1.0 Purpose
1.1 To lay down the procedure for rounding off the analytical results.
2.0
Scope
2.1 This procedure is applicable to round off the calculated results of the test parameters of RM, PM and FP analysis in Quality control of "NAME" Pharmaceuticals Ltd.
3.1
Officer
to Sr. Officer/designated person of Quality Control is responsible to follow
the SOP.
3.2
Head
of Quality Control is responsible for the implementation of this SOP.
3.3
Head
of Quality Assurance is responsible for compliance of the SOP.
4.0 Abbreviations and Definitions
4.1 SOP : Standard Operating Procedure
4.2 Round off Analytical Result: The results of analysis are expressed by two quantities. First is the numerical quantity and the other is a unit of measurement. The results of most analysis are calculated manually or displayed by the system in digital format. More often the results are displayed in integers and decimals. Beyond a certain number of decimal points the numbers lose their significance so it becomes necessary to round off the results so as to make the results more meaningful and understandable.
5.0 Materials and Equipment
5.1 None
6.0 Precaution / Health and Safety Considerations
6.1 During calculation analyst should carefully rounding off the analytical results so that no Confusion arises.
7.0 Procedure
7.1 General rounding off conventions:
7.1.1 The observed or calculated values shall round off to the number of decimal places that is in agreement with the specification.
7.1.2 Numbers should round until the final calculations for the reportable value have been completed.
7.1.3 Results of loss on drying, loss on ignition, Water content, pH, and conductivity should express in 2 decimal places.
7.1.4 Results of impurity are rounded off to 3 decimal places.
7.1.5 In case of assay and content uniformity, expressed in mg/µg/g/IU/% in w/w, w/v, v/v, then follow the following procedure:
i) If claim is less than 1 then result express up to three decimal.
ii) If claim is less than 10 then result express up to two decimal.
iii) If claim is more than 10, then result express up to one decimal.
7.1.6 In case of dissolution, result express as full numerical number(No decimal use)
7.2 When rounding is required, consider only one digit in the decimal place to the right of the last place in the limit expression
7.2.1 When the digit succeeding the number to be retained is less than 5, it is eliminated and the retained digit remains unchanged.
Example: The result is 99.992% is to be rounded off to 2 decimal places. As 2 in the third decimal places is less than rounding to 2 decimal places on rounding off it becomes 99.99%.
7.2.2 When the digit succeeding the number to be retained is more than 5, it is eliminated and the retained digit is increased by 1.
Example:
1) The result is 1.437 and is to be rounded off to 2 decimal places. As 7 is more than 5 the result is expressed as 1.44
2)The result of is 99.998% and needs to be rounded off 2 decimal places. As 8 in the third decimal place is more than 5 the result on rounding off to 2 decimal places will become 100.00%.
7.3 Example of various parameters for rounding off the value:
Sl No. |
Specification
or requirement |
Un-rounded value |
Rounded Value |
Conforms |
1 |
Assay limit ≥98.0% |
97.96% |
98.0% |
Yes |
97.92% |
97.9% |
No |
||
97.95% |
98.0% |
Yes |
||
2 |
Assay limit ≤101.5% |
101.55% |
101.6% |
No |
101.46% |
101.5% |
Yes |
||
101.45% |
101.5% |
Yes |
||
3 |
Limit Test ≤0.02% |
0.025% |
0.03% |
No |
0.015% |
0.02% |
Yes |
||
0.027% |
0.03% |
No |
||
4 |
Limit test ≤3ppm |
3.5 ppm |
4 ppm |
No |
3.4 ppm |
3 ppm |
Yes |
||
2.5 ppm |
3 ppm |
Yes |
||
5 |
Dissolution limit ≥80% |
79.5% |
80% |
Yes |
79.4% |
79% |
No |
||
80.4% |
80% |
Yes |
8.0 Reference Document
8.1 In-house
9.0 Annexure
9.1 None
10.0
Revision
History
Revision No. |
Brief
reason for the revision |
Effective Date |
Remarks |
01 |
New |
|
|
11.0 Training
11.1 Head of Quality Control or his/her nominee shall give the SOP training before effective date.