Procedure For Rounding off procedure for analytical numeric values
1.0 Objective
The purpose of this SOP is to provide written procedures for rounding off procedure for analytical numeric values.
2.0 Scope
Standard Operating Procedure is to provide guidelines for rounding off procedure for analytical numeric values at abc company.
3.0 Responsibility
3.1 Executive – Quality Control.
3.2 In charge/Head-Quality Control.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
QC : Quality Control
CC NO : Change Control Number
cGMP : Current Good Manufacturing Practice
G : General
5.0 Procedure
5.1 In case of Raw materials report the results up to 2 decimal place by rounding
off 2nd digit as follows, If 3rd digit is 5 or more than 5, round the digit to its next
digit & if 3rd digit is less than 5, 2nd digit remains same. Example: If Assay is 99.365 %
Report as 99.37%, If Assay is 99.342% Report as 99.34%.
5.2 In case of finished product report the results up to 3 decimal place by rounding off 3rd
digit as follows, If 4th digit is 5 or more than 5, round the digit to its next digit & if 4th
digit is less than 5, 3rd digit remains same. Example : If assay is 0.9175%
Report as 0.918%. If assay is 0.9172% Report as 0.917%.
5.3 In case of Normality / Molarity of volumetric solution report the results up to
4 decimal place by rounding off 4th digit as follows, If 5th digit is 5 or more than
5, round the digit to its next digit & if 5th digit is less than 5, 4th digit remains same.
Example: If Normality/ Molarity of solution is 0.10565M than
report as 0.1057 M, If it is 0.10532M than report as 0.1053M.
5.4 In case of calibration report the results up to 3 decimal place by rounding off
3rd digit as follows, If 4th digit is 5 or more than 5, round the digit to its next digit & if
4th digit is less than 5, 3rd digit remains same. Example: In case calibration RSD % is 2.0025%
Report as 2.003%, If RSD is 2.0022% than report as 2.002.
6.0 Forms and Records
6.1 None.
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Control copy – Quality Assurance, Quality Control
8.0 History
| Revision Number | Details For Change |
Reason for Revision |
| 00 | New SOP | NA |
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Procedure For Rounding off procedure for analytical numeric values