Rounding Off Values in GMP

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    Rounding Off Values In GMP DocumentsAssay CalculationWhile doing any assay calculation the result of assay is expressed upto one decimal place more than

    the significant figures stated and then the results are rounded up or down as follows.If the last figure calculated is 5 to 9, the preceding figure is increased by 1 & if it is 4 or less, the

    preceding figure is left unchanged.To find out significant figures for particular value refer its specification limit, e.g. if limit is 99.00 to

    102.00 then two decimals from decimal point are significant. If limit is 98 to 101 then significant

    figures are without decimal point.Microbial Limit Test Report : The reading of count expressed as a whole number. Pathogens reading

    is reported as Present / Absent / Positive / Negative.Water analysis / Slit Air Sampling / Bacterial Count / fungal Count / Settle Plate / Swab : Is expressed

    as a whole number.Microbial Assay : Any microbial assay is expressed either in terms of percentage / microgram /

    milligram.Loss On DryingResult of loss on drying is expressed in terms of percentage upto second decimal place and the

    results are rounded up or down as mentioned in assay calculation.Sulphated AshResult of sulphated ash is expressed in terms of percentage upto fourth decimal place and the results

    are rounded up or down as mentioned in assay calculation.Loss On IgnitionResult of loss on ignition is expressed in terms of percentage upto second decimal place and the

    results are rounded up or down as mentioned in assay calculation.HPLC CalculationArea of standard & sample in Agilent series HPLC system is expressed up to the third decimal place,

    e.g. 237.293, 2.293 etc.NOTE : Area of standard & sample in Thermo Separation series HPLC system is not expressed in

    decimal place.ImpurityAny Impurity is expressed up to the third decimal place, e.g. 0.101, 0.500 etc.Absorbance measured on the SpectrophotometerAbsorbance is expressed up to the third decimal place, e.g. 0.101, 0.500 etc.Gas ChromatographyArea of standard & sample is expressed up to the fourth decimal place.Temperature & Humidity of Stability OvensTemperature & humidity of stability ovens is expressed upto one decimal place.Temperature & Humidity of Control Sample RoomTemperature & humidity of control sample room is expressed as the actual temperature displayed on

    the Thermometer, e.g. 22C, 25C, etc.Bin CardsBin Cards of Raw Material :When material is received / issued in terms of kg, the quantity is expressed upto the third decimal

    place & when material is received / issued in terms of g., the quantity is expressed upto the third

    decimal place.Bin Cards of Packing Material :

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    When printed packaging material like labels, cartons, leaflets, BOPP Tape, Corrugated boxes are

    issued, it is expressed in terms of numbers.When unprinted packaging material like containers, bottles are issued, it is expressed in terms of

    numbers.

    Printed / unprinted foil when issued is expressed in terms of kg.

    Batch Manufacturing DocumentsWhen material is weighed in terms of kg, the quantity is expressed upto the second decimal place &

    when material is weighed in terms of g., the quantity is expressed upto the third decimal place.

    Percentage yield is expressed upto the second decimal place.