10 KG Weighing Balance (XL-WH-WB-001) ... IOQ

XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India

TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 1 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:
TABLE OF CONTENT
SL. NO. SUBJECT PAGE NO.
1. Preapproval 2
2. Objective 3
3. Scope 3
4. Responsibility 3
5. Acceptance Criteria 4
6. Installation Verification 4
7. Operational Verification 8
8. Deficiency and Corrective Action Taken 11
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9. Requalification Criteria 11
10. Combined Installation/Operation Qualification Report 12
11. List Of Annexure 13
12. Reference 13
13. Post approval 14
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1.0 PRE APPROVAL:

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This protocol for Combined Installation/Operation Qualification (IOQ) of Weighing Balance

(Equipment ID: XL/WH/WB/01) to be used for weighing of material in Store department has
been Prepared, checked, reviewed and approved in accordance with standards and adequately
reflects the tasks and deliverables necessary for Installation/Operation Qualification of the
equipment/Instrument / System.
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The signature by below mentioned persons indicates that the documentation and information
contained herein complies with applicable regulatory, corporate, divisional/departmental
requirements, and current Good Manufacturing Practices.
Prepared by : Quality Assurance

Name Designation Sign/Date
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Reviewed by : Engineering
Reviewed by : Store
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Reviewed by : Quality Assurance

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Approved by : Quality Assurance

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2.0 OBJECTIVE:
The objective of this document is to provide a written guideline for the execution of the
Combined Installation/Operation Qualification (IOQ) of Weighing Balance for static attribute to
verify that:
The Instrument / equipment have been installed in accordance with the design and user
requirements and meet the set acceptance criteria and cGMP requirements as stipulated in
this document.
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Each installed components complies with the engineering design and equipment data
sheets / specification.
All supporting utilities are properly connected & equipment operations are verified for its
intended use.
3.0 SCOPE:
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The Scope of this protocol is limited to the Combined Installation/Operation Qualification (IOQ)
of Weighing Balance (Equipment ID: XL/WH/WB/01) is safely installed in Store department
(Powder Dispensing Room) at XL Laboratories Pvt. Ltd., Neemrana.
4.0 RESPONSIBILITY:
Responsibilities of different department / personnel involved in different activities related to the
Combined Installation/Operation Qualification of the Weighing Balance are defined below:
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Functions Responsible
Preparation of protocol Quality Assurance officer/ executive
Review of the protocol Quality Assurance, Engineering & Store department

Approval of the protocol Head Quality assurance
Execution of activity as per
Quality Assurance, Engineering & Store department
protocol
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Functions Responsible
Preparation of report Quality Assurance officer/executive

Approval of the Executed protocol
Head Quality assurance
and report
5.0 ACCEPTANCE CRITERIA:

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5.1 The equipment shall be complying with the specification.

5.2 All supporting utilities of specified capacities are to be near the place of installation.
5.3 All the specified installation checks are to be complied.
5.4 The equipment and its components shall be operated as per its specified operating instructions
mentioned in the protocol.
5.5 All SOPs for the equipment should be checked and verified.
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5.6 All the functionality of equipment components, safety features, Utility requirements to be
checked and verified.
6.0 INSTALLATION VERIFICATION:
EQUIPMENT DESCRIPTION
Equipment Name : Weighing Balance
Equipment ID : XL/WH/WB/01
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6.1 Instruction of filling Checklist:
For Installation Checklist of the equipment and utilities use the word yes to show
its presence and use No to indicate the absence.
For identification of the components of the equipment and utilities use the word
Comply otherwise use Does not comply to indicate non-compliance along with
mode of verification.
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Give the detailed information in the summary and conclusion part of the Installation
Qualification report.
Whichever column is blank or not used NA shall be used.
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6.2 Installation Checklist:

Installation checklist is as follows:
Checked By Verified By
Sr. No. Statement Yes / No
(Sign/Date) (Sign/Date)
Verify that weighing balance is securely
01 anchored and shock proof.
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Verify that there is no observable physical

02 damage.
Verify that all electrical connections are done
03
properly
04 Safe electrical connections.
Equipment is Vibration Free and there is no
05
any abnormal sound.
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________________________________________________________________________________________________________________________________________________________________________________________________________
________________________________________________________________________________________________________________________________________________________________________________________________________
Verified By (Sign/Date)
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6.3 Verification of Equipment Description:
Equipment : Weighing Balance

