FDA - "Net Quantity of Contents" - Manufacturing Filling Process

M

MfgPro

I'm trying to determine where to set the nominal weights and volumes for a manufacturing filling process for an OTC pharmaceutical product in order to meet the "requirements" for product weight.

When I look at 21 CFR 801, the only thing I see is the need an "accurate" statement of the quantity of contents of the package and that "unavoidable deviations" in good manufacturing practice will be recognized.

From this, it seems as though the nominal can be set right on the label weight. Is that correct?

I've also heard elsewhere that the process needs to be set so that the weight NEVER drops below the label weight.

I've looked online and I haven't been able to find any good sources for guidance on this. Can anyone please shed some light on what the requirements actually are for the U.S. and EU?

Thanks.
 
Last edited by a moderator:
Ajit Basrur

Ajit Basrur

Leader
Admin
Re: FDA - "Net Quantity of Contents"

Hi Glenn601,

I have moved your question to this section on FDA to get more responses.

Btw, could you pl clarify your question and also state what is the product that you are referring to ?
 
J

jscotto

Re: FDA - "Net Quantity of Contents"

Try the Federal trade comission Part 500
 
M

MfgPro

OK. In looking at this, in 500.25 (a), it says, "The statement of net quantity of contents shall accurately reveal the quantity of the commodity ..." which to me seems to leave a lot to interpretation.

Going back to my original question, is it OK to set my nominal process weight to be on the label weight, or does it need to be set so that it doesn't dip below the label weight?

Unless I'm missing something, the use of the "accurately" statement doesn't say anything or take into account the process capability or normal deviation of the filling process.
 
J

jscotto

My experience is with solid doses. Our SOP indicates that we are not to go below the count that is indicated on the bottle. People tend to count the tablets in a bottle. If you are doing the contents by weight, the variance is only as good as the weighing equipment being used.
 
M

MIREGMGR

Glenn601 said:
OK. In looking at this, in 500.25 (a), it says, "The statement of net quantity of contents shall accurately reveal the quantity of the commodity ..." which to me seems to leave a lot to interpretation.

Going back to my original question, is it OK to set my nominal process weight to be on the label weight, or does it need to be set so that it doesn't dip below the label weight?

Unless I'm missing something, the use of the "accurately" statement doesn't say anything or take into account the process capability or normal deviation of the filling process.
Click to expand...

21 CFR 801.62(q) says, in full: "
(q) The declaration of net quantity of contents shall express an accurate statement of the quantity of contents of the package. Reasonable variations caused by loss or gain of moisture during the course of good distribution practice or by unavoidable deviations in good manufacturing practice will be recognized. Variations from stated quantity of contents shall not be unreasonably large."

It seems clear to me that the nominal fill and the stated content quantity should be equal. The key to that interpretation is recognition that the FDA's use of "unreasonably" is a lawyerly "term of art" that avoids the need for a massive technical discussion of all possible process-capability-and-deviation factors, and substitutes the reasonable judgment of an independent evaluator, i.e. the FDA inspector.

I'd think that having the average fill be validation-proven equal to the stated content quantity, with documentation that your process has an industry-normal degree of precision and consistency for the task at hand, would be clear compliance.
 
D

debbiees

I have a question about the allowed variation tolerated from the net package declaration for cookies. The cookies are not perfectly uniform in weight and size so there is a small variation in the package weight. We have multiple packs per selling container so there is also a variation, slightly below or above the total net weight declared on the retail package.

I've read the FDA regulations, specifically 16 C.F.R. part 500, and I do not find a specific tolerance just a general guideline.

Can we be slightly below the stated new weight in some of our packages or is it better to always be at or above the stated net weight for all our packages.

In Canada a slightly lower weight is tolerated and there are very specific guidelines that are not "open to interpretation".

Thanks
 
Jim Wynne

Jim Wynne

Leader
Admin
debbiees said:
I have a question about the allowed variation tolerated from the net package declaration for cookies. The cookies are not perfectly uniform in weight and size so there is a small variation in the package weight. We have multiple packs per selling container so there is also a variation, slightly below or above the total net weight declared on the retail package.

I've read the FDA regulations, specifically 16 C.F.R. part 500, and I do not find a specific tolerance just a general guideline.

Can we be slightly below the stated new weight in some of our packages or is it better to always be at or above the stated net weight for all our packages.

In Canada a slightly lower weight is tolerated and there are very specific guidelines that are not "open to interpretation".

Thanks
Click to expand...

16 CFR Part 500 is a U.S. Federal Trade Commission thing, not FDA. The relevant part (25a) says:

Variations from the stated weight or mass, measure, or numerical count shall be permitted when caused by unavoidable deviations in weighing, measuring, or counting the contents of individual packages which occur in good packaging practice: Provided, that such variations shall not be permitted to such extent that the average of the quantities in the packages comprising a shipment or other delivery of the commodity is below the quantity stated, and no unreasonable shortage in any package will be permitted even though overages in other packages in the same shipment or delivery compensate for such shortage. Variations from stated quantity of contents shall not be unreasonably large.

So, the average package net weight of a shipped lot can't be less than the stated net weight on the package label, and there can be no "unreasonable" variation in any given individual package. Perhaps someone here with experience in food packaging can give an idea of what "unreasonable" might mean in practice.
 
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