21 CFR 211.103 Calculation of Yield

[emorin]

Could someone please share an example of how they integrated the following regulation into their quality system:

21 CFR Part 211.103 Calculation of yield...

"Actual yields and percentages of theoretical yield shall be determined at the conclusion of each appropriate phase of manufacturing, processing, packaging, or holding of the drug product. Such calculations shall either be performed by one person and independently verified by a second person, or, if the yield is calculated by automated equipment under §211.68, be independently verified by one person."

I am having trouble understanding this in the context of the product our organization makes which is a drug substance that gets sent to another manufacturer.

Thank you in advance!

 

[Ajit Basrur]

Before you go into these 21 CFR 211.103 requirements, you have to take a look at the definitions of Theoretical Yield, Actual Yield and Percentage Yield given in 21 CFR Part 210.3.

At the conclusion of each appropriate phase of manufacturing, processing, packaging, or holding of the drug product, the Actual Yield is calculated and then a percentage of actual yield divided by theoretical yield is calculated.

This percentage yield is an important attribute as it gives info regarding process control. Lower yields indicate process problems and needs investigation.

The second sentence on verification by a second person is to ensure that the calculations are correct.

 

[emorin]

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Hi Ajit, Thank you for the reply. Is there a specific example you could provide please to help me understand the context?

 

[emorin]

Also, I am not sure why this post got title "Automated equipment question", I don't remember putting that. I understand the automated equipment part of the regulation. What I don't understand is in what situations to calculate the yield of a substance/product. Thanks!

 

[Ajit Basrur]

Deleted "Automated equipment question". Btw, this was part of your earlier question.

 

[Marc]

Also, I am not sure why this post got title "Automated equipment question", I don't remember putting that. I understand the automated equipment part of the regulation. What I don't understand is in what situations to calculate the yield of a substance/product. Thanks!

I often re-title threads based upon the first post content for various reasons. Sometimes I mis-title a thread. My apologies. In this case I goofed.