MAXTAR BIO-GENICS
Khasra No.: 705, Vill. MalkuMajra, Nalagarh Road, Baddi, Distt. Solan, H.P)
Performance Qualification Protocol Cum Report
Document No. MG/PQ/BAL-00 Page 1 of 12
Effective Date
PERFORMANCE
QUALIFICATION PROTOCOL CUM
REPORT
OF
WEIGHING BALANCE
EQUIPMENT NAME WEIGHING BALANCE
MAKE SAMSON
CAPACITY 300 GM
LOCATION General Block
TABLE OF CONTENTS
Format No.: QAD/050-F01-00
MAXTAR BIO-GENICS
Khasra No.: 705, Vill. MalkuMajra, Nalagarh Road, Baddi, Distt. Solan, H.P)
Performance Qualification Protocol Cum Report
Document No. MG/PQ/BAL-00 Page 2 of 12
Effective Date
Sr. No. Contents Page No.
Cover Page 1
Table of Contents 2
Pre-Approval 3
1. Objective 4
2. Scope 4
3. Responsibility 4
4. Validation Team 5
5. Training 5
6. System Description 6
7. Methodology for Qualification 7-8
8. Referred SOP Details 8
9. Abbreviation 9
10. List of Attachment 9
11. Deviation /Incident /OOS/OOT (Valid) 10
12. CAPA 10
13. Summary and conclusion 10
14. Post Approval 11
Pre Approval :
Format No.: QAD/050-F01-00
MAXTAR BIO-GENICS
Khasra No.: 705, Vill. MalkuMajra, Nalagarh Road, Baddi, Distt. Solan, H.P)
Performance Qualification Protocol Cum Report
Document No. MG/PQ/BAL-00 Page 3 of 12
Effective Date
The Signature on this approval page indicates that the signatories have gone through this Qualification
Protocol cum protocol completely and assures that the protocol fulfill all the requirements as per the
Regulatory guidelines.
Prepared By:
Name Department Designation Signature Date
Reviewed By:
Name Department Designation Signature Date
Approved By:
Name Department Designation Signature Date
1. OBJECTIVE:
Format No.: QAD/050-F01-00
MAXTAR BIO-GENICS
Khasra No.: 705, Vill. MalkuMajra, Nalagarh Road, Baddi, Distt. Solan, H.P)
Performance Qualification Protocol Cum Report
Document No. MG/PQ/BAL-00 Page 4 of 12
Effective Date
The purpose of carrying out Performance Qualification of Weighing balance is to establish the
documented evidence that the system performing is in accordance with the pre-defined
specifications.
2. SCOPE:
This qualification protocol should be generated for qualification of weighing balance located in
Maxtar Bio-Genics Baddi.
3. RESPONSIBILITY:
Sr.
Department Responsibility
No.
To prepare, review and approve the Qualification protocol cum report.
Quality To ensure operation of the machine as per relevant SOP.
1.
Assurance Involved in Training & execution of Qualification activity.
To prepare & compile the summary report conclusion & Recommendations.
Review the Qualification protocol cum report.
To ensure the operation of machine as per relevant SOP.
2. Production
Involved in execution of Qualification activity.
To provide support in execution of Qualification activity.
Quality To review Qualification protocol cum report.
3.
Control
Analysis of Qualification samples and report submission.
To provide support in execution of Qualification activity.
To get involved in the Qualification activity.
4. Engineering
To ensure the availability of all required utilities during
Qualification activity.
4. VALIDATION TEAM:
Format No.: QAD/050-F01-00
MAXTAR BIO-GENICS
Khasra No.: 705, Vill. MalkuMajra, Nalagarh Road, Baddi, Distt. Solan, H.P)
Performance Qualification Protocol Cum Report
Document No. MG/PQ/BAL-00 Page 5 of 12
Effective Date
Sr. No. Name of person Name of department Designation
5. TRAINING:
The purpose of the training is to aware the team members who will get take part in the Qualification
execution, documentation procedure and overall strategy of process.
Training Feedback
Name Department Signature Date
Understood/
Trainer Name : Sign/Date:
6. SYSTEM DESCRIPTION:
Format No.: QAD/050-F01-00
MAXTAR BIO-GENICS
Khasra No.: 705, Vill. MalkuMajra, Nalagarh Road, Baddi, Distt. Solan, H.P)
Performance Qualification Protocol Cum Report
Document No. MG/PQ/BAL-00 Page 6 of 12
Effective Date
AREA
EQUIPMENT CODE No.
MODEL No.
6.1. USE:-
Weighing balances are piece of lab equipment that is generally used to precisely measure the
weight of materials. The maximum capacity of this balance is 300 gm having accuracy level of
0.001 gm. The technical specifications of this balance are as follows:-
Sr. No. Technical specification
1.
Maximum capacity- 300 gm
2.
Least Count - 0.01 gm
3.
Tare range- (by substraction) FULL CAPACITY
4.
Response Time : 3-5 Sec
5.
Working Temperature- 5-40 °C
6.
Humidity- <45% to 85% RH
7.
