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Rounding off Values In GMP Documents in Pharmaceuticals


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 gm, 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 gm, the quantity is expressed upto the third decimal place.  Percentage yield is expressed upto the second decimal place.
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


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