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View Full Version : Date of Manufacture takes place over a period of multiple days


chiragtilara
8th June 2005, 05:05 PM
Our production/manufacturing for a single product takes place over a period of multiple days. We are confused as to what date should we use as a date of manufacture.

We operate in two shifts, so operators in night/evening shift may start the batch but is completed on next day. Most of the batches have sub-batches that are made in auxilliary reactors and then all the sub-batches are combined in main reactors.

Please advise. Thanks in advance.

RCW
8th June 2005, 05:14 PM
My facility also manufactures some its products over the course of days and sometimes weeks. We use the day the materials are pulled from stock as our DOM. It is considered the starting point of the actual build or "birth" of the product.

Rachel
8th June 2005, 05:20 PM
As long as you're consistent with your method, I don't see why it matters how you do it. If you're going to take it as the date that you pull the raw materials from stock, then fine. If you're going to take it as the date that it's packaged, fine. As long as you're consistent with it, I wouldn't see why it matters...having a date should be able to lead you to the production records, and then you're good. (Mind you, I think it would make more sense to take the start date of the run, from a record-keeping perspective.)

I suppose it depends on what industry you're talking about as well, though. If we're talking about food, beverages, or something like that, then you may be subject to more specific rules.

chiragtilara
9th June 2005, 09:23 AM
Guys,

Thanks for your input and you are right as this was my initial response to my colleagues.

1. Yes we are regulated by FDA and that is the reasons I wanted to know if there was a specific industry standard that we should follow.
2. We are contract mfgrs/packers so we get clients that want different systems to follow. If there was a industry standard we can follow them and present to our clients that it is the standard that we are following.

-CMT