CELEBRITY BIOPHARMA LIMITED

Format No.: QAS001/F/01/00Reference SOP No.: SOP/QA/001/00

STANDARD OPERATING PROCEDURE
Location Quality Assurance SOP Number SOP/QA/048/00
Version 00
Superseded SOP No. Nil
Title Rounding of significant figures Effective Date
Review Date
Page Number 1 of 3
1. OBJECTIVE
1.1 Todescribea procedure forrounding of Significant figures.
2. SCOPE
2.1 This procedure is applicable for calculated values or results generated at all departments at
Celebrity Biopharma Limited.
3. RESPONSIBILITY
3.1 Every individual of the plant involved in recording of values/ calculations shall follow this
SOP.
3.2 QA Head shall responsible for compliance with this procedure.
4. PROCEDURE
4.1 Calculated results obtained are compared with specifications to determine the rounding
that is appropriate and the significant figures to be reported.
4.2 Follow the SOP ‘Good Documentation Practices’ as per SOP No.: SOP/QA/013/00.
4.3 The reported values with the correct significant figures shall meet the requirements of
rounding and comply with the specifications.
4.4 Values obtained from instruments may be automatically printed by the instrument and
contain more significant figures than those mentioned in the specification or stated limit.
4.5 Rounding to the same significant figures as given in the document or stated limit occurs
with the reporting of the final result.
4.6 Rounding considers only one digit in the decimal place to the right of the last place in the
specification or stated limit:
Record all numbers to the appropriate number of significant figures should be determined
from the document, SOP or method being used. For example: If a limit in a document is
defined as 0.45% to 0.55% then the result should be reported to two decimal places

Name Designation Signature Date Stamp

Prepared by
Checked by
Approved
by
Authorized
by
 CELEBRITY BIOPHARMA LIMITED
Format No.: QAS001/F/01/00Reference SOP No.: SOP/QA/001/00
STANDARD OPERATING PROCEDURE
Location Quality Assurance SOP Number SOP/QA/048/00
Version 00
Superseded SOP No. Nil
Title Rounding of significant figures Effective Date
Review Date
Page Number 2 of 3
(significant figures). If the limit is expressed as 0.450% to 0.550%, then the result should
be reported to three decimal places.
4.7 When rounding is required, consider only one digit in the decimal place to the right of the
last place in the limit expression. If the digit is smaller than 5, it is eliminated and the
preceding digit is unchanged. If the digit is greater than or equal to 5, it is eliminated and
the preceding digit is increased by one.
For example: If a limit test was less than or equal to 0.02%
Then, 0.025% becomes 0.03%
0.015% becomes 0.02%
0.024% becomes 0.02%
5. RELATED DOCUMENTS
5.1 SOP No.: SOP/QA/013/00 : Good Documentation Practices
6. REFERENCES
6.1 Nil
7. RECORDS
7.1 Nil
8. ABBREVIATIONS
8.1 SOP : Standard Operating Procedure
8.2 QA : Quality Assurance
8.3 % : Percentage
9. REVISION RECORD
Version Reason for Revision Effective Date
00 New SOP --------
Name Designation Signature Date Stamp
Prepared by
Checked by
Approved
by
Authorized
by
 CELEBRITY BIOPHARMA LIMITED
Format No.: QAS001/F/01/00Reference SOP No.: SOP/QA/001/00
STANDARD OPERATING PROCEDURE
Location Quality Assurance SOP Number SOP/QA/048/00
Version 00
Superseded SOP No. Nil
Title Rounding of significant figures Effective Date
Review Date
Page Number 3 of 3

END OF DOCUMENT

Name Designation Signature Date Stamp

Prepared by
Checked by
Approved
by
Authorized
by