How can I calculate the overage of an excipient in the manufacturing process?
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Dear Saras,
Could you write subject more clearly. Maybe I can help.
Regards
Ilknur
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How it is calculated the Overage (Excess) in the manufacturing product?
Ex: I have an overage of an excipient in my manufacturing process, but I dont know how to calculate its overage (excess)
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If required qty of material is 250 mg/single dose and as per BOM if you take 252.5 mg/single dose means you have taken 1% overages of the material.
Do I have to take overage for every ingredients (API + excipients)?
Dear Saifullah,
Overages are already defined in either Master formula or BMR (BOM) page , as per the initial pilot and exhibit batches.
If you are executing regular batch in production, no need to calculate.
But, Is overage mandatory? when should is it apply?
Overages are nothing but the extra quantity of material taken, which is lost during process stage.
in order to deliver the product with exact quantity(within limit) of API & excipient or Coating material
This is being calculated and studied while executing exhibit batches, and it is defined in Master formula .
While preparing master BMR these things are calculated and standard qty is mentioned.
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Concept of overages are usually taken for the dietery supplements like for vitamins which degrades very frequently in formulation hence to compensate that degradation, overages concept is used. Overages are not used for the potential drugs. Calculation formula is already explained above.
it is also for human use drugs in Pharmaceutical.
Yes it is but unless justified. Just for the sole purpose of Extending shelf life is not acceptable.
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@deep_8303 Sir, when it is justifiable? When I am taking overage do I have to take 1% or is it variable?
@saifulnsu
Overages are justified wherever To compensate or restore the loss during formulation production or processing and are referred as processing overages. Eg. Sticking of drug to the walls of a vessel, during usage - in case of aerosol container. 2. Overages are added to the formulation which undergo time related loss of active ingredient and are referred as Life time overages. Overages added may or may not appear in the final formulation Factors to be considered 1. Stability of the drug 2. Type of product 3. Shelf life expectancy of product.
I am.not aware of any guidance binds for the % of overages but I believe it depends upon the factors stated above but not limited to.
WHO guidances says a bit about it. You can refer that.
thank u sir
Maam pls tell me about how to take vitamins overages