PROCEDURE FOR ROUNDING OFF NUMERICAL VALUES AND REPORTING SYSTEM
PURPOSE OF SOP ON REPORTING: To describe the procedure for rounding off numerical values and reporting system.
SCOPE OF SOP ON REPORTING: This Standard Operating Procedure (SOP) shall be applicable for rounding off numerical values and reporting systems in Quality Control, Production, IPQA and Warehouse Departments.
REFERENCESOF SOP ON REPORTING:
In-house/USP/IP
CROSS-REFERENCE DOCUMENTS
Training Programme and Management
Document(s) and Data Control Procedure
ATTACHMENTS
Attachment/Annexure/Formats
| S.No | Attachment Title | Format No. |
| 1 | Attachment-I | Illustration of rounding off numerical values and reporting system |
DEFINITION
Rounding off: means a number is made simpler by keeping its value intact but closer to the next number. It is done for whole numbers and for decimals at various places of hundreds, tens, tenths, etc.
RESPONSIBILITY OF SOP ON REPORTING:
- Executive / His designee of concerned departments:
- Shall be responsible for rounding off and averaging of numerical values.
2. Concerned Department Head
- Shall be responsible for follow-up of this SOP.
- Shall be responsible for the implementation of this SOP.
3. Plant Head:
- To ensure implementation of the defined system.
OTHER RESOURCES: INJECTION
PROCEDURE:
- In the case of BMR and BPR, the rounding off of the digits after the decimal shall be done while entering the results.
- The % yield should be reported in two digits after the decimal point. While reporting the % yield, rounding off the second digit after the decimal should be done. If the third digit after the decimal is 5 or greater than 5, then the second digit should be rounded off to the next digit and if the third digit after the decimal is less than 5 then the second digit should be kept as it is, omitting the third digit. e.g.
- If the % yield comes to 99.258%, then this value should be reported as 99.26%. In this case, the third digit 8 after the decimal is greater than 5, hence second digit 5 is rounded off to the next digit 6, omitting third digit.
- If the % yield comes to 99.232%, then the value should be reported as 99.23%. In this case, the third digit 2 after the decimal point is less than 5, hence the second digit 3 is kept as it is, omitting the third digit.
- While calculating the actual quantity of the API required for the batch, the value shall be in three digits after the decimal point. If the fourth digit after the decimal is 5 or greater than 5, then third digit should be rounded off to the next digit and if the fourth digit after the decimal is less than 5 then the third digit shall be kept as it is, omitting the fourth digit, e.g.
- After calculation, if the quantity of the API is 154.2627 kg, then this value shall be entered as 154.263 kg.
- After calculation, if the quantity of the API is 154.2621 kg then this value shall be entered as 154.262 kg.
- During compression and coating, the readings for individual weight or weight of 20 tablets should be written by keeping three digits after the decimal point if the weight is in gram. If the weight is in milligram, the weight should be written in one digit after the decimal point. The third digit (if the unit is gram)/first digit (if the unit is milligram) after the decimal should be rounded off to its next digit, if the fourth digit (if the unit is gram)/second digit (if the unit is milligram) is 5 or greater than 5. The third digit (if the unit is gram)/first digit (if the unit is milligram) after the decimal should be kept as it is, if the fourth digit (if the unit is gram)/second digit (if the unit is milligram) is less than 5 and omit the fourth digit (if the unit is gram)/second digit (if the unit is milligram). e.g.
- If the individual weight of tablet is 0.6786 g then it should be reported as 679 g and if the weight is 0.6522 g then it should be reported as 0.652 g.
- If the individual weight of tablet is 678.67 mg then it shall be reported as 678.7 mg and if the weight is 652.22 mg then it shall be reported as 2 mg. During compression and coating, the thickness should be reported in two digits after the decimal point. If the third digit after the decimal is 5 or greater than 5, then second digit should be rounded off to the next digit and if the third digit after the decimal is less than 5 then the second digit should be kept as it is, omitting the third digit.
- Quality Control:
- Rounding off result shall be done only in final calculated result. When rounding off is required, consider only one digit in the decimal place to the right of the last place in the limit expression.
- If this digit is equal to or greater than 5, it is eliminated and the preceding digit is increased by one. If this digit is less than 5, it is eliminated and the preceding digit is same.
