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INSTALLATION QUALIFICATION

INSTALLATION QUALIFICATION FOR COMPUTERIZED


Page 1 of 36
SYSTEM LYOPHILIZER
Protocol No.: Equipment Id.:
Effective Date
IQC/CPCB/PRC/LYO-01-00 CPCB/PRC/LYO-01

INSTALLATION QUALIFICATION
FOR
COMPUTERIZED SYSTEM
EQUIPMENT NAME: LYOPHILIZER
EQUIPMENT ID: CPCB/PRC/LYO-01

Annexure No. CP/VMP/CS/A02-00


INSTALLATION QUALIFICATION
INSTALLATION QUALIFICATION FOR COMPUTERIZED
Page 2 of 36
SYSTEM LYOPHILIZER
Protocol No.: Equipment Id.:
Effective Date
IQC/CPCB/PRC/LYO-01-00 CPCB/PRC/LYO-01

TABLE OF CONTENT

1.0 PRE APPROVAL...............................................................................................................................3


2.0 OBJECTIVE.......................................................................................................................................4
3.0 SCOPE................................................................................................................................................4
4.0 PLC SYSTEM ARCHITECTURE.....................................................................................................5
6.0 IDENTIFICATION OF EXECUTORS..............................................................................................6
7.0 PURPOSE OF INSTALLATION QUALIFICATION.......................................................................6
8.0 CONTENTS OF THE INSTALLATION QUALIFICATION...........................................................7
9.0 SUMMARY......................................................................................................................................34
10.0 CONCLUSION................................................................................................................................34
11.0 ABBREVIATIONS..........................................................................................................................34
12.0 REFERENCES.................................................................................................................................35
13.0 POST APPROVAL...........................................................................................................................36

Change History

Date Version CC Ref No. Revision summary

Annexure No. CP/VMP/CS/A02-00


INSTALLATION QUALIFICATION
INSTALLATION QUALIFICATION FOR COMPUTERIZED
Page 3 of 36
SYSTEM LYOPHILIZER
Protocol No.: Equipment Id.:
Effective Date
IQC/CPCB/PRC/LYO-01-00 CPCB/PRC/LYO-01

00 CC/PRC/19-001 New document

1.0 PRE APPROVAL


Signing of approval page of this document indicates the agreement with the Qualification approach
described in this document. If any modification approach becomes necessary, a revision through
change control shall be prepared, checked and approved. This document cannot be executed unless
approved.

Name Designation Department Signature /date

Prepared by

Reviewed by

Approved by

Annexure No. CP/VMP/CS/A02-00


INSTALLATION QUALIFICATION
INSTALLATION QUALIFICATION FOR COMPUTERIZED
Page 4 of 36
SYSTEM LYOPHILIZER
Protocol No.: Equipment Id.:
Effective Date
IQC/CPCB/PRC/LYO-01-00 CPCB/PRC/LYO-01

2.0 OBJECTIVE
The objective of this protocol is to provide a written procedure for the execution of the
Computerized System Installation Qualification (IQ) of Lyophilizer (CPCB/PRC/LYO-01).
The Computerized System of Lyophilizer (CPCB/PRC/LYO-01) has been installed in accordance
to System Requirements Specification requirements and meets the set acceptantes criteria and
cGMP requirements as stipulated in this protocol.
3.0 SCOPE
The qualification study shall be performed to the Computerized System Lyophilizer
(CPCB/PRC/LYO-01).
This protocol shall define the test procedures, documentation, references and acceptance criteria to
establish that the Computerized System Lyophilizer (CPCB/PRC/LYO-01) is installed as intended
and is in accordance to the directives from the manufacturer/supplier of the Lyophilizer
(CPCB/PRC/LYO-01).

