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Help with my master manufacturing record

Master Manufacturing Record

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detario

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Posted 01 September 2021 - 12:21 AM

I was just making a template for master manufacturing records template for the company I work for to help out production, and was hoping I could get some more eyes on what I have to see if it covers the minimum I would need.  Thank you!

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Scampi

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Posted 01 September 2021 - 01:09 PM

It would be helpful to have a general idea of what you're making

 

For my money, if this is a template for production to use---it's way to wordy

 

I'm actually a bit confused by it------part of it reads more like a final specification for your finished goods

 

What exactly are you wanting to create?


Please stop referring to me as Sir/sirs


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TimG

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Posted 01 September 2021 - 01:26 PM

I'm not sure why you would need description, storage conditions, and shelf life on a manufacturing record.  Do all of your production workers have 2-4 year degrees? I have never ever ever ever worked in an environment where an average production worker would be your target audience for 'Theoretical yield vs. actual yield at each step (acceptable limits as well)'.

 

Edit: My post came off harsh when I re-read it, sorry about that. What is your end goal with this document and what standards are you under?


Edited by TimG, 01 September 2021 - 01:27 PM.


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detario

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Posted 02 September 2021 - 01:22 PM

Not harsh at all, thank you both for the feedback.  The two people responsible for filling this out in general have a minimum of four years of college; as the company grows though that may change so I will simplify things.  We make a few different things, but the department I am assisting largely makes dietary supplements, hence the extra information regarding description, storage conditions and shelf life.  We are trying to pass the NSF standard actually, and I'm not looking for anything too lofty as far as goals are concerned; I just need to get receive certification.



billbrochin

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Posted 02 September 2021 - 03:09 PM

link to FDA CFR 21 111, subpart H for MMR information.

Electronic Code of Federal Regulations (eCFR)



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Scampi

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Posted 02 September 2021 - 05:22 PM

Ah---so you're wanting help with the master record? The code reads to me like that's for your file

ops will have a (see below)

Batch Production Record §111.260   What must the batch record include?

The batch production record must include the following:

(a) The batch, lot, or control number:

(1) Of the finished batch of dietary supplement; and

(2) That you assign in accordance with §111.415(f) for the following:

 

etc. etc. etc


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detario

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Posted 02 September 2021 - 08:02 PM



detario

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Posted 03 September 2021 - 07:49 PM

Fairly stupid question: as far as having these records and other logs in a clean area, what do you find to be the best method?  At my last job we kept everything in binders and at the job I held prior, we printed everything on low particulate clean room paper.



TimG

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Posted 13 September 2021 - 05:36 PM

Have you considered storing them onsite but in the office or maybe in the QC area? Perhaps the record itself (daily or weekly) is only kept in that 'clean' area until it is completely filled out and then is 'turned in' to the appropriate department or person for final review/filing. This would mitigate any increased risk from a binder being in a clean area.

Or you could always move towards digital recordkeeping, but that's easier said than done.



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detario

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Posted 17 September 2021 - 03:31 PM

I would love to move towards digital recordkeeping, but with the size of the company and availability of resources that won't be happening anytime soon.  I'm setting it up like we did at a dairy company I worked at with our temperature logs.  Single piece of paper on a metal (not wood obviously) clipboard and then to QA for document retention after completion.  It seems like the simplest and most cost effective method.  






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