Assay calculation:
In Assay the result should be calculated to two decimal place more than the significant figure stated assay results in mg total digit should be five e.g. 00.000mg, 0.0000mg, 0000.0 mg and in percent00.0% or 99.5 then rounded according to point 6.3.2.
Microbial limit test report: The reading of count expressed as a whole number. Pathogens reported as Present / Absent / positive / Negative.
Loss on Drying / Water / Moisture: Result of loss on drying is expressed in terms of percentage up to second decimal e.g.00.00% place and the rounded up or down as per point 6.3.2.
Sulphated Ash or Residue on ignition: The result of Sulphated ash or Residue on ignition is expressed in terms of percentage up to two decimal place e.g. 0.00% and the rounded up or down mentioned in under point 6.3.2.
Loss on ignition: The result of loss on ignition is expressed in terms of percentage up to the second decimal place e.g. 0.00% and the rounded up or down mentioned
HPLC Calculation: The area of the standard and sample is not expressed in decimal places.
Impurity: Any impurity is expressed up to the third decimal place, e.g. 0.101, 0.50,0, etc., and rounded up.
Absorbance measured on the Spectrophotometer: Absorbance is expressed up to the third decimal place, e.g. 0.101, 0.500, etc.
Temperature and Humidity (Environment monitoring): Temperature and humidity is expressed as the actual temperature displayed on the thermometer.
pH: pH is expressed up to the second decimal place, e.g. 5.21.
Dissolution: In dissolution, the result should be calculated to one decimal place more than the significant figure stated and then rounded in under point 6.3.2.
Disintegration Time
The result for disintegration time should be expressed as. e. g. 1 Minutes 45 seconds.
Friability
The result for friability should be calculated to the second decimal place more than the significant figure stated and then rounded. e. g. 0.62 %.
Average Weight of tablets / Average volume of oral liquid
The average weight of tablets should be calculated to the first decimal place more than the significant figure stated and then rounded. e. g. 750.2 mg, 60.2 ml.
Average Weight of Sachets
The average weight of Sachets should be calculated to the first decimal place more than the significant figure stated and then rounded. e.g. 750.2 mg, 2 g.
Weight variation / Volume variation:
Weight variation/volume variation should be calculated to the second decimal place more than the significant figure stated and then rounded. e.g. 1.21 %. The individual weight of the tablet shall be taken as a whole number.
Deliverable volume:
Deliverable volume is expressed as the actual volume displayed on the measuring cylinder.
Uniformity of content :
In uniformity of content (in %) the result should be calculated to one decimal place more than the significant figure stated and then rounded e.g. 00% or 99%.
Weight per ml:
- Weight per ml should be calculated to the third decimal place more than the significant figure stated and then rounded e.g. 0.000mg/ml.
- Other results should be expressed according to its specification limit.
In-process Quality Assurance
- While performing IPQA checks, the readings for thickness and friability should be reported in two digits after the decimal.
- The hardness readings should be reported as per the values obtained from the hardness test apparatus.
- The results for LOD should be mentioned in two digits after the decimal. The second digit after the decimal should be rounded off to its next digit, if the third digit is 5 or greater than 5, and if the third digit after the decimal is less than 5, then the second digit should be kept as it is, omitting the third digit.
- The readings for individual tablet weight, and uniformity of weight should be reported in three digits after the decimal when the unit is a gram and in one digit after the decimal when the unit is a milligram. In the case of a gram, the third digit should be rounded off to the next digit when the fourth digit is 5 or greater than 5, and the third digit should be kept as it is when the fourth digit is less than 5, omitting the fourth digit. When the unit is a milligram, the weight should be reported in one digit after the decimal. The first digit after the decimal should be rounded off to the next digit when the second digit is 5 or greater than 5 and the first digit after the decimal should be kept as it is when the second digit is less than 5, omitting the second digit.
Warehouse
- The receipt quantity of the raw material should be registered in Three digits after the decimal. If the fourth digit is 5 or greater than 5, then the third digit should be rounded off to the next digit and if the fourth digit is less than 5 then the third digit should be kept as it is, omitting the fourth digit. e.g.
- If the receipt quantity of Starch is 50.0387 gm then it should be written as 50.039 gm (In this case Third digit 8 is rounded off to its next digit 7 as the fourth digit 7 is greater than 5).
- If the receipt quantity of Starch is 50.0344 gm then it should be written as 50.034 gm (In this case third digit 4 is written as it is because fourth digit 4 is less than 5).