Equipment ID : XL/WH/WB/01
Location : Powder Dispensing Room
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Sr. Equipment/ Checked Verified By

No. Components By (Sign/Date)
Specification Actual Observation
(Sign/Date
)
1 Manufacturer Contech Instrument Ltd.
2 Model CTT-10K1
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3 Serial No. 1567671

4 Capacity 10 Kg
Powder Dispensing
5 Location
Room
6 Platform Size 190 mm X 250 mm
7 Accuracy 1g
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Minimum: 20 g
8 Working Range
Maximum: 10 kg
________________________________________________________________________________________________________________________________________________________________________________________________________
________________________________________________________________________________________________________________________________________________________________________________________________________
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6.4 Identification of supporting utility:
Properly Identified & Checked By Verified By

UTILITY
Connected (Yes/No) (Sign/Date) (Sign/Date)
Electricity: Single phase, 220 - 240 V
________________________________________________________________________________________________________________________________________________________________________________________________________
________________________________________________________________________________________________________________________________________________________________________________________________________
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6.5 Identification of Safety Features:
Safety
Sr. No. Features Function
Description
1. Earthing To avoid electrical shocks
________________________________________________________________________________________________________________________________________________________________________________________________________
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________________________________________________________________________________________________________________________________________________________________________________________________________
6.6 Identification of Standard Operating Procedure:
The following Standard Operating Procedures were identified as important for effective
Operation & performance of Weighing Balance.
Identified By Verified By
Sr. No. SOP Title
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1. Operation & Cleaning of Weighing Balance.
________________________________________________________________________________________________________________________________________________________________________________________________________
________________________________________________________________________________________________________________________________________________________________________________________________________
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7.0 OPERATIONAL VERIFICATION:

7.1 Instruction for filling the checklist:
In case of the compliance of the Operational test use either comply or actual
function/operation/value to show its presence/completion and use Not comply to indicate the
absence of the identity or Non conformance.
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Give the detailed information in the summary and conclusion part of the Operational
qualification report.
7.2 Operational Qualification Test:
Comply / Checked
Sr. No. Functions/ Parameter Acceptance Criteria Date
Not Comply By (Sign)
Main Power supply to
On switching Main
1. machine
Switch to On position
should on
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Main Power supply to

Off switching Main
2. machine
Switch to off position
should off
Vibration during Should be free from
3.
operation vibration
________________________________________________________________________________________________________________________________________________________________________________________________________
________________________________________________________________________________________________________________________________________________________________________________________________________
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7.3 Verification of supporting utility:
UTILITY Observation
Electricity: Single phase, 220V-240V
________________________________________________________________________________________________________________________________________________________________________________________________________
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________________________________________________________________________________________________________________________________________________________________________________________________________
\
7.4 Verification of Safety Features:

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Safety Features Checked By Verified By

Sr. No. Function
Description (Sign/Date) (Sign/Date)
1. Earthing To avoid electrical shocks

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Connect the Power Power of weighing balance shall

be ON.
Cord to the mains
2.
outlet and switch on
the mains power
Self test and The instrument goes through the
subsequently display self-test and subsequently
3.
weight after ON the displays weight.
machine.
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________________________________________________________________________________________________________________________________________________________________________________________________________
________________________________________________________________________________________________________________________________________________________________________________________________________
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7.5 Operational Test
S. Test Acceptance Criteria Actual observations

System description
No.
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A mass at least 50% of Result should be

the maximum load is consistent.
1 Repeatability Test weighed repeatedly
and checked for
consistency.
A mass at least 30% of Result should be
the maximum load is consistent.
2 Corner Load Test weighed on all 4 sides
of the weighing pan
area.
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Different masses Result should be

ranging from consistent.
3 Accuracy Test minimum load to
maximum load area
weighed for accuracy.
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This test involves the A mass should weigh

use of 2 masses of same at all regions
50% of the maximum within the capacity of
4 Linearity Test
capacity for checking the instrument.
the non linearity of the
instrument.
________________________________________________________________________________________________________________________________________________________________________________________________________
________________________________________________________________________________________________________________________________________________________________________________________________________
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Checked By (Sign/Date) Verified By (Sign/Date)

