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.

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 ?

Try the Federal trade comission Part 500

Try the Federal trade comission Part 500

Is it http://www.ftc.gov/os/statutes/fpla/part500.shtm ?

Yes it is

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.

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.

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.

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.