Annexure No. CP/VMP/CS/A02-00


INSTALLATION QUALIFICATION
INSTALLATION QUALIFICATION FOR COMPUTERIZED
Page 5 of 36
SYSTEM LYOPHILIZER
Protocol No.: Equipment Id.:
Effective Date
IQC/CPCB/PRC/LYO-01-00 CPCB/PRC/LYO-01

4.0 SYSTEM ARCHITECTURE

SCADA SYSTEM
Make: DELL

24VDC PLC DI DO 1 DO 2 DO 3 DO 4 AI 1 AI 2

P
O
R
W
U
C
E
N
O
R
M
M

ES SIEMENS
SIEMENS
SIMATIC
SIMATIC
HMI
HMI

24VDC PLC DI DO AI 1 AI 2 ES SIEMENS


SIMATIC
HMI

P
O
R
W
U
C
E
N
O
R
M
M

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INSTALLATION QUALIFICATION FOR COMPUTERIZED
Page 6 of 36
SYSTEM LYOPHILIZER
Protocol No.: Equipment Id.:
Effective Date
IQC/CPCB/PRC/LYO-01-00 CPCB/PRC/LYO-01

5.0 RESPONSIBILITIES
The group comprising of representatives from each of the following departments shown in the
table below and they shall be responsible for the overall compliance with this protocol.

Department Responsibility

Shall be trained on protocol methodology.


User
Support for the execution of the study.
Department
Review of the Protocol and summary.

Shall be trained on protocol methodology.


Engineering
Support for the execution of the study.
Department
Review of the Protocol and summary.

Preparation of the protocol.


Providing training on execution of the Study.
QA-CSV
Execution of the study/ verification.
Closure of the study and necessary discrepancy (if any) handling.

Review and approval of the Protocol.


QA Department Monitoring of the Execution.
Review and approval of the Summary report.
6.0 IDENTIFICATION OF EXECUTORS
PERSON INVOLVED IN THE EXECUTION OF THE PROTOCOL SHALL BE TRAINED ON
THE CONCEPT OF VALIDATION

S. No Name Of The Executor Department & Designation Sign & Date

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Page 7 of 36
SYSTEM LYOPHILIZER
Protocol No.: Equipment Id.:
Effective Date
IQC/CPCB/PRC/LYO-01-00 CPCB/PRC/LYO-01

S. No Name Of The Executor Department & Designation Sign & Date

Verified by ( QA):
7.0 PURPOSE OF THE INSTALLATION QUALIFICATION
The installation qualification protocol of Lyophilizer (CPCB/PRC/LYO-01). Provide the
documented verification that all key aspects of the Lyophilizer (CPCB/PRC/LYO-01) installation
(applied components, settings, software and specifications) adhere to the specified design and is
installed according to the customary regulations and recommendations. Execution of the approved
installation qualification protocol shall be carried out by trained and qualified personnel.
8.0 CONTENTS OF THE INSTALLATION QUALIFICATION
Installation tests to be performed as part of this validation effort are listed below. Specific test
procedure as well as acceptance criteria are defined in the individual test scripts. The result of the
installation tests shall be documented in the appropriate test scripts during execution.
 Test ID/Description: IQ 1 / Verification of equipment details
The objective of this test is to verify and record the details of the installed equipment.
 Test ID/Description: IQ 2 / Verification of hardware components
The objective of this test is to verify and record the details of the hardware components.
 Test ID/Description: IQ 3 / Verification of software details
The objective of this test is to verify and record the details of the installed software and the
availability of software backup.
 Test ID/ Description: IQ 4 / Verification of SCADA System Configuration and Software
Installation
The objective of this test is to verify SCADA system configuration and the installation of
SCADA software
 Test ID/Description: IQ 5 / Verification of user access levels
The objective of this test is to verify and record the user access levels.
 Test ID/Description: IQ 6 / Verification of power utility
The objective of this test is to verify and record the power utility of the installed equipment.
Annexure No. CP/VMP/CS/A02-00
INSTALLATION QUALIFICATION
INSTALLATION QUALIFICATION FOR COMPUTERIZED
Page 8 of 36
SYSTEM LYOPHILIZER
Protocol No.: Equipment Id.:
Effective Date
IQC/CPCB/PRC/LYO-01-00 CPCB/PRC/LYO-01
 Test ID/ Description: IQ 7 / Verification of environmental conditions
The objective of this test is to verify and record the environmental conditions of the installed
equipment.
 Test ID/ Description: IQ 8 / Verification of documents
The objective of this test is to verify and record the availability of relevant documents

Annexure No. CP/VMP/CS/A02-00


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Protocol No.: IQC/CPCB/PRC/LYO-01-00 Equipment Id.: CPCB/PRC/LYO-01 Effective Date

TEST IQ 1: VERIFICATION OF EQUIPMENT DETAILS


Objective The objective of this test is to verify the equipment details.