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7.6 Verification of Standard Operating Procedure:

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Availability Checked By Verified By

Sr. No. SOP Title
(Yes/No) (Sign/Date) (Sign/Date)
Operation & Cleaning of Weighing
1.
Balance
_______________________________________________________________________________________________________________________________________________________________________________________________________
________________________________________________________________________________________________________________________________________________________________________________________________________
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8.0 DEFICIENCY AND CORRECTIVE ACTION TAKEN
Following deficiency was identified and corrective actions taken in consultation with the
Engineering Department.
Description of deficiency:
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_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Corrective Action(s) Taken:
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
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9.0 REQUALIFICATION CRITERIA:
The Weighing Balance has to be Requalified if:
There are any major changes which affect the operation of the equipment.
After major breakdown maintenance is carried out.
As per Requalification Frequency.
Transfer/Shifting of Equipment.
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10.0 COMBINED INSTALLATION/OPERATION QUALIFICATION REPORT:
Summary:
_____________________________________________________________________________
_____________________________________________________________________________
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_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
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_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Conclusion:
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
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_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
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Compiled By: Checked By:

(Sign & Date) (Sign & Date)
11.0 LIST OF ANNEXURE:

Page 56 of 64
SL. NO. DETAILS OF ANNEXURES

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12.0 REFERENCE:
1. EudraLex Volume 4 (Annex 15: Qualification and Validation)
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2. SOP/QA/028
3. SOP/QA/056
13.0 POST APPROVAL:
This report for Weighing Balance Combined Installation/Operation Qualification has been
Prepared, reviewed and Approved by the following persons.
Page 61 of 64
The reviewers & approvers signature indicates that this document has been reviewed, approved
and it accurately and completely reflects the tasks and deliverables necessary for installation &
operation Qualification of the equipment / Instrument / System, and the documentation and
information contained herein complies with applicable regulatory, corporate, divisional /
departmental requirements and current Good Manufacturing Practices.
Reviewed by : Engineering
Page 62 of 64
Reviewed by : Store
Reviewed by : Quality Assurance

Page 63 of 64
Approved by : Quality Assurance

Page 64 of 64

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XL LABORATORIES PVT. LTD.

A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India

1.0 PRE APPROVAL:

This protocol for Combined Installation/Operation Qualification (IOQ) of Weighing Balance

Prepared by : Quality Assurance

Name Designation Sign/Date

Reviewed by : Quality Assurance

Approved by : Quality Assurance

Preparation of protocol Quality Assurance officer/ executive

Review of the protocol Quality Assurance, Engineering & Store department

Preparation of report Quality Assurance officer/executive

5.0 ACCEPTANCE CRITERIA:

5.1 The equipment shall be complying with the specification.

6.0 INSTALLATION VERIFICATION:

6.1 Instruction of filling Checklist:

6.2 Installation Checklist:

Verify that there is no observable physical

6.3 Verification of Equipment Description:

Equipment : Weighing Balance

Sr. Equipment/ Checked Verified By

3 Serial No. 1567671

6.4 Identification of supporting utility:

Properly Identified & Checked By Verified By

1. Operation & Cleaning of Weighing Balance.

7.0 OPERATIONAL VERIFICATION:

Main Power supply to

7.3 Verification of supporting utility:

7.4 Verification of Safety Features:

Safety Features Checked By Verified By

1. Earthing To avoid electrical shocks

Connect the Power Power of weighing balance shall

7.5 Operational Test

S. Test Acceptance Criteria Actual observations

A mass at least 50% of Result should be

Different masses Result should be

This test involves the A mass should weigh

Checked By (Sign/Date) Verified By (Sign/Date)

7.6 Verification of Standard Operating Procedure:

Availability Checked By Verified By

9.0 REQUALIFICATION CRITERIA:

The Weighing Balance has to be Requalified if:

10.0 COMBINED INSTALLATION/OPERATION QUALIFICATION REPORT:

Compiled By: Checked By:

11.0 LIST OF ANNEXURE:

SL. NO. DETAILS OF ANNEXURES

13.0 POST APPROVAL:

Reviewed by : Quality Assurance

Name Designation Sign/Date

Approved by : Quality Assurance

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