HH-4299.044-OQ-MDPI Checkweigher-00 - V1 - 0 - Eng

Operational Qualification
(OQ)
Test Protocol
Machine type: MDPI Checkweigher

Machine no.: HH-4299.044
Project: MDPI Checkweigher / DBL
Pharmaceuticals Ltd.
Operational Qualification (OQ) Page
Test Protocol 1 / 49

DBL Pharmaceuticals Ltd. Version 1.0
Pre-Approval
The following signatures confirm the approval of the OQ Test Protocol for performance.
Harro Höfliger
Created by Birsen Öztürk 07 Mar '23

Validation Services Date Signature
Reviewed by
Approved by
DBL Pharmaceuticals Ltd.
Reviewed by
Validation Date Signature
Approved by
Engineering Date Signature
Post-Approval by DBL Pharmaceuticals Ltd.

The following signatures confirm that the OQ Test Protocol has been completed.
Reviewed by
Production Date Signature
Reviewed by
Quality Assurance (QA) Date Signature
Approved by
Quality Operations (QO) Date Signature
Doc-ID: HH-4299.044-OQ-MDPI Checkweigher-00


Table of contents
1 Version history ......................................................................................................................... 3
2 Abbreviations ........................................................................................................................... 4
2.1 General ......................................................................................................................................................... 4
2.2 Project specific ............................................................................................................................................ 4
2.3 Units.............................................................................................................................................................. 4
3 Reference documents .............................................................................................................. 5
4 Purpose..................................................................................................................................... 5
5 Equipment ................................................................................................................................ 5
5.1 Project data .................................................................................................................................................. 5
5.2 Equipment data ........................................................................................................................................... 5
6 Numbering of tests................................................................................................................... 5
7 Auxiliaries for test performance.............................................................................................. 6
8 Deviation handling ................................................................................................................... 6
9 Signature list ............................................................................................................................ 7

9.1 HH team ........................................................................................................................................................ 7
9.2 DBL Pharmaceuticals Ltd. team ................................................................................................................ 7
10 Formats, materials and products ............................................................................................ 8
11 General machine set-up ........................................................................................................... 9
12 Date and time verification on HMI ........................................................................................... 9
13 Attachments ........................................................................................................................... 10
14 HH standard tests: Operational Tests (OT) .......................................................................... 11

14.1 OT1000-00 [QMP] - IQ deviations ............................................................................................................. 11
14.2 OT1000-01A [QMP] - Emergency Stop .................................................................................................... 13
14.3 OT1000-02A [QMP] - Guard doors locked .............................................................................................. 15
15 HH standard tests: Computer System Validation - Operational Tests (CSV-OT) ............... 18

15.1 CSV-OT1000-01 [QMP] - Data storage after power failure .................................................................... 18
15.2 CSV-OT1000-03 [QMP] - User and password management .................................................................. 21
15.3 CSV-OT1000-04 [QMP] - HMI reporting - function .................................................................................. 27
15.4 CSV-OT1000-06 [QMP] - Disaster recovery ............................................................................................ 36
15.5 CSV-OT1000-08 [QMP] - HMI reporting - content ................................................................................... 39
16 pFMEA tests ........................................................................................................................... 42

16.1 OT1100-01 [FMEA-CT] - Function of weighing cells .............................................................................. 42
16.2 OT1100-02 [FMEA-CT] - Weight accuracy of weighing cell .................................................................. 44
16.3 OT1110-01 [FMEA-CT] - Function of weighing receptacle lifting unit ................................................. 47
17 Release for next qualification phase..................................................................................... 49


1 Version history
Version Date Creator Description
0.1 03 Mar '23 Birsen Öztürk Draft Version
1.0 07 Mar '23 Birsen Öztürk Final Version


