Sop for Rounding of analytical results

It describes the (Standard Operating procedure)  SOP for Rounding of analytical results in Quality Control Laboratory .

Sop for Rounding of analytical results

I. Purpose & Scope:

• To provide a general methodology to be followed for Rounding of analytical results in Quality control laboratory of pharmaceutical industry
• Applicable to all personnel who are working in Quality control laboratory.

II. Responsibilities:

• All Quality Control and related personnel shall be responsible to follow and implement this SOP.

III : Introduction and Procedural Part :

PROCEDURE:

• Ensure the correctness of all entries in analytical data.
• Ensure whether all the results are complies with the specification.
• If the criterion meets the specification, then the observed values shall be rounded off to the number of decimal places that is in agreement with the limit expression.
• Numbers should not be rounded until the final calculations for the reportable value have been completed.
• Intermediate calculations (e.g. Slope for linearity) may be rounded for reporting purposes but the original value should be used for any additionally required calculation.
• Acceptance criteria are fixed numbers and shall not be rounded off.
• While rounding the figure, refer table no.1, 2 & 3 (Annexure-I) for decimal places to be expressed for final recording.
• If the last digit is smaller than 5 it is eliminated and the preceding digit is Unchanged.
• If this digit is equal to or greater than 5, it is eliminated and the preceding digit is increased by 1.
• Consider the digit next to the intended digit for particular expression.

                                               Table No. : 01 

• For Assay and Uniformity of Content use 1 digit after decimal point. Refer Table No.01.
• Dissolution values shall reported complete round off. No decimal shall be used. Refer Table No. 01.
• For Water content, LOD & Related substances use 2 digits after decimal place. E.g. Impurity is 0.145% considers 5 as rounding & value will be 0.15%.
• For uniformity of weight report the values in 2 digits after decimal point.
• If the specification limit for water content, LOD is ≥0 % then report the values in 2 digits after decimal point.
• If the specification limit for water content, LOD is above the 1.0% then report the values in single digit after decimal point.
• If the specification limit for impurities is in 2 digits after decimals point e.g. not more than 0.10% then reports the values in 2 digits after decimals point.
• If the specification limit for impurities is in 1 digit after decimal point e.g. not more than 0.5 % then reports the values in 2 digits after decimal point and if above 1.0 % then reports the values in 1 digit after decimal point.
• Refer to Annexure – I, which illustrate rounding numerical values for comparison.
• For rounding the test results of assay and uniformity of content refer table no.1.0, for Dissolution refer table no.2.0 and for LOD, Related substances refer table no.3.0.
• Recording shall be performed only once preferably in results.The rounded values shall be report on COA.

Annexure :

Annexure -I : ILLUSTRATION OF ROUNDING NUMERICAL VALUES FOR COMPARISON WITH REQUIREMENTS.

Annexure -I

ILLUSTRATION OF ROUNDING NUMERICAL VALUES FOR COMPARISON WITH REQUIREMENTS.

TABLE No. 1.0: Assay & Uniformity of Content

TABLE No 2.0: Dissolution

TABLE No.: 3.0: Related substances