MAXTAR BIO-GENICS

Khasra No.: 705, Vill. MalkuMajra, Nalagarh Road, Baddi, Distt. Solan, H.P)

Operation Qualification Protocol Cum Report

Document No. MG/OQ/BAL-00 Page 1 of 11
Effective Date

OPERATION
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)

Operation Qualification Protocol Cum Report

Document No. MG/OQ/BAL-00 Page 2 of 11
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. Referred SOP Details 7
9. Abbreviation 8
10. List of Attachment 8
11. Deviation /Incident /OOS/OOT (Valid) 9
12. CAPA 9
13. Summary and conclusion 9
14. Post Approval 10

 Pre Approval :

Format No.: QAD/050-F01-00

 MAXTAR BIO-GENICS
Khasra No.: 705, Vill. MalkuMajra, Nalagarh Road, Baddi, Distt. Solan, H.P)

Operation Qualification Protocol Cum Report

Document No. MG/OQ/BAL-00 Page 3 of 11
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)

Operation Qualification Protocol Cum Report

Document No. MG/OQ/BAL-00 Page 4 of 11
Effective Date

The purpose of carrying out Operation Qualification of Weighing balance is to establish the
documented evidence that the system operates 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)

Operation Qualification Protocol Cum Report

Document No. MG/OQ/BAL-00 Page 5 of 11
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)

Operation Qualification Protocol Cum Report

Document No. MG/OQ/BAL-00 Page 6 of 11
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 :-

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 MAXTAR BIO-GENICS
Khasra No.: 705, Vill. MalkuMajra, Nalagarh Road, Baddi, Distt. Solan, H.P)

Operation Qualification Protocol Cum Report

Document No. MG/OQ/BAL-00 Page 7 of 11
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. Operation Verification Checks
7.1.1. Components verification :
Checked
Verified
Component Acceptance By.
Sr. No. Observation By.
Description criteria Sign./
Sign./date
date
Upon connecting
the power cord to
1. Switch ON main main switch
Supply power of
weighing balance
shall be on.
Switch Off the Main power
2. Main supply supply to
machine should
off.
Vibration during Should be free
3.
operation from vibration
Verify the Electricity should
4. supporting be single phase,
utilities 220 V-240V
5. Earthing should
Earthing
be provided
Self test and
Weight should be
6. subsequently
shown on the
check weight is
machine.
shown on display

Format No.: QAD/050-F01-00

 MAXTAR BIO-GENICS
Khasra No.: 705, Vill. MalkuMajra, Nalagarh Road, Baddi, Distt. Solan, H.P)

Operation Qualification Protocol Cum Report

Document No. MG/OQ/BAL-00 Page 8 of 11
Effective Date

8. REFFERED SOP DETAILS:

SOP NAME SOP No.

9. ABBREVIATION:

Abbreviation Detail

OQ Operation Qualification

QA Quality Assurance

ID Identification

Sr.No. 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)

Operation Qualification Protocol Cum Report

Document No. MG/OQ/BAL-00 Page 9 of 11
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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)

Operation Qualification Protocol Cum Report

Document No. MG/OQ/BAL-00 Page 10 of 11
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)

Operation Qualification Protocol Cum Report

Document No. MG/OQ/BAL-00 Page 11 of 11
Effective Date

Approved By:

Name Designation Department Signature Date

Format No.: QAD/050-F01-00