2 Abbreviations
2.1 General
Commonly used abbreviations (e.g., etc., i.e., incl., no., 3D, CAD, PDF, RTF, MS, Inc., …) are not documented.
All other abbreviations used in this document (including all related attachments) are listed below.
Abbreviation Explanation
Att Attachment
CSV Computer System Validation
Doc Document
FDS Functional Design Specification
FMEA-CD FMEA-Cause Detection
FMEA-CT FMEA-Challenge Test
GMP Good Manufacturing Practice
HH Harro Höfliger Verpackungsmaschinen GmbH
hh:mm Time format for hours:minutes
HMI Human Machine Interface
ID Identification
n.a. Not applicable
OQ Operational Qualification
OT Operational Test
pFMEA Process Failure Mode and Effects Analysis
PLC Programmable Logic Controller
QMP Qualification Master Plan
SDS Software Design Specification
URS User Requirements Specification
2.2 Project specific

Project specific abbreviations used in this document (including all related attachments) are listed below.
MDPI Checkweigher Multi dose Dry Powder Inhaler Checkweigher (machine type)
2.3 Units
Abbreviations used for units in this document (including all related attachments) are listed below.
mg Milligram
Cg Refer to the ration between precision and tolerance (the potential capability)
CgK denotes to the ration between accuracy and tolerance (the actual capability)


3 Reference documents
Further information for the project will be described in the documents (including all related attachments) listed
below. In addition, these documents were used to create this test protocol.
Document Doc-ID
User Requirements Specification (URS) URS/OEMFM/PRD/0159/01 /
URS/OEMFM/PRD/0159/02
Supplier Response Matrix (SRM) 109286-SRM-MDPI Checkweigher-00
Qualification Master Plan (QMP) 109286-QMP-MDPI Checkweigher-00
Functional Design Specification (FDS) HH-4299.044-FDS-MDPI Checkweigher-00
Software Design Specification (SDS) HH-4299.044-SDS-MDPI Checkweigher-00
Process Failure Mode and Effects Analysis (pFMEA) HH-4299.044-pFMEA-MDPI Checkweigher-00
4 Purpose
The purpose of the Operational Qualification (OQ) is to perform a documented verification of the equipment as
installed to ensure that the equipment is functioning in accordance to the specification.
5 Equipment
This document is valid for the following project / equipment as listed below.
5.1 Project data

Project no. 109286
Project name MDPI Checkweigher / DBL Pharmaceuticals Ltd.
5.2 Equipment data

Order no. 30892
Machine no. HH-4299.044
Machine type Multi dose Dry Powder Inhaler Checkweigher
6 Numbering of tests
The numbering of the tests is defined in the Qualification Master Plan and Process Failure Mode and Effects
Analysis - Attachment 1.
Depending on the scope of testing (as defined in the QMP) tests may be omitted and therefore the numbering of
the tests is not consecutive.


7 Auxiliaries for test performance

For test performance the following auxiliaries are needed
• Writing instrument with waterproof permanent blue ink
• Permanent marker (for marking bad product)
• Ruler
• Key for machine guarding
• Key for control cabinet
All other auxiliaries are listed in the respective test under "Test pre-condition".
8 Deviation handling
All observed deviations are classified in a Deviation Assessment of the Deviation Report by the following evaluation
criteria.
Classification Explanation
Deviations that stop the further execution of the current qualification phase.
Risk of complete functional loss of the product due to

• Product damage / malfunction / contamination
Critical • Equipment damage
• Specifications not approved
• Mismatch of counters
• Mismatch of reject function
• Audit trail / batch report incorrect
Deviations that require correction before starting the next qualification phase.
Potential functional loss of the product due to

Major • Function not as specified
• Component not as specified
• Incorrect electrical / mechanical / pneumatic installation
• Wrong material for product contacting parts
Deviations that require correction before starting the production.
No functional loss of the product. No effect on the product quality due to

Minor • Documentation error
• Documentation not complete
• Component labeling missing / wrong
• Cosmetic damages


9 Signature list
All persons performing the tests and / or adding any comment to this test protocol must be listed in the table below.
The people who are performing the tests confirm with their signature that they are
• Familiar with the equipment functionality
9.1 HH team
Name Department Initials Signature
(legibly and in block letters)
9.2 DBL Pharmaceuticals Ltd. team

