MAXTAR BIO-GENICS
Khasra No.: 705, Vill. MalkuMajra, Nalagarh Road, Baddi, Distt. Solan, H.P)
Installation Qualification Protocol Cum Report
Document No. MG/IQ/BAL-00 Page 1 of 12
Effective Date
INSTALLATION
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)
Installation Qualification Protocol Cum Report
Document No. MG/IQ/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 6-7
8. Installation Qualification Checks 8-9
9. Referred SOP Details 11
10. Abbreviation 11
11. List of Attachment 11
12. Deviation /Incident /OOS/OOT (Valid) 12
13. CAPA 12
14. Summary and conclusion 12
15. Post Approval 13
Pre Approval :
Format No.: QAD/050-F01-00
MAXTAR BIO-GENICS
Khasra No.: 705, Vill. MalkuMajra, Nalagarh Road, Baddi, Distt. Solan, H.P)
Installation Qualification Protocol Cum Report
Document No. MG/IQ/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)
Installation Qualification Protocol Cum Report
Document No. MG/IQ/BAL-00 Page 4 of 12
Effective Date
The purpose of carrying out Installation Qualification of Weighing balance is to establish the
documented evidence that the system installation is in accordance with the pre-defined
specifications.
2. SCOPE:
This qualification protocol should be generated for qualification of weighing balance located in at
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)
Installation Qualification Protocol Cum Report
Document No. MG/IQ/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)
Installation Qualification Protocol Cum Report
Document No. MG/IQ/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)
Installation Qualification Protocol Cum Report
Document No. MG/IQ/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:
7.1. Installation verification
7.1.1. Components verification :
Checked
Verified
Component Acceptance By.
Sr. No. Observation By.
Description criteria Sign./
Sign./date
date
Machine should
have
Positioning of the enough space
1.
equipment around the other
equipment &
machines.
Name of the
equipmnt and or
2. Identification plate suppliers name to be
available on the
equipment.
Any No physical
3. Physical damage to scratches or damage
the equipment. should be observed.
4. Any risk to of Verify that
electrical shock weighing balance
is securely
Format No.: QAD/050-F01-00
MAXTAR BIO-GENICS
Khasra No.: 705, Vill. MalkuMajra, Nalagarh Road, Baddi, Distt. Solan, H.P)
Installation Qualification Protocol Cum Report
Document No. MG/IQ/BAL-00 Page 8 of 12
Effective Date
Checked
Verified
Component Acceptance By.
Sr. No. Observation By.
Description criteria Sign./
Sign./date
date
anchored and
shock proof.
Verify that all
Inappropriate
5. electrical
Electrical
connections are
connections
done properly
Instrument is
6. Excessive vibration free and
vibration & noice there is no any
abnormal sound.
8. INSTALLATION QUALIFICATION CHECKS :
TECHNICAL SPECIFICATION
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
Format No.: QAD/050-F01-00
MAXTAR BIO-GENICS
Khasra No.: 705, Vill. MalkuMajra, Nalagarh Road, Baddi, Distt. Solan, H.P)
Installation Qualification Protocol Cum Report
Document No. MG/IQ/BAL-00 Page 9 of 12
Effective Date
7. Supply Voltage :- 220 Volts, A.C.
8. Supply Frequency : 50 Hz
9. REFFERED SOP DETAILS:
SOP NAME SOP No.
10. ABBREVIATION:
Abbreviation Detail
IQ Installation Qualification
QA Quality Assurance
ID Identification
RPM Rotation per minute
SS Stainless Steel
[Link]. Serial Number
HP Horse power
MM Milli meter
11. LIST OF ATTACHMENT
Format No.: QAD/050-F01-00
MAXTAR BIO-GENICS
Khasra No.: 705, Vill. MalkuMajra, Nalagarh Road, Baddi, Distt. Solan, H.P)
Installation Qualification Protocol Cum Report
Document No. MG/IQ/BAL-00 Page 10 of 12
Effective Date
Sr. No. Details of attachment
12. DEVIATION/INCIDENT/OOS/OOT (VALID):
_________________________________________________________________________________
_________________________________________________________________________________
Sign/date:
13. CAPA:
_________________________________________________________________________________
_________________________________________________________________________________
Sign/date:
14. SUMMARY AND CONCLUSION:
Format No.: QAD/050-F01-00
MAXTAR BIO-GENICS
Khasra No.: 705, Vill. MalkuMajra, Nalagarh Road, Baddi, Distt. Solan, H.P)
Installation Qualification Protocol Cum Report
Document No. MG/IQ/BAL-00 Page 11 of 12
Effective Date
___________________________________________________________________________________
___________________________________________________________________________________
___________________________________________________________________________________
___________________________________________________________________________________
__________________________________________________________________________________
__________________________________________________________________________________
__________________________________________________________________________________
__________________________________________________________________________________
Sign/date
15. 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)
Installation Qualification Protocol Cum Report
Document No. MG/IQ/BAL-00 Page 12 of 12
Effective Date
Approved By:
Name Designation Department Signature Date
Format No.: QAD/050-F01-00
