SOP on Calculation of Yields

1.0 Purpose: This SOP describes the guidelines for calculating yields at various stages

during manufacture of a batch of drug product.

2.0 Scope: This SOP applies to Production staff.

3.0 Responsibility: Production Chemist to ensure that procedure is followed.

4.0 Materials and Equipment: As required.

5.0 Procedure: 

5.1 Actual yields and percentages of theoretical yield shall be determined at the

conclusion of each appropriate phase of manufacturing, processing, packing, or holding

of drug product. Such calculations shall be performed by one person and independently

verified by a second person.

5.2 Theoretical yield is the maximum quantity that could be produced, based on

quantities of components used, in absence of any loss or error in the production.

5.3 Theoretical yield consists of the summation of weights of all raw materials entering

production cycle. For granulations, powders, and tablet coatings, an amount equal to

evaporated solvent should be subtracted.

5.4 Based on historical data an acceptable range for actual yield at each appropriate stage

can be calculated.

5.5 The range is set so that 95% of batches produces will fall within the range when

process is operating correctly.

5.6 Purpose of this is to alert management to atypical situations that may require

investigation.

5.7 Low yields may not only signal potential problems but may also indicate

opportunities for process improvement with subsequent cost benefits.

5.8 Process loss can occur for a variety of reasons including dust extractions, spillage of

components or product, machine losses such as in compression, machine adjustments,

samples, or residue on equipment.

5.9 A second person verifies independently yield calculations.