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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
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 2 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

9. Requalification Criteria 11
10. Combined Installation/Operation Qualification Report 12
11. List Of Annexure 13
12. Reference 13
13. Post approval 14
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 3 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 4 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

1.0 PRE APPROVAL:


XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 5 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

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.
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 6 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

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
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 7 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

Reviewed by : Engineering
Name Designation Sign/Date

Reviewed by : Store
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 8 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

Name Designation Sign/Date

Reviewed by : Quality Assurance


Name Designation Sign/Date
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
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Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

Approved by : Quality Assurance


Name Designation Sign/Date
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 10 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

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.
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 11 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

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:
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 12 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

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:
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 13 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

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
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 14 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

Functions Responsible

Preparation of report Quality Assurance officer/executive


Approval of the Executed protocol
Head Quality assurance
and report

5.0 ACCEPTANCE CRITERIA:


XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 15 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

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.
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 16 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

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
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 17 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

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.
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 18 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

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.
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 19 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

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.
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
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Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

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.
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 21 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

________________________________________________________________________________________________________________________________________________________________________________________________________

________________________________________________________________________________________________________________________________________________________________________________________________________

Verified By (Sign/Date)
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 22 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 23 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

6.3 Verification of Equipment Description:

Equipment : Weighing Balance


Equipment ID : XL/WH/WB/01
Location : Powder Dispensing Room
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 24 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

Sr. Equipment/ Checked Verified By


No. Components By (Sign/Date)
Specification Actual Observation
(Sign/Date
)
1 Manufacturer Contech Instrument Ltd.

2 Model CTT-10K1
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 25 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

3 Serial No. 1567671


4 Capacity 10 Kg
Powder Dispensing
5 Location
Room
6 Platform Size 190 mm X 250 mm

7 Accuracy 1g
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 26 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

Minimum: 20 g
8 Working Range
Maximum: 10 kg

________________________________________________________________________________________________________________________________________________________________________________________________________

________________________________________________________________________________________________________________________________________________________________________________________________________

Verified By (Sign/Date)
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 27 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 28 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

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

________________________________________________________________________________________________________________________________________________________________________________________________________

________________________________________________________________________________________________________________________________________________________________________________________________________
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 29 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

Verified By (Sign/Date)
6.5 Identification of Safety Features:

Safety
Checked By Verified By
Sr. No. Features Function
(Sign/Date) (Sign/Date)
Description
1. Earthing To avoid electrical shocks

________________________________________________________________________________________________________________________________________________________________________________________________________
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 30 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

________________________________________________________________________________________________________________________________________________________________________________________________________

Verified By (Sign/Date)
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
(Sign/Date) (Sign/Date)
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 31 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

1. Operation & Cleaning of Weighing Balance.

________________________________________________________________________________________________________________________________________________________________________________________________________

________________________________________________________________________________________________________________________________________________________________________________________________________

Verified By (Sign/Date)
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 32 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

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.
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 33 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

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
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
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Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

Main Power supply to


Off switching Main
2. machine
Switch to off position
should off
Vibration during Should be free from
3.
operation vibration

________________________________________________________________________________________________________________________________________________________________________________________________________

________________________________________________________________________________________________________________________________________________________________________________________________________
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
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Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

Verified By (Sign/Date)

7.3 Verification of supporting utility:

Checked By Verified By
UTILITY Observation
(Sign/Date) (Sign/Date)
Electricity: Single phase, 220V-240V

________________________________________________________________________________________________________________________________________________________________________________________________________
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
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Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

________________________________________________________________________________________________________________________________________________________________________________________________________

Verified By (Sign/Date)
\

7.4 Verification of Safety Features:


XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 37 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

Safety Features Checked By Verified By


Sr. No. Function
Description (Sign/Date) (Sign/Date)

1. Earthing To avoid electrical shocks


XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 38 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

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.
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
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Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

________________________________________________________________________________________________________________________________________________________________________________________________________

________________________________________________________________________________________________________________________________________________________________________________________________________

Verified By (Sign/Date)
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 40 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:
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A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
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Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

7.5 Operational Test

S. Test Acceptance Criteria Actual observations


System description
No.
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
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Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

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.
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
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Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

Different masses Result should be


ranging from consistent.
3 Accuracy Test minimum load to
maximum load area
weighed for accuracy.
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TITLE: Combined Installation/Operation Qualification Protocol of Weighing
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Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

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.

________________________________________________________________________________________________________________________________________________________________________________________________________

________________________________________________________________________________________________________________________________________________________________________________________________________
XL LABORATORIES PVT. LTD.
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TITLE: Combined Installation/Operation Qualification Protocol of Weighing
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Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

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


XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
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Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

7.6 Verification of Standard Operating Procedure:


XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
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Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

Availability Checked By Verified By


Sr. No. SOP Title
(Yes/No) (Sign/Date) (Sign/Date)
Operation & Cleaning of Weighing
1.
Balance

_______________________________________________________________________________________________________________________________________________________________________________________________________

________________________________________________________________________________________________________________________________________________________________________________________________________
XL LABORATORIES PVT. LTD.
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TITLE: Combined Installation/Operation Qualification Protocol of Weighing
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Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

Verified By (Sign/Date)
8.0 DEFICIENCY AND CORRECTIVE ACTION TAKEN

Following deficiency was identified and corrective actions taken in consultation with the
Engineering Department.
Description of deficiency:
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
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Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Corrective Action(s) Taken:
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
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Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

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.
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
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Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

10.0 COMBINED INSTALLATION/OPERATION QUALIFICATION REPORT:

Summary:
_____________________________________________________________________________
_____________________________________________________________________________
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
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Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 53 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Conclusion:
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 54 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 55 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

Compiled By: Checked By:


(Sign & Date) (Sign & Date)

11.0 LIST OF ANNEXURE:


XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 56 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

SL. NO. DETAILS OF ANNEXURES


XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 57 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 58 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 59 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

12.0 REFERENCE:
1. EudraLex Volume 4 (Annex 15: Qualification and Validation)
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 60 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

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.
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 61 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

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
Name Designation Sign/Date
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 62 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

Reviewed by : Store
Name Designation Sign/Date

Reviewed by : Quality Assurance


XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 63 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date:

Name Designation Sign/Date

Approved by : Quality Assurance


Name Designation Sign/Date
XL LABORATORIES PVT. LTD.
A-141, EPIP, RIICO Industrial Area, Neemrana, Rajasthan, India
TITLE: Combined Installation/Operation Qualification Protocol of Weighing
Page 64 of 64
Balance (Equipment ID: XL/WH/WB/01)
Document No. : XL/IOQ/WB/001 Effective Date: Review Date: