SOLITAIRE PHARMACIA PVT. LTD.
RESTRICTED CIRCULATION
AUTHORISED PERSONS ONLY
STANDARD OPERATING PROCEDURE
Title: Operation & Calibration of Analytical Balance
Prepared By
Concerned Dept
1.
Checked By
Concerned Dept
Reviewed By
QA
Approved By
QA-Head
SOP. No.
:
SPL/ SOP/QC/023
Page No.
:
1 of 3
Supersedes
:
New
Revision No.
:
00
Effective Date
Review Date
Objective
To define the procedure for Operating and Calibration procedure of Analytical Balance.
2.
Scope
This procedure is applicable to Quality Control department at Solitaire Pharmacia Pvt. Ltd.,
Baddi.
3.
Responsibility
Executive Quality Control
4.
Accountability
Head Quality Control
5.
Procedure
5.1.
Precautions:
5.1.1.
Clean the pan thoroughly prior to calibration.
5.1.2.
Check that the air bubble is in the center of the level & if necessary adjust the level by
turning the leveling SCREW.
5.1.3.
Switch “ON” the balance & allow it to stabilize for 15 minutes.
5.2.
Instrument Calibration:
5.2.1.
Ensure that the balance pan is not baded and the door of the weighing chamber is close
properly.
5.2.2.
Press the “CAL” button, the balance will display “CAL “.
5.2.3.
After few seconds the balance will display ”CAL SET” and then return to weight mode
and displayed as”0000” .
5.2.4.
Daily verification of the Analytical Balance:
Format No.SPL/QA/001
SOLITAIRE PHARMACIA PVT. LTD.
RESTRICTED CIRCULATION
AUTHORISED PERSONS ONLY
STANDARD OPERATING PROCEDURE
Title: Operation & Calibration of Analytical Balance
Prepared By
Concerned Dept
5.2.5.
Checked By
Concerned Dept
Reviewed By
QA
Approved By
QA-Head
SOP. No.
:
SPL/ SOP/QC/023
Page No.
:
2 of 3
Supersedes
:
New
Revision No.
:
00
Effective Date
Review Date
After internal calibration is completed verify the performance of the balance by
Weighing 10 mg, 50 mg, 100 mg; 1 gm and 200 gm. Record the result in Daily
verification log book.
5.2.6.
Calibration of measurement of uncertainty and drift of the Analytical Balance:
5.2.7.
Place 200mg standard calibrated weight on the pan.
5.2.8.
Record the display of the weight.
5.2.9.
Remove the weight & again place the weight on the pan & record the display once
again.
5.2.10.
Repeat the above operation to get ten readings Calculate the standard deviation of ten
readings.
5.2.11.
The measurement uncertainty shall be considered satisfactory if three times of standard
deviation of not less than 10 replicate weighing divided by amount weight does not
exceed 0.001. Record the observations in the calibration record.
5.2.12.
Now place 5.0 gm weight on the five different places as shown below to find the drift
and record the observation.
Format No.SPL/QA/001
SOLITAIRE PHARMACIA PVT. LTD.
RESTRICTED CIRCULATION
AUTHORISED PERSONS ONLY
STANDARD OPERATING PROCEDURE
Title: Operation & Calibration of Analytical Balance
Prepared By
Concerned Dept
6.
7.
Checked By
Concerned Dept
Reviewed By
QA
Approved By
QA-Head
SOP. No.
:
SPL/ SOP/QC/023
Page No.
:
3 of 3
Supersedes
:
New
Revision No.
:
00
Effective Date
Records/Formats:
SPL/QC/034
-
Log book for daily verification of analytical balance
SPL/QC/035
-
Log Book for balance
SPL/QC/036
-
Calibration of analytical balance
Annexure:
NA
8.
Reference:
Nil
9.
10.
Abbreviations:
SPL
-
Solitaire Pharmacia Pvt. Ltd., Baddi
QC
-
Quality Control
SOP
-
Standard Operating Procedure
Revision History:
Revision No
00
Format No.SPL/QA/001
Effective date
Reason for Revision
New Document
Review Date
SOLITAIRE PHARMACIA PVT. LTD.
RESTRICTED CIRCULATION
AUTHORISED PERSONS ONLY
STANDARD OPERATING PROCEDURE
Title: Operation & Calibration of Analytical Balance
SOP. No.
Prepared By
Concerned Dept
Checked By
Concerned Dept
Reviewed By
QA
:
SPL/ SOP/QC/023
Approved By
QA-Head
Log book for daily verification of analytical balance
Format No : SPL/QC/034
Date
10 mg
Format No.SPL/QA/001
50 mg
Standards Weights
100 mg
1 gm
Tolerance = ± 0.1 %
200 gm
Done By
Checked By
SOLITAIRE PHARMACIA PVT. LTD.
RESTRICTED CIRCULATION
AUTHORISED PERSONS ONLY
STANDARD OPERATING PROCEDURE
Title: Operation & Calibration of Analytical Balance
SOP. No.
Prepared By
Concerned Dept
Checked By
Concerned Dept
Reviewed By
QA
:
SPL/ SOP/QC/023
Approved By
QA-Head
Log book for Balance
Format No : SPL/QC/035
Sr.
No.
Operation Time
Date
Format No.SPL/QA/001
Product Name
Batch No.
On
Time
Off
Time
Weight
Taken
Operated
By
Check By
Remarks
SOLITAIRE PHARMACIA PVT. LTD.
RESTRICTED CIRCULATION
AUTHORISED PERSONS ONLY
STANDARD OPERATING PROCEDURE
Title: Operation & Calibration of Analytical Balance
SOP. No.
Prepared By
Concerned Dept
Checked By
Concerned Dept
Reviewed By
QA
Approved By
QA-Head
Calibration of analytical balance
Format No : SPL/QC/036
Date of Calibration:
Next Calibration:
Name of Instrument:
:
Analytical Balance
Make
:
Afcoset
Model No.
:
------------
User Department
:
Quality Control
Sensitivity
:
0.01 mg
Instrument Code
:
QCD/EBL/003
Calibration Schedule
:
Monthly
Measurement of Uncertainty:
Standard weight used
Sr. No.
:
200 mg
Observation
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Mean
SD
Measurement of Uncertainty: = 3 X SD
Weigh measured
Format No.SPL/QA/001
:
SPL/ SOP/QC/023
SOLITAIRE PHARMACIA PVT. LTD.
RESTRICTED CIRCULATION
AUTHORISED PERSONS ONLY
STANDARD OPERATING PROCEDURE
Title: Operation & Calibration of Analytical Balance
SOP. No.
Prepared By
Concerned Dept
Checked By
Concerned Dept
Reviewed By
QA
:
SPL/ SOP/QC/023
Approved By
QA-Head
Drift:
Standard weight used :
Sr. No.
5.0 gm
Observation
1.
2.
3.
4.
5.
Mean
RSD
Remarks: The instrument is working/not working under satisfactory condition.
Analyzed By:
Checked By:
Approved By:
Date
Date
Date
Format No.SPL/QA/001
:
:
:
0