Name Department Initials Signature
(legibly and in block letters)


10 Formats, materials and products

In the following table all materials / products used during the test performance must be listed.
Format Material / product Batch no. Initials Date


11 General machine set-up

Prior performing of operational tests (OT / CSV-OT) ensure that
• The login on HMI is done with user access level that enables access to all required machine functions
• Machine is prepared for production (material / product available as listed in "chapter 10 formats, materials and
products” of this test protocol)
• A valid format is loaded and active on HMI
• Valid machine parameters are loaded on HMI
• Machine is set-up according to current machine setting list
• Machine status: fault free, referenced, stopped in home position, automatic mode is selected
12 Date and time verification on HMI

Prior performing the first test the current date and time displayed on HMI must be verified.
If an incorrect date / time is observed on HMI, the date / time must be corrected.
Once the date / time has been set on the HMI, it must not be changed until all tests in this test protocol have been
completed.
On HMI the
• Date
• Time
is set as listed below.
HMI date Current date HMI time (hh:mm) Current time (hh:mm)
Verified by
(date / signature)


13 Attachments
Attachment no. Document / Attachment Doc-ID / Total number of pages
1 OQ Attachment 1 - Deviation Report HH-4299.044-OQ-MDPI Checkweigher-01
2 Att-OT-14.1, no. 2
3 Att-CSV-OT-15.2, no. 10
4 Att-CSV-OT-15.3, no. 22
5 Att-CSV-OT-15.3 no. 14
11 Att-OT-16.2, no. 4
12 Att-OT-16.3, no. 2

14 HH standard tests: Operational Tests (OT)

14.1 OT1000-00 [QMP] - IQ deviations
Objective Acceptance criterion
The objective of this test is to verify the • All deviations are closed and approved which are scheduled with closing date
• Deviations latest start of OQ
observed during performance of IQ.
Further acceptance criteria, which are not directly related to the test objective, are
only listed in the test.
Test pre-condition Comment / Attachment
• Deviation Report of the IQ • Att-OT-14.1, no. 2, total no. of pages ____
Test result (to be filled in by reviewer) Reviewed by (date / signature)
Passed Failed, see deviation no. _____

OT1000-00 [QMP] - IQ deviations

No. Description Acceptance criterion Fulfilled? Date / initials
IQ deviations
□ □
Verify status of the deviations observed during IQ against All deviations are closed and approved which are scheduled
Deviation Report (Doc-ID: HH-4299.044-IQ-Deviation with closing date latest start of OQ.
Report_MDPI Checkweigher-01).
Yes No
□ □
Tick-off checked items in Deviation Report. Pages are attached to this test protocol.
Attach the pages to this test protocol.
Yes No
End of test

14.2 OT1000-01A [QMP] - Emergency Stop

The objective of this test is to verify the • Machine stops as soon as Emergency Stop button is activated with fault number
• Machine behavior in case of Emergency Stop button activation. • Fault cannot be reset
• Machine cannot be started
• See “chapter 11 general machine set-up” in this test protocol

OT1000-01A [QMP] - Emergency Stop

Emergency Stop button activation
□ □
Press start. Machine is running.
Press Emergency Stop button at Machine stops as soon as Emergency Stop button is activated
• Operating Panel (E-Stop 1A06-1S1). with fault number: [50]
Yes No
□ □
Press reset. Fault cannot be reset.
Yes No
□ □
Press start. Machine cannot be started.
Yes No
□ □
Check machine for misplaced products. No machine error caused by previous simulation.
Release Emergency Stop button.
Yes No
HMI reporting
□ □
Verify alarm history and record event time. Fault number caused by previous simulation listed in alarm
history with event time as recorded below:
Yes No
• ______ : ______ (hh:mm)
End of test

14.3 OT1000-02A [QMP] - Guard doors locked

The objective of this test is to verify the • Guard doors cannot be opened during machine operation
• Guard door function. • Guard doors can be opened during machine standstill
• Display of fault number
• Fault cannot be reset
• Machine cannot be started

