9 replies to this topic

[Njaquino]

Hey everyone! I was audited yesterday and was docked for not having a complete MMR. The auditor said I needed a description of my process on it. Can someone please help me by providing a template? I created one based of the CFR code but I am missing somethings and I am not sure how to add in the descriptions and IP controls. We are new to DS and have created an IPSSC (Id, purity, strength, contamination, and composition) chart. 

[dstout]

Do you have more information? What controls do you have in place for making sure MMR's are approved prior to production runs? What was the root cause of the NC?

[Charles.C]

Hey everyone! I was audited yesterday and was docked for not having a complete MMR. The auditor said I needed a description of my process on it. Can someone please help me by providing a template? I created one based of the CFR code but I am missing somethings and I am not sure how to add in the descriptions and IP controls. We are new to DS and have created an IPSSC (Id, purity, strength, contamination, and composition) chart. 

 

 

^^^(red x 4) - Translation ??

[AlwaysMyFirstDay]

Hi! This might be my time to shine, i so rarely get to contribute since dietary supplements and the FDA are rarely discussed here 

 

without taking a look at your documents/formatting, it sounds like you didn't have a procedure/process that describes your manufacturing process. Its a fairly easy NC to handle. 

 

As far as your request, it's a bit tough to give you a template. you have to show YOUR process, after all. If you have any R&D personnel, they likely have a procedure that they wrote up which you can use as a starting point.

[Njaquino]

Do you have more information? What controls do you have in place for making sure MMR's are approved prior to production runs? What was the root cause of the NC?

 

Yes sorry! We have COA approvals and quarterly checks of purity, identification, contamination, and strength of the raw material. In place, we have weight checks of the dietary supplements and verification sign off by management. All finished product is sent for testing to check for concentration. 

[Njaquino]

^^^(red x 4) - Translation ??

 Yes, oh gosh I typed the question right after the auditor left.

 

IP- In process

MMR- Master manufacturing record; which is strange to me because the auditor made it sound like a registry instead of a record.

DS- dietary supplement

IPSCC- Identity, purity, strength, contamination and concentration  

[Njaquino]

Hi! This might be my time to shine, i so rarely get to contribute since dietary supplements and the FDA are rarely discussed here 

 

without taking a look at your documents/formatting, it sounds like you didn't have a procedure/process that describes your manufacturing process. Its a fairly easy NC to handle. 

 

As far as your request, it's a bit tough to give you a template. you have to show YOUR process, after all. If you have any R&D personnel, they likely have a procedure that they wrote up which you can use as a starting point.

 

I know that why I was struggling on where to ask . They said we had everything just not in one place.

 

I added our flow chart steps into a document that has all the dietary supplement, finished goods etc. 

 

So is the MMR a record or a registry because we have it as a record but the auditor was making it sound like a registry. When I asked them if it is a registry they said yes. But we were using it as a record... OMG WHAT DID I GET MYSELF INTO lol 

[AlwaysMyFirstDay]

I've got a great deal of minutia written down below, but i will write up here that the MMR could certainly be both a registry and record. it's basically your master formula for a given product. your batch records would be derived from the MMR. 

 

It does sound like you're working with all the right pieces, I'm quite familiar with the difficulty in putting them together in a way that makes sense.

 

my company composes the MMR similarly how i think others would have their batch records. It's designed quite plainly. we have the following pieces of information on ours:

• Name of product
• Lot#
• Batch size (in g or kg or both)
• complete list of raw materials used in product
• their associated quantities (% formulation or actual weight or both)
• a section for actual weight of input
• %difference
• Lot numbers for raw materials
• production/quality initials+date
• Additional pages which include procedure/instructions

 

This is all formatted into a simple Excel table.

 

A few other components which were required after a previous inspection's NC 5 years ago:

 

• total weight (of actual batch/production)
• %Yield
• The company logo present on each page. 

 

Don't panic! even the inspector said you had everything, its just not organized in a manner they like. From the comments I've read here over the past year, i think everyone agrees that an inspector can be as arbitrary and capricious as they like, we just all hope we get a fair shot or are able to argue our way out of unfair NCs. You got this! 

[dstout]

AlwaysMyFirstDay nailed it! 

[Njaquino]

I've got a great deal of minutia written down below, but i will write up here that the MMR could certainly be both a registry and record. it's basically your master formula for a given product. your batch records would be derived from the MMR. 

 

It does sound like you're working with all the right pieces, I'm quite familiar with the difficulty in putting them together in a way that makes sense.

 

my company composes the MMR similarly how i think others would have their batch records. It's designed quite plainly. we have the following pieces of information on ours:

• Name of product
• Lot#
• Batch size (in g or kg or both)
• complete list of raw materials used in product
• their associated quantities (% formulation or actual weight or both)
• a section for actual weight of input
• %difference
• Lot numbers for raw materials
• production/quality initials+date
• Additional pages which include procedure/instructions

 

This is all formatted into a simple Excel table.

 

A few other components which were required after a previous inspection's NC 5 years ago:

 

• total weight (of actual batch/production)
• %Yield
• The company logo present on each page. 

 

Don't panic! even the inspector said you had everything, its just not organized in a manner they like. From the comments I've read here over the past year, i think everyone agrees that an inspector can be as arbitrary and capricious as they like, we just all hope we get a fair shot or are able to argue our way out of unfair NCs. You got this! 

 

Thank you so much!!! That explanation was perfect! It really helped guide me!