Record the equipment details like equipment name, equipment ID No., manufacturer and location.
Scope

Record the following details of installed equipment:


 Equipment Name - Equipment Name Plate
Procedure  Equipment ID No. - Equipment Tag Plate
 Manufacturer - The manufacturer of the Equipment
 Location - Location of the room

Acceptance Criterion Physically recorded details of the equipment should match with the expected result specified in the verification table.

Attachment No: _____

Annexure No. CP/VMP/CS/A02-00


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Protocol No.: IQC/CPCB/PRC/LYO-01-00 Equipment Id.: CPCB/PRC/LYO-01 Effective Date

Verification table for equipment details

Done By Verified By
Sr. Pass / Discrepancy Remarks
Test Procedure Specified Observed Result (Initial/ (Initial/
No. Fail (Yes/No) (If Any)
Date) Date)

1. Equipment Name Lyophilizer

2. Equipment ID CPCB/PRC/LYO-01

Shanghai Tofflon
Science &
3. Manufacturer
Technology Co.,
Ltd.
Cephalosporin
Block
Production
4. Location Injectable
Lyo Servicing Area
Area
(CBGF-33)

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Protocol No.: IQC/CPCB/PRC/LYO-01-00 Equipment Id.: CPCB/PRC/LYO-01 Effective Date

TEST IQ 2: VERIFICATION OF HARDWARE COMPONENTS

Objective The objective of this test is to verify the details hardware components of Lyophilizer .
Scope Record the observed details of hardware components in verification table.
Physically observe the details such as make, model, type and serial number (as applicable), of the following hardware
components:
 PLC
 HMI
Procedure  Input and output modules (Digital and analog)
 Ethernet Switch
 SCADA
 Communication cable between PLC and HMI
 Communication cable between PLC and SCADA
Record the observations in the test data table below.
Acceptance Criterion Observed details of the hardware components should match with the expected result specified in the verification table.

Attachment No: _____

Verification table for hardware components

Annexure No. CP/VMP/CS/A02-00


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Protocol No.: IQC/CPCB/PRC/LYO-01-00 Equipment Id.: CPCB/PRC/LYO-01 Effective Date

Done By Verified By
Sr. Observed Pass Discrepancy Remarks
Test Procedure Specified (Initial/ (Initial/
No. Result / Fail (Yes/No) (If Any)
Date) Date)
LYOPHILIZER (SIP,CIP)

Make DELL
1. SCADA
Model No. OptiPlex3040

Make SIEMENS
2. PLC
315-2EH13-
Model No.
0AB0

Make SIEMENS
3. HMI-1
6AV2 124-
Model No.
0JC01-0AX0

Make SIEMENS
4. HMI-2
6AV2 124-
Model No.
0GC01-0AX0
5. Make SIEMENS

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Protocol No.: IQC/CPCB/PRC/LYO-01-00 Equipment Id.: CPCB/PRC/LYO-01 Effective Date

Done By Verified By
Sr. Observed Pass Discrepancy Remarks
Test Procedure Specified (Initial/ (Initial/
No. Result / Fail (Yes/No) (If Any)
Date) Date)
6ES7321-
Model No.
Digital Input 1BP00-0AA0
Module No. Of Digital
64
Inputs
Make SIEMENS

Digital Output 6ES7322-


6. Model No.
Module 1 1BL00-0AA0
No. Of Digital
32
Outputs
Make SIEMENS

Digital Output 6ES7322-


7. Model No.
Module 2 1BL00-0AA0
No. Of Digital
32
Outputs
8. Make SIEMENS

Annexure No. CP/VMP/CS/A02-00


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Protocol No.: IQC/CPCB/PRC/LYO-01-00 Equipment Id.: CPCB/PRC/LYO-01 Effective Date

Done By Verified By
Sr. Observed Pass Discrepancy Remarks
Test Procedure Specified (Initial/ (Initial/
No. Result / Fail (Yes/No) (If Any)
Date) Date)
6ES7322-
Model No.
Digital Output 1BL00-0AA0
Module 3 No. Of Digital
16
Outputs
Make SIEMENS

