Rounding off Values In GMP Documents in

Pharmaceuticals
Categories: GMP , quality control
Sep 1, 2011

Learn how to Round Off the Figures in Pharmaceuticals as per GMP.

Assay Calculation
While 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 Drying
Result 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 Ash
Result 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 Ignition
Result 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 Calculation
Area 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.

Impurity
Any Impurity is expressed up to the third decimal place, e.g. 0.101, 0.500 etc.

Absorbance measured on the Spectrophotometer

Absorbance is expressed up to the third decimal place, e.g. 0.101, 0.500 etc.

Gas Chromatography
Area of standard & sample is expressed up to the fourth decimal place.

Temperature & Humidity of Stability Ovens

Temperature & humidity of stability ovens is expressed upto one decimal place.

Temperature & Humidity of Control Sample Room

Temperature & humidity of control sample room is expressed as the actual temperature
displayed on the Thermometer, e.g. 22°C, 25°C, etc.

Bin Cards
Bin 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 :
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 Documents
When 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.