Supply Voltage :- 220 Volts, A.C.
8.
Supply Frequency : 50 Hz
6.2. PRINCIPLE :-
Format No.: QAD/050-F01-00
MAXTAR BIO-GENICS
Khasra No.: 705, Vill. MalkuMajra, Nalagarh Road, Baddi, Distt. Solan, H.P)
Performance Qualification Protocol Cum Report
Document No. MG/PQ/BAL-00 Page 7 of 12
Effective Date
The principle behind weighing balances is based on the concept of balance of weight. This means
that the weight of an object is balanced against a known weight, such as a set of calibrated weights
until equilibrium is reached. The balance then displays the weight of the object being measured.
7. METHODOLOGY FOR QUALIFICATION:
Frequency of Qualification/Calibration:-
Ensure that qualification /calibration of balances is done on receipt (i.e. immediately after
delivery) or prior to their first use and after any repair or move.
Verification of operational performance:
7.1.1. Components verification :
Checked Verified
Component Acceptance By. By.
Sr. No. Test Method Observation
Description criteria Sign./ Sign./
date date
Check the off center
error (shift error) by
Off Centre
using the 5%, 20%, ± 0.1% of
1. Error
50%, 75% & 80% of Actual
(Shift
balance capacity and Weight
Error)
take the reading from
05 locations
Check the drift by
using 5% weight of ± 0.2 mg of
2. Drift balance capacity and Actual
take the reading from weight
05 locations
3. Uncertaint Depending upon the Not more
y working range of than 0.001
balance select 03 % of Actual
weights (5%, 50% & Weight
80% of balance
capacity) and then
Format No.: QAD/050-F01-00
MAXTAR BIO-GENICS
Khasra No.: 705, Vill. MalkuMajra, Nalagarh Road, Baddi, Distt. Solan, H.P)
Performance Qualification Protocol Cum Report
Document No. MG/PQ/BAL-00 Page 8 of 12
Effective Date
Checked Verified
Component Acceptance By. By.
Sr. No. Test Method Observation
Description criteria Sign./ Sign./
date date
place them one by
one on the plate
form. Repeat the
steps 10 times & then
calculate the standard
deviation (SD) of 10
readings. Calculate
the uncertainty by
using the formula
(SD X 3 / Mean
weight)
Air bubble
Spirit level Check the leveling of
4. shall be centre
verification the equipment on level
position of
. indicator
level indicator.
Bench top
or floor
shall be
steady/ even
5. Placing Location should be
surface &
Location adequate.
shall be free
from head
vibration &
moisture.
Verificatio Standard
6. n of Check the calibration of weights
standard standard weights should be
weights calibrated.
8. REFFERED SOP DETAILS:
SOP NAME SOP No.
Format No.: QAD/050-F01-00
MAXTAR BIO-GENICS
Khasra No.: 705, Vill. MalkuMajra, Nalagarh Road, Baddi, Distt. Solan, H.P)
Performance Qualification Protocol Cum Report
Document No. MG/PQ/BAL-00 Page 9 of 12
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9. ABBREVIATION:
Abbreviation Detail
PQ Performance Qualification
QA Quality Assurance
ID Identification
[Link]. Serial Number
HP Horse power
Hz Hertz
SOP Standard Operating Procedure
RH Relative humidity
10. LIST OF ATTACHMENT
Sr. No. Details of attachment
Format No.: QAD/050-F01-00
MAXTAR BIO-GENICS
Khasra No.: 705, Vill. MalkuMajra, Nalagarh Road, Baddi, Distt. Solan, H.P)
Performance Qualification Protocol Cum Report
Document No. MG/PQ/BAL-00 Page 10 of 12
Effective Date
11. DEVIATION/INCIDENT/OOS/OOT (VALID):
_________________________________________________________________________________
_________________________________________________________________________________
Sign/date:
12. CAPA:
_________________________________________________________________________________
_________________________________________________________________________________
Sign/date:
13. SUMMARY AND CONCLUSION:
___________________________________________________________________________________
___________________________________________________________________________________
Format No.: QAD/050-F01-00
MAXTAR BIO-GENICS
Khasra No.: 705, Vill. MalkuMajra, Nalagarh Road, Baddi, Distt. Solan, H.P)
Performance Qualification Protocol Cum Report
Document No. MG/PQ/BAL-00 Page 11 of 12
Effective Date
___________________________________________________________________________________
___________________________________________________________________________________
__________________________________________________________________________________
__________________________________________________________________________________
__________________________________________________________________________________
__________________________________________________________________________________
Sign/date
14. POST APPROVAL:
Prepared By
Name Designation Department Signature Date
Reviewed By:
Name Designation Department Signature Date
Format No.: QAD/050-F01-00
MAXTAR BIO-GENICS
Khasra No.: 705, Vill. MalkuMajra, Nalagarh Road, Baddi, Distt. Solan, H.P)
Performance Qualification Protocol Cum Report
Document No. MG/PQ/BAL-00 Page 12 of 12
Effective Date
Approved By:
Name Designation Department Signature Date
Format No.: QAD/050-F01-00