Digital Output 6ES7322-


9. Model No.
Module 4 1BL00-0AA0
No. Of Digital
16
Outputs
Make SIEMENS

Analog Input 6ES7331-


10. Model No.
Module 1 7KF02-0AA0
No. Of
8
Channels
11. Make SIEMENS

Annexure No. CP/VMP/CS/A02-00


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Protocol No.: IQC/CPCB/PRC/LYO-01-00 Equipment Id.: CPCB/PRC/LYO-01 Effective Date

Done By Verified By
Sr. Observed Pass Discrepancy Remarks
Test Procedure Specified (Initial/ (Initial/
No. Result / Fail (Yes/No) (If Any)
Date) Date)
6ES7331-
Model No.
Analog Input 7KF02-0AA0
Module 2 No. Of
8
Channels

Make M0XA
12. Ethernet Switch
Model No. EDS-205A

Communication
13. cable between PLC Type Profinet
and HMI 1
Communication
14. cable between PLC Type Profinet
and HMI 2
Communication
RJ - 45 Ethernet
cable between PLC
15. Type Communication
and SCADA
Cable
System

Annexure No. CP/VMP/CS/A02-00


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Protocol No.: IQC/CPCB/PRC/LYO-01-00 Equipment Id.: CPCB/PRC/LYO-01 Effective Date

Done By Verified By
Sr. Observed Pass Discrepancy Remarks
Test Procedure Specified (Initial/ (Initial/
No. Result / Fail (Yes/No) (If Any)
Date) Date)
CIP SYTEM

Make SIEMENS
16. HMI
6AV2 124-
Model No.
0GC01-0AX0

Make SIEMENS
17. PLC
6ES7315-
Model No.
2EH14-0AB0

Make SIEMENS
Digital Input
18.
Module 6ES7321-
Model No.
1BH02-0AA0

Annexure No. CP/VMP/CS/A02-00


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Protocol No.: IQC/CPCB/PRC/LYO-01-00 Equipment Id.: CPCB/PRC/LYO-01 Effective Date

Done By Verified By
Sr. Observed Pass Discrepancy Remarks
Test Procedure Specified (Initial/ (Initial/
No. Result / Fail (Yes/No) (If Any)
Date) Date)
No.Of Digital
16
Inputs

Make SIEMENS

Digital Output 6ES7322-


19. Model No.
Module 1BL00-0AA0
No. Of Digital
32
Outputs

Make SIEMENS
Analog Input
20.
Modules 6ES7331-
Model No.
7KF02-0AA0
No. Of
2
Modules
No. Of
16
Channels

Annexure No. CP/VMP/CS/A02-00


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Protocol No.: IQC/CPCB/PRC/LYO-01-00 Equipment Id.: CPCB/PRC/LYO-01 Effective Date

Done By Verified By
Sr. Observed Pass Discrepancy Remarks
Test Procedure Specified (Initial/ (Initial/
No. Result / Fail (Yes/No) (If Any)
Date) Date)
Communication
21. cable between PLC Type Profinet
and HMI

TEST IQ 3: VERIFICATION OF SOFTWARE DETAILS


Objective The objective of this test is to verify the software details.
Scope Record the details of PLC and HMI/SCADA software in verification table

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Protocol No.: IQC/CPCB/PRC/LYO-01-00 Equipment Id.: CPCB/PRC/LYO-01 Effective Date

Physically observe and record the following details of the software installed in the Lyophilizer:
 PLC
 Name of the software
Procedure  Version Number
 HMI And SCADA
 Name of the software
 Version Number

Record the observations in verification table.


 Observed details of the installed software in the Lyophilizer should match with the expected result specified in
Acceptance Criterion
verification table

Attachment No: ____


Verification table for software details

Done By Verified By
Sr. Pass / Discrepancy Remarks
Software Expected Result Actual Result (Initial/ (Initial/
No. Fail (Yes/No) (If Any)
Date) Date)

Name of the
PLC 1 STEP7
1. software

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Protocol No.: IQC/CPCB/PRC/LYO-01-00 Equipment Id.: CPCB/PRC/LYO-01 Effective Date

Done By Verified By
Sr. Pass / Discrepancy Remarks
Software Expected Result Actual Result (Initial/ (Initial/
No. Fail (Yes/No) (If Any)
Date) Date)

Version
V5.5
Number

Name of the
STEP7
software
2. PLC 2
Version
V5.5
Number

Name of the
software TIA
3. HMI-1
Version
Number V13.00

Name of the
software TIA

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Protocol No.: IQC/CPCB/PRC/LYO-01-00 Equipment Id.: CPCB/PRC/LYO-01 Effective Date

Done By Verified By
Sr. Pass / Discrepancy Remarks
Software Expected Result Actual Result (Initial/ (Initial/
No. Fail (Yes/No) (If Any)
Date) Date)
4. HMI-2 Version
13.00
Number

Name of the
software TIA
5. HMI-3
Version
V13.00
Number

Name of the NETSCADA


software FIELD
SCADA
6.
Version
V5.0
Number

TEST IQ 4: VERIFICATION OF USER ACCESS LEVELS


Objective The objective of this test is to verify the security configuration in the Lyophilizer.

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Protocol No.: IQC/CPCB/PRC/LYO-01-00 Equipment Id.: CPCB/PRC/LYO-01 Effective Date

Scope Record the user access levels in the verification table

Physically verify the following details of user access levels:

Procedure  Number of access levels


 Auto log off time
Record the observations in the verification table.
Acceptance Criterion Observed result should match with the expected result mentioned in the verification table.

Attachment No: _____

Verification of user access levels

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Protocol No.: IQC/CPCB/PRC/LYO-01-00 Equipment Id.: CPCB/PRC/LYO-01 Effective Date

Done By Verified By
Sr. Pass / Discrepancy Remarks
Test Procedure Specified Observed Result (Initial/ (Initial/
No. Fail (Yes/No) (If Any)
Date) Date)
FOR SCADA
Verify the system There should be
1. logical security. different levels of
Note down the levels security access
of security access available in the system.
available in the Operator Level:
system Logical Security
Available: Yes / No
Supervisor Level:
Logical Security
Available: Yes / No
Admin Level:
Logical Security
Available: Yes / No
Verify the system
2. 5 minutes
auto log off time.

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Protocol No.: IQC/CPCB/PRC/LYO-01-00 Equipment Id.: CPCB/PRC/LYO-01 Effective Date

Done By Verified By
Sr. Pass / Discrepancy Remarks
Test Procedure Specified Observed Result (Initial/ (Initial/
No. Fail (Yes/No) (If Any)
Date) Date)
FOR HMI
Verify the system
logical security. There should be only
Note down the levels one level of security
3.
of security access access available in the
available in the HMI.
system

TEST IQ 5: VERIFICATION OF SCADA SYSTEM CONFIGURATION AND SOFTWARE INSTALLATION


Objective The objective of this test is to verify SCADA system configuration and installation of application software in SCADA.

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Protocol No.: IQC/CPCB/PRC/LYO-01-00 Equipment Id.: CPCB/PRC/LYO-01 Effective Date

To record the SCADA system configuration and software details of application installed in SCADA in the verification
Scope
table

 Physically observe the make and model of the SCADA system.


 Turn on the power to the SCADA System.
 Click on “Start” icon in the task bar.
 From the start menu, right click on “My Computer” and select “properties” to record the below configuration details:
Procedure  Manufacturer, Computer Processor, Operating System RAM, Keyboard, Product ID.
 Verify the following details of the installed application software in SCADA:
 Name of the application software
 Version number of the application software
 Installation path of the application software.
Observed details of the SCADA system configuration should match with the specifications mentioned in the verification
Acceptance Criteria
table.

Annexure No: ____

Verification table for SCADA System Configuration and software installation

Annexure No. CP/VMP/CS/A02-00


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Protocol No.: IQC/CPCB/PRC/LYO-01-00 Equipment Id.: CPCB/PRC/LYO-01 Effective Date

Done By Verified By
Sr. Pass / Discrepancy Remarks
Test Procedure Specified Observed Result (Initial/ (Initial/
No. Fail (Yes/No) (If Any)
Date) Date)
SCADA SYSTEM CONFIGURATION

1. Manufacturer Dell

Intel(R) Pentium(R)
2. Computer Processor CPU G3240 @ 3.10GHz
3.10 GHz
Windows 7 professional
3. Operating System
32-bit

4. RAM 2.00 GB

5. Keyboard Standard

00426-OEM-8992662-
6. Product ID
00006

SOFTWARE INSTALLATION

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Protocol No.: IQC/CPCB/PRC/LYO-01-00 Equipment Id.: CPCB/PRC/LYO-01 Effective Date

Done By Verified By
Sr. Pass / Discrepancy Remarks
Test Procedure Specified Observed Result (Initial/ (Initial/
No. Fail (Yes/No) (If Any)
Date) Date)
Name of SCADA
7. Application NETSCADA FIELD
software

8. Version number V5.0

D:\tofflon\2017-038Ca
NetSCADA 20190806
SCADA Software V1\2017 Ca NetSCADA
9.
installation path 20190806 V1\2017-
38Ca

TEST IQ 6: VERIFICATION OF POWER UTILITY

Annexure No. CP/VMP/CS/A02-00


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Protocol No.: IQC/CPCB/PRC/LYO-01-00 Equipment Id.: CPCB/PRC/LYO-01 Effective Date

Objective The objective of this test is to verify the power utility to the Lyophilizer.

Scope Record the observed power utility in verification table 2.

Tools required Calibrated digital multimeter

 Verify the calibration status of the digital multimeter and record the same in verification table 1.
 Turn on the power to the Lyophilizer. Set the multimeter in DC voltage measurement range and measure the voltage at
Procedure PLC terminal end. Note down the voltage reading in verification table 2.
 Set the multimeter in DC voltage measurement range and measure the voltage at HMI And SCADA terminal end.
Note down the voltage reading in verification table 2.

Acceptance Criterion Recorded measurements of power utility should be within the specified range.

Attachment No: ____

Verification Table 1: Verification of calibration status

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Protocol No.: IQC/CPCB/PRC/LYO-01-00 Equipment Id.: CPCB/PRC/LYO-01 Effective Date

Certificate
Name of the Instrument Make Model Calibration date Calibration due date attached
(Y/N)

Verification Table 2: Verification of power utility

Done By Verified By
Sr. Pass / Remarks
Procedure Expected Result Actual Result Discrepancy (Initial/ (Initial/
No.
Sr. Procedure Expected Result Actual Result Fail /
Pass Discrepancy (If Any)
Remarks Done By Verified By
Date) Date)
No. Fail (If Any) (Initial/ (Initial/
CIP SYSTEM Date) Date)
LYOPHILIZER (SIP,CIP)
Voltage at PLC
1.
3. Voltage 20
20 -- 30
30 VDC
terminalatend
HMI 1 VDC
terminal end
4. Voltage at HMI 2 20 - 30 VDC
2. terminal end 20 - 30 VDC

5. Voltage at PLC 20 - 30 VDC


terminal end
Voltage at SCADA
6. 230 VAC
terminal end
Annexure No. CP/VMP/CS/A02-00
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Protocol No.: IQC/CPCB/PRC/LYO-01-00 Equipment Id.: CPCB/PRC/LYO-01 Effective Date

TEST IQ 7: VERIFICATION OF ENVIRONMENTAL CONDITIONS

Objective The objective of this test is to verify the environmental conditions for Lyophilizer

Scope Record the observed Temperature and Relative Humidity values in verification table 2.

Tools Required Calibrated Thermo Hygrometer/Equivalent instrument

 Verify the calibration status of the Thermo Hygrometer/Equivalent instrument and record the same in verification table 1.
Procedure  Place the thermo hygrometer near the Lyophilizer and observe the temperature and relative humidity values.
 Record all the observations in verification table 2.

The observed values of environmental conditions should be:


Acceptance
Criterion - Temperature: less than 55 °C
- Relative Humidity: less than 90%

Attachment No: ____

Annexure No. CP/VMP/CS/A02-00


INSTALLATION QUALIFICATION
INSTALLATION QUALIFICATION FOR COMPUTERIZED SYSTEM LYOPHILIZER Page 31 of 36

Protocol No.: IQC/CPCB/PRC/LYO-01-00 Equipment Id.: CPCB/PRC/LYO-01 Effective Date

Verification Table 1: Verification of calibration status

Certificate
Name of the Instrument Make Model Calibration date Calibration due date attached
(Y/N)

Verification Table 2: Verification of environmental conditions


Done By
Sr. Pass / Discrepancy Remarks Verified By
Test Procedure Specified Observed Result (Initial/
No. Fail (Yes/No) (If Any) (Initial/ Date)
Date)

1. Temperature 0 °C – 55 °C

2. Relative Humidity < 90% RH

Annexure No. CP/VMP/CS/A02-00


INSTALLATION QUALIFICATION
INSTALLATION QUALIFICATION FOR COMPUTERIZED SYSTEM LYOPHILIZER Page 32 of 36

Protocol No.: IQC/CPCB/PRC/LYO-01-00 Equipment Id.: CPCB/PRC/LYO-01 Effective Date

TEST IQ 8: VERIFICATION OF DOCUMENTS

Objective The objective of this test is to verify the availability of documents of Lyophilizer.

Scope Record the availability of documents of Lyophilizer in verification table

 Check for the availability of the following documents:


Operational manual
Procedure Wiring diagram
P & ID
 Document the availability of documents in the verification table below.

Acceptance Criterion All the documents specified in the procedure should be available.

Attachment No: ____

Annexure No. CP/VMP/CS/A02-00


INSTALLATION QUALIFICATION
INSTALLATION QUALIFICATION FOR COMPUTERIZED SYSTEM LYOPHILIZER Page 33 of 36

Protocol No.: IQC/CPCB/PRC/LYO-01-00 Equipment Id.: CPCB/PRC/LYO-01 Effective Date

Verification table for documents availability

Done By
Sr. Test Pass / Discrepancy Remarks Verified By
Specified Observed Result (Initial/
No. Procedure Fail (Yes/No) (If Any) (Initial/Date)
Date)
Operational Operational manual
1.
manual should be available
PLC wiring
PLC wiring
2. diagram should be
diagram
available
P & ID diagram
3. P & ID
should be available

Annexure No. CP/VMP/CS/A02-00


INSTALLATION QUALIFICATION
INSTALLATION QUALIFICATION FOR COMPUTERIZED
Page 34 of 36
SYSTEM LYOPHILIZER
Protocol No.: Equipment Id.:
Effective Date
IQC/CPCB/PRC/LYO-01-00 CPCB/PRC/LYO-01
9.0 SUMMARY
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
10.0 CONCLUSION
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
11.0 ABBREVIATIONS
Abbreviations Description

PLC Programmable Logic Controller

HMI Human Machine Interface

SCADA Supervisory Control And Data Acquisition

NA Not Applicable

DC Direct current

AC Alternating Current

IQ Installation Qualification

LED Light Emitting Diode

Annexure No. CP/VMP/CS/A02-00


INSTALLATION QUALIFICATION
INSTALLATION QUALIFICATION FOR COMPUTERIZED
Page 35 of 36
SYSTEM LYOPHILIZER
Protocol No.: Equipment Id.:
Effective Date
IQC/CPCB/PRC/LYO-01-00 CPCB/PRC/LYO-01

Abbreviations Description
SOP Standard Operating Procedure

ID Identification

cGMP Current Good Manufacturing Practices

GAMP Good Automated Manufacturing Practices

GMP Good Manufacturing Practices

V Volts

DI Digital Input

DO Digital Output

AI Analog Input

AO Analog Output

ES Ethernet Switch

12.0 REFERENCES
a. User Requirement Specification.
b. Qualification Documents.
c. System Operation Manual (Lyophilizer).
d. Computerized System Validation Master Plan (CP/VMP/CS-01).
e. GAMP 5 Categorization.

Annexure No. CP/VMP/CS/A02-00


INSTALLATION QUALIFICATION
INSTALLATION QUALIFICATION FOR COMPUTERIZED
Page 36 of 36
SYSTEM LYOPHILIZER
Protocol No.: Equipment Id.:
Effective Date
IQC/CPCB/PRC/LYO-01-00 CPCB/PRC/LYO-01
13.0 POST APPROVAL:
Signing of Report page of this document indicates the acceptance of Installation
Qualification approach described in this document.

Name Designation Department Signature/date

Prepared by

Reviewed by

Approved by

Annexure No. CP/VMP/CS/A02-00

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