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Performance Qualification Protocol Cum OF Weighing Balance: Document No. MG/PQ/BAL-00 Page 1 of 12 Effective Date
Performance Qualification Protocol Cum OF Weighing Balance: Document No. MG/PQ/BAL-00 Page 1 of 12 Effective Date
Performance Qualification Protocol Cum OF Weighing Balance: Document No. MG/PQ/BAL-00 Page 1 of 12 Effective Date
Khasra No.: 705, Vill. MalkuMajra, Nalagarh Road, Baddi, Distt. Solan, H.P)
PERFORMANCE
QUALIFICATION PROTOCOL CUM
REPORT
OF
WEIGHING BALANCE
EQUIPMENT NAME WEIGHING BALANCE
MAKE SAMSON
CAPACITY 300 GM
TABLE OF CONTENTS
Pre Approval :
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:
Reviewed By:
Approved By:
1. OBJECTIVE:
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.
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)
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/
6. SYSTEM DESCRIPTION:
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:-
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 :-
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.
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.
9. ABBREVIATION:
Abbreviation Detail
PQ Performance Qualification
QA Quality Assurance
ID Identification
HP Horse power
Hz Hertz
RH Relative humidity
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12. CAPA:
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Prepared By
Reviewed By:
Approved By: