Batch Yield Calculation in Pharmaceutical Production


Production yield is a value in % that results from dividing the number of good units (output) by the total number of units (input).


Production Yield Calculation Formula

Yield Percentage (%) = (No. of actual unit ÷ No. of theoretical unit) X 100

or

Yield Percentage (%) = (Actual quantity of goods produced/Theoretical quantity of goods expected) X 100


Batch Yield Calculation Formula

%Yield = (Actual Quantity of Good Products ÷ Theoretical Quantity of Batch size) X 100


For example,

If a product batch size is 100,000 pcs and number of good product is 95,000 pcs, the % yield will be –

%Yield = (95,000 ÷ 100,000) × 100 = 95%


In pharmaceutical industry, the yield percentage (%) is determined at the conclusion of each appropriate phase of manufacturing, processing, packaging, or holding of the drug product.


For yield calculation at compression stage,

Yield as percentage (%) = (A ÷ B) X 100 %

Here,

B = Weight of granules for compression

A = Weight of accepted tablets


For example,

If the weight of granules for compression is 550 kg and weight of accepted tablets is 540 kg; thus actual yield will be –

(540 ÷ 550) X 100 % = 98.18 %


Production Yield Calculation in Excel


As per 21 CFR 211.103,

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.


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1 Comments

  1. Please share also batch reconciliation process in pharmaceutical industry.

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