

Maybe you can give an idea of how close you are to matching the "Checklist" ?


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Charles.C


#11 Tamale

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Posted 20 June 2017 - 02:14 PM

I just went through two GMP/AIB audits.

 

They focus a lot on plant cleanliness. The auditor will look constantly at ceilings and anything overhanging the products critical pathway. They usually carry flashlights and mirrors for looking under machines. So get a flashlight and inspect as they will.

 

If a contaminant is found in the critical pathway they may stop the audit for an automatic fail. They are usually lenient on documentation NC contrary to GFSI audits.

 

They also tend to look in unexpected places like the inside of ventilation units. Check for bugs, spider webs and the like. If you have rodent traps make sure they are well aligned against the wall.

 

They will look at employee sanitation practices, hand washing, hot water availability etc.

 

If you have any cracked plexiglass on your machines, change it.

 

Make sure your master cleaning schedule is well filled out and up to date.

 

Those are a few items, you'll get the hang of it!

 

Good luck sleeping the knight before the audit ;-)

 

Tamale

 


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#12 Charles.C

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Posted 20 June 2017 - 03:06 PM

Hi tamale,

 

Did you have a look at the potential checklist ?

 

If all relevant, it looks (to me) in a different league to AIB/GMP. (Unfortunately).


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Charles.C





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