SOP Title: Rounding and Reporting of Test Results

SOP Title: Rounding and Reporting of Test Results

 

1. Objective:

To lay down the procedure for Rounding and Reporting of Test Results in the Quality Control Department.

2. Scope:

This procedure is applicable for Rounding and Reporting of Test Results in the Quality Control Department.

 

3. Responsibility:

• Quality Control Department: To prepare and review the SOP. To follow the procedures laid down for Reporting of Test Result in Quality Control Department as per this SOP.
• Quality Assurance Department: To review and approve the SOP and Annexure.

 

4. Accountability:

Head Quality  Control Department, Head Quality  Assurance Department.

5. Procedure:

5.1	Significant figure determination :
5.1.1	Number of digit in a decimal or whole number, to be considered as significant or representative of the real value, specification limit or a result of a particular method, operation or process is called as significant figure.
5.1.2	In case there is no decimal place mentioned in specification, no decimal place should be reported.
5.1.3	In case the signification limit is expressed in decimal place the result obtained shall also be documented in decimal place, following the same number of decimal place.
5.1.4	The analytical result which is above 1.0 percent, the result shall be reported up to specification limit.
5.1.5	The analytical result which is equal to or below 1.0 percent, the result shall be reported up to two digit after decimal place.
5.1.6	The balance/equipment used for the process, must provide accuracy up to the last digit established by the current specification.
5.2	Rounding :
5.2.1	Abbreviate to one digit beyond the significant digit required.
5.2.2	Illustration of Rounding Numerical Values for Comparison with Requirements Compendial Requirement Unrounded Value Rounded Result Conforms Assay limit ≥ 98.0% 97.96% 98.0% yes 97.92% 97.9% No 97.95% 98.0% yes Assay limit ≤ 101.5% 101.55% 101.6% No 101.46% 101.5% yes 101.45% 101.5% yes Limit test ≤ 0.02% 0.025% 0.03% No 0.015% 0.02% yes 0.027% 0.03% No Limit test ≤ 3ppm 3.5 ppm 4 ppm No 3.4 ppm 3 ppm yes 2.5 ppm 3 ppm yes
5.3.3	( Example :- If that digit is 0,1,2,3,4 than the previous digit remain same and if that digit is 5,6,7,8,9 than the previous digit increase by one.). Specification Limit NMT 1.0 Specification Limit NMT 1.00 Calculated Result Rounded value     Calculated Result Rounded value 0.90 0.9 0.950 0.95 0.91 0.9 0.951 0.95 0.92 0.9 0.952 0.95 0.93 0.9 0.953 0.95 0.94 0.9 0.954 0.95 0.95 1.0 0.955 0.96 0.96 1.0 0.956 0.96 0.97 1.0 0.957 0.96 0.98 1.0 0.958 0.96 0.99 1.0 0.959 0.96
	Exceptions :
5.2.4	In case of reporting where the result becomes “zero” after rounded value, the result shall   be reported up to least calculated numeric value.
5.2.5	To calculate the Assay on anhydrous basis, moisture content/LOD shall be taken in to report calculated value as per specification. Specification Limit NMT 1.0 Calculated Result Rounded value 0.1446 0.1 0.1486 0.1 0.0652 0.1 0.0446 0.04 0.0057 0.01 0.0041 0.004 0.0026 0.003 0.0006 0.001 0.0002 0.0002     Parameter Specification limit Calculated result Reported value Value for assay calculation Loss on drying 1.0 0.3456 0.35 0.35 Water content 1.0 0.7327 0.73 0.73
5.2.6	In case specification limits containing two specification limits, first result  shall be reported more than one decimal of specification limit, the second result shall be considered as final result and will be reported after rounding off up to same decimal of specification limit. Parameter Specification limit Calculated result Reported value Assay 4.75 mg to 5.25 mg 5.0428 5.043 95.0 % to 105.0 % 100.856 100.9
5.2.7	In case reported result is close to specification limit and after rounded value the results is same as specification limit, the result shall be reported more than one decimal of specification limit. e.g. In case, the specification limit is 15.0 and the observed result without rounded value is within 14.95 to 15.04 than the result shall be reported more than one decimal of specification limit.

 

6. Definitions / Abbreviations :

• Definitions :
• Interpretation: Analytical results observed in the laboratory (or calculated from experimental measurements) are compared with stated acceptance criteria to determine whether the article conforms to compendia requirements.

The reported value, which often is a summary value for several             individual determinations, is compared with the acceptance criteria.      The reportable value is the end result of a completed                      measurement procedure, as documented.

Where acceptance criteria are expressed numerically herein through specification of an upper and / or lower limit, but no value outside the limit(s). Acceptance criteria are considered significant to the last digit shown.

• Rounding Rules: The observed or calculated values shall be rounded off to the number of decimal places that is in agreement with the limit expressions for the reportable value have been completed. Intermediate calculations (e.g. slope for linearity) may be rounded for reporting purpose, but the original (not rounded) value shall be used for any additional required calculations. Acceptance criteria are fixed numbers and are not rounded.

 

• Abbreviations:

Abbreviation	Expansion
QC	Quality Control
QA	Quality Assurance
e.g.	Example
No.	Number
NMT	Not more than
LOD	Loss on drying
%	Percent
USP	United State of Pharmacopoeia

*Note – Ready to use SOP available in “DOWNLOAD” Section.