2.0 SCOPE
2.1 This SOP shall be applicable to rounding off figures in the Department of Quality assurance (QAD).
3.0 RESPONSIBILITY
3.1 Head-QA
3.2 All personnel involved in writing any documents
4.0 DEFINITIONS
4.1 Nil
5.0 PROCEDURE
5.1 Rounding of numbers shall be done in the following cases:
5.1.1 While reporting results, express it up to one digit more after the decimal point than that it expressed in limit.
5.1.2 Only one digit in the decimal place to the right of the last place in the limit expression shall be taken into account.
5.1.3 If the digit under consideration is less than 5, it is eliminated and the preceding digit remains unchanged. e.g. 100.434 --> 100.43
5.1.4 If the digit under consideration is greater than or equal to 5, it is eliminated and the preceding digit is increased by 1 e.g. 100.468 --> 100.47
5.1.5 During calculation, the exact values shall be used. The final calculated value shall be rounded off.
5.1.6 Data generated from the instruments should be recorded directly in data recording sheets (DRS) and all entries should be made in excel/software to be used for calculations. No rounding off should be done while entering data from DRS to excel / software and only final results should be rounded off after calculations.
5.1.7 Some instrument outputs contain an excessive number of digits. In these cases, data entry in DRS should be at least 5 digits (if available) to prevent error due to successive rounding.
5.1.8 In the certificate of analysis only the rounded-off figures should be mentioned.
5.1.9 The calibration range must be reported using the same rounding and significant figure rules as the associated sample data.
5.1.10 All results values should be reported based on the limit expression. An illustration for the same has been given in Table-I.
Table – 1 Illustration of rounding numerical values for comparison with requirements
|
Compendial requirement |
Unrounded value |
Rounded value |
Conforms |
|
Assay limit greater or
equal to 98.0% |
97.96% |
98.0% |
Yes |
|
97.92% |
97.9% |
No |
|
|
97.95% |
98.0% |
Yes |
|
|
Assay limit less or
equal to 101.5% |
101.55% |
101.6% |
No |
|
101.46% |
101.5% |
Yes |
|
|
101.45% |
101.5% |
Yes |
|
|
Limit Test less or equal
to 0.02% |
0.025% |
0.03% |
No |
|
0.015% |
0.02% |
Yes |
|
|
0.027% |
0.03% |
No |
|
|
Limit Test less or equal
to 3 ppm |
3.5 ppm |
4 ppm |
No |
|
3.4 ppm |
3 ppm |
Yes |
|
|
2.5 ppm |
3 ppm |
yes |
5.2 Rounding of numbers shall not be done in the following cases.
5.2.1 The pH values shall be recorded as displayed on the pH meter.
5.2.2 Limits, which are fixed numbers, shall not be rounded off.
5.2.3 While calibrating the weighing balance with standard weights, the weight displayed to the last decimal by the balance shall be recorded without rounding off.
6.0 ENCLOSURES
6.1 Nil
7.0 ABBREVIATIONS
7.1 SOP- Standard Operating Procedure
7.2 QAD- Department of Quality Assurance
8.1 In-house
9.0 REVISION HISTORY
9.1 Nil
END OF DOCUMENT
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