OT1000-02A [QMP] - Guard doors locked

Guard door function during machine operation
□ □
Press start. Machine is running.
Yes No
□ □
Attempt to open guard doors at: Guard doors cannot be opened.
• Guard door 1 (guard door / 1A06-1S2)
Yes No
□ □
Press stop. Machine stops.
Yes No
Guard door function during machine standstill
□ □
Open guard door at Guard door can be opened with display of fault number: [50]
• Guard door 1 (guard door / 1A06-1S2)
Yes No
□ □
Press reset. Fault cannot be reset.
Yes No
□ □
Press start. Machine cannot be started.
Yes No

OT1000-02A [QMP] - Guard doors locked

□ □
Close guard door and press reset. No machine error caused by previous simulation.
Yes No
HMI reporting
□ □
Verify alarm history and record event time. Fault number caused by previous simulation is listed in alarm
history with event time as recorded below:
Yes No
• ______ : ______ (hh:mm
End of test

15 HH standard tests: Computer System Validation - Operational Tests (CSV-OT)

15.1 CSV-OT1000-01 [QMP] - Data storage after power failure
The objective of this test is to verify the • Measurement report is still active after power failure
• Data storage in case of power failure. • GMP-critical HMI parameter have not been changed and comply with the
recorded values before power failure
• Filled blister strip

CSV-OT1000-01 [QMP] - Data storage after power failure

Count of total good and bad part counters
□ □
Start a measurement. Measurement is started.
Yes No
□ □
Change three critical HMI parameters. Critical HMI parameters are changed as recorded below:
Record the changes.
• _____________________ __________ __________
Yes No
Parameter 1 Old value New value
• _____________________ __________ __________

• _____________________ __________ __________

□ □
Run the machine. Machine is running.
Yes No
□ □
Simulate a power failure by switching off the machine at its Power failure is simulated and all computers / systems are shut
main switch. down.
Yes No
□ □
Switch on the machine at its main switch. All computers / systems are booting and HMI starts without any
operator intervention.
Yes No

CSV-OT1000-01 [QMP] - Data storage after power failure

□ □
Verify user log in. No user is logged in.
Yes No
□ □
Verify measurement status. Measurement is still active.
Yes No
□ □
Verify changed critical HMI parameter. Critical HMI parameter have not been changed and comply with
the recorded values before power failure.
Yes No
□ □
Set machine back to original condition. No machine error caused by previous simulation.
Yes No
HMI reporting
□ □
Verify audit trail and record event time. Changed items caused by previous simulation are listed in audit
trail with event time as recorded below:
Yes No
• ______ : ______ (hh:mm) to ______ : ______ (hh:mm)
End of test

15.2 CSV-OT1000-03 [QMP] - User and password management

The objective of this test is to verify the • User and password management comply with the specified requirements in the
• User and password management. Software Design Specification (SDS)
• See “chapter 11 general machine set-up” in this test protocol • Att-CSV-OT-15.2, no. 22, total no. of pages ____ Att.-No.: ______
• Technical Documentation>Additional System Documents>
• SDS
• Operating manual

CSV-OT1000-03 [QMP] - User and password management

User management
□ □
Verify actual user groups against SDS. All user groups are available and assigned to their
(Management > User List) corresponding authorization groups as specified in SDS:
• Operator
Yes No
• Supervisor
• Maintenance
• System administrator
• HH Service
□ □
Tick-off checked authorizations groups in SDS. All checked items are ticked-off in the SDS.
Yes No
□ □
Log in as sysadmin Logged in as sysadmin.
Yes No
□ □
Deactivate a user. User is deactivated with data as recorded below:
(Management > User List > Edit user > tick-off Active)
Record user and date / time. • ________________________________________________
Yes No
User
• ______________________ _____________________
Date Time


□ □
Attempt to log in the deactivated user. Deactivated user cannot log in.
Yes No
□ □
Activate the previous deactivated user. User is activated with data as recorded below:
(Management > User List > Edit user > tick-on Active)
Record user and date / time. • ________________________________________________
Yes No
User
• ______________________ _____________________
Date Time
Password management - first log in
□ □
Create a new user. User is created with data as recorded below:
(Management > User List > New user)
Record user and password. • ________________________________________________
Yes No
User
• ________________________________________________
Password
□ □
Log in the previous created user with assigned password of test The password entry is carrier out in a hidden format (password
step no. 7. characters are not shown on the HMI) and a request appears to
change the password.
Yes No
□ □
Enter assigned password of test step 7 again. A request appears that old and new password must not be the .
same.
Yes No


□ □
Change password as specified in SDS. Password change was successful and user is logged in with
Record password. data recorded below:
Yes No
• ________________________________________________
Password
□ □
Log off. User is logged off.
Yes No
□ □
Verify user log in with new created password of test step 10. User is logged in.
Yes No
Password management - password length
□ □
Attempt to change password with less characters as specified in It is not possible to change the password.
SDS.
Yes No
□ □
Tick-off checked password length in SDS. All checked items are ticked-off in the SDS.
Yes No
Password management - supervision of unauthorized attempts
□ □
Attempt to log in with an incorrect password as many times as A message appears that the user is locked.
specified in SDS.
Yes No


□ □
Login as sysadmin. Logged in as sysadmin.
Yes No
□ □
Unlock the previous locked user. User is unlocked.
(Management > User List > Edit User > Tick-off locked)
Yes No
□ □
Tick-off checked number of unauthorized attempts in SDS. All checked items are ticked-off in the SDS.
Yes No
Password management - auto log off
□ □
Log in. User is logged in with data as recorded below:
Record user.
• ________________________________________________
Yes No
User
□ □
Keep the HMI inactive for a time as specified in the SDS. After inactivity time has elapsed the user is logged off and
“SYSTEM” is displayed.
Yes No
□ □
Tick-off checked auto log off time in SDS. All checked items are ticked-off in the SDS.
Yes No


Attachments
□ □
Attach the SDS pages with the ticked-off items to this test Pages are attached to this test protocol.
protocol.
Yes No
HMI reporting
□ □
Verify audit trail and record event time. Changed items caused by previous simulation are listed in audit
trail with event time as recorded below:
Yes No
• ______ : ______ (hh:mm) to ______ : ______ (hh:mm)
End of test

15.3 CSV-OT1000-04 [QMP] - HMI reporting - function

The objective of this test is to verify the • Parameters changed prior to the batch start are displayed on HMI
• Function of HMI reporting. • Batch report chapters comply with the specified requirements in the Software
Design Specification (SDS)
• Content of the batch report chapters complies with the general machine data and
entered / changed data
• Audit trail report contains all changed data
• Alarm report contains all forced fault numbers
• See “chapter 11 general machine set-up” in this test protocol • Att-CSV-OT-15.3, no. 14, total no. of pages ____ Att.-No.: ______
• SDS • Att-CSV-OT-15.3, no. 15, total no. of pages ____ Att.-No.: ______
• Operating manual • Att-CSV-OT-15.3, no. 18, total no. of pages ____ Att.-No.: ______
• Format parameter list • Att-CSV-OT-15.3, no. 19, total no. of pages ____ Att.-No.: ______
• USB flash drive • Att-CSV-OT-15.3, no. 22, total no. of pages ____ Att.-No.: ______
• Att-CSV-OT-15.3, no. 25, total no. of pages ____ Att.-No.: ______

CSV-OT1000-04 [QMP] - HMI reporting - function

Batch management
□ □
Verify current format set-up. Machine is set-up to format as recorded below:
(Management > Format)
Record format name. • ________________________________________________
Yes No
Format name
□ □
Simulate HMI parameter set-up not as specified by changing Not specified machine parameter set-up is simulated as
three machine parameters. recorded below:
Record the changes.
Yes No
• _____________________ __________ __________
Note: Parameter 1 Old value New value
Machine parameter change must not have any impact on
product quality and machine functionality.
• _____________________ __________ __________
Machine parameters are listed in the machine parameter list. Parameter 2 Old value New value
(Service > Machine Settings > Show parameter list of format)
• _____________________ __________ __________
□ □
Create new batch and enter the required batch data. Batch data are entered as recorded below:
Record batch data.
• ________________________________________________
Yes No
Batch name
• ________________________________________________
Batch number


□ □
Record batch start time and user. Batch is started with data as recorded below:
• ________________________________________________
Yes No
Batch start time
• ________________________________________________
User
□ □
Enter the required measurement data. Measurement data are entered as recorded below:
Record measurement record data.
• ________________________________________________
Yes No
Stripe number CW lane 1 | Stripe number CW lane 2
□ □
Start measurement. A consistency check is performed.
The parameters changed prior to the measurement start are
Note: To start a measurement Blister Data need to be filled in, displayed on HMI.
(Tasks >> Measurement) Yes No
Press “Continue / Yes”.

□ □
Measurement is started with data as recorded below:
Record measurement start time and user.
• ________________________________________________
Yes No
Measurement start time
• ________________________________________________
User


□ □
Open guard door at Guard door 1 (guard door / 1A06-1S2). Guard door is opened.
Record forced fault numbers. Forced fault number as recorded below:
Yes No
• ________________________________________________
Fault number
□ □
Force audit trail entries by: Audit trail entries are forced as recorded below:
• Logging off and in with a different user
• Changing three HMI parameter • ________________________________________________
Yes No
• Record the changes. Logged off user
• ________________________________________________
Logged in user
• _____________________ __________ __________

• _____________________ __________ __________

• _____________________ __________ __________



□ □
Set machine back to original condition. Measurement is stopped with data as recorded below:
Stop the measurement.
Record measurement stop time and user. • ________________________________________________
Yes No
Measurement stop time
• ________________________________________________
User
□ □
Close the batch. Batch is stopped with data as recorded below:
Record batch stop time and user. • ________________________________________________
Batch stop time
Yes No
• ________________________________________________
User
□ □
Print the measurement report (i.e. by saving it on a USB flash The measurement report is printed.
drive and printing it).
(Management > File Manager > File Type > Measurement
Report PDF) Yes No


□ □
Verify the measurement report against SDS chapter 9.10 for the Measurement report chapters comply with the specified
following content: requirements in the SDS chapter 9.10.
• Machine information The content of the measurement report chapters complies with
the general machine data and where applicable the entered / Yes No
• Report information
changed data of test step no. 1 to 8.
• Blister data (Blister number CW Lane-1/Lane-2)
• Optional parameter filling head
• Assessment
• Measurement history
• Approval
• User/System logging
• Format overview
• Deviations at measurement start
• Audit trail (Parameter changes)
• Measured values
• Nozzle statistic fillhead
• Strip statistic
• Alarms
• Document Footer ( Machine number, Measurement ID,
Measurement start, Measurement stop, Document ID, Page
number/All Pages)
□ □
Tick-off checked measurement report items in SDS. Pages are attached to this test protocol.
Yes No


□ □
Tick-off checked measurement report items in measurement Pages are attached to this test protocol.
report.
Yes No
□ □
Print the batch report (i.e. by saving it on a USB flash drive and The batch report is created and printed.
printing it).
(Management > File Manager > File Type > Batch Report PDF)
Yes No
□ □
Verify the batch report against SDS for the following content: Batch report chapters comply with the specified requirements in
• Machine information the SDS.
• Report information
Yes No
• Batch information
• Batch history
• Approval
• Overview of measurements
• Lane statistics
• Nozzle mean values
• Total statistic
□ □
Tick-off checked batch report items in SDS. Pages are attached to this test protocol.
Yes No
□ □
Tick-off checked batch data items in batch report. Pages are attached to this test protocol.
Yes No


Audit trail report
□ □
Create an audit trail report for the time period of performing this The audit trail report is created and printed.
test.
Print the audit trail report (i.e. by saving it on a USB flash drive
and printing it). Yes No
(Management > File Manager > File Type > Audit Trail Report
PDF)
□ □
Verify the audit trail report for the following content: The audit trail report contains all changed data recorded in test
• Parameter changes (old-, new value) step no. 2, 9, 10 and 11.
• Logons (logging in, logging off)
Yes No
□ □
Tick-off checked items in audit trail report. Pages are attached to this test protocol.
Yes No
Alarm report
□ □
Create an alarm report for the time period of performing this The alarm report is created and printed.
test.
Print the alarm report (i.e. by saving it on a USB flash drive and
printing it). Yes No
(Management > File Manager > File Type > Alarm Report PDF)
□ □
Verify the alarm report. The alarm report contains all forced fault numbers recorded in
test step no. 6.
Yes No


□ □
Tick-off checked forced fault numbers in alarm report. Pages are attached to this test protocol.
Yes No
End of test

15.4 CSV-OT1000-06 [QMP] - Disaster recovery

The objective of this test is to verify the • Documentation is present
• Documentation • Data medium is present
• Data medium
for the system recovery.

• N.a.

CSV-OT1000-06 [QMP] - Disaster recovery

System recovery - HH machine HMI and HH machine PLC
□ □
Verify documentation for system recovery. Document is present (printout or file) as recorded below:
Record Binder name, Machine No. and version.
Yes No
• ________________________________________________
Binder name
• ________________________________________________
Machine No.
• User and Password as record below

□ □
Yes No
• ________________________________________________
Version
• HH customer Recovery Edition as record below

□ □
Yes No
• ________________________________________________
Version
• HH Schneider Controller as record below

□ □
Yes No
• ________________________________________________
Version

CSV-OT1000-06 [QMP] - Disaster recovery

□ □
Verify documentation for system recovery. Document is present (printout or file) as recorded below:
Record License Certificate and version. License Certificate
Yes No
• ________________________________________________
License Certificate
• ________________________________________________
Version
□ □
Verify data medium for system recovery. Data medium for system recovery is present as recorded below:
Record data medium.
Yes No
• ________________________________________________
Data medium
End of test

15.5 CSV-OT1000-08 [QMP] - HMI reporting - content

The objective of this test is to verify the • The reports contain the test period from first test performed to the last test
• Content of HMI reporting.
• All tests in this test protocol must be performed prior performing this test
• USB flash drive
Note: This test must be always performed at the end of OQ from the first to the last
test execution to save alarms and audit trails.

CSV-OT1000-08 [QMP] - HMI reporting - content

Content of HMI reporting - audit trail
□ □
Create an audit trail report over the entire test duration - from The audit trail report is created and saved on a USB flash drive.
the first test to the last test performed.
(Management > Audit and Alarm > Filter > Audit Trail)
Yes No
Save the audit trail report on a USB flash drive.
(Management > File Manager > File Type > Audit Trail Report
PDF)
□ □
Verify the audit trail report. The audit trail report contains the test period from first test
performed to the last test.
Yes No
□ □
Store file of audit trail report. File of audit trail report is present as recorded below:
Record file name and storage place.
• ________________________________________________
Yes No
File name
• ________________________________________________
Storage place

CSV-OT1000-08 [QMP] - HMI reporting - content

Content of HMI reporting - alarm history
□ □
Create an alarm report over the entire test duration - from the The alarm report is created and saved on a USB flash drive.
first test to the last test performed.
(Management > Audit and Alarm > Filter > Alarm)
Yes No
Save the alarm report on a USB flash drive.
(Management > File Manager > File Type > Alarm Report PDF)
□ □
Verify the alarm report. The alarm report contains the test time period of first test
performed to the last test.
Yes No
□ □
Store file of alarm report. File of alarm report is present as recorded below:
Record file name and storage place.
• ________________________________________________
Yes No
File name
• ________________________________________________
Storage place
End of test

16 pFMEA tests
16.1 OT1100-01 [FMEA-CT] - Function of weighing cells
The objective of this test is to verify the • Display of alarm
• Functional process of the weighing cells.

OT1100-01 [FMEA-CT] - Function of weighing cells

Functional process of the station
□ □
Simulate weight is not within a certain range by open three Three chambers are opened, powder is sucked off and
chