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INSTALLATION QUALIFICATION
FOR
COMPUTERIZED SYSTEM
EQUIPMENT NAME: LYOPHILIZER
EQUIPMENT ID: CPCB/PRC/LYO-01
TABLE OF CONTENT
Change History
Prepared by
Reviewed by
Approved by
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).
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
P
O
R
W
U
C
E
N
O
R
M
M
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
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
Record the equipment details like equipment name, equipment ID No., manufacturer and location.
Scope
Acceptance Criterion Physically recorded details of the equipment should match with the expected result specified in the verification table.
Done By Verified By
Sr. Pass / Discrepancy Remarks
Test Procedure Specified Observed Result (Initial/ (Initial/
No. Fail (Yes/No) (If Any)
Date) Date)
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)
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.
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
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
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
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
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
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
Make SIEMENS
Analog Input
20.
Modules 6ES7331-
Model No.
7KF02-0AA0
No. Of
2
Modules
No. Of
16
Channels
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
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
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
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
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
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.
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
To record the SCADA system configuration and software details of application installed in SCADA in the verification
Scope
table
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
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
D:\tofflon\2017-038Ca
NetSCADA 20190806
SCADA Software V1\2017 Ca NetSCADA
9.
installation path 20190806 V1\2017-
38Ca
Objective The objective of this test is to verify the power utility to the Lyophilizer.
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.
Certificate
Name of the Instrument Make Model Calibration date Calibration due date attached
(Y/N)
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
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.
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.
Certificate
Name of the Instrument Make Model Calibration date Calibration due date attached
(Y/N)
1. Temperature 0 °C – 55 °C
Objective The objective of this test is to verify the availability of documents of Lyophilizer.
Acceptance Criterion All the documents specified in the procedure should be available.
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
NA Not Applicable
DC Direct current
AC Alternating Current
IQ Installation Qualification
Abbreviations Description
SOP Standard Operating Procedure
ID Identification
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.
Prepared by
Reviewed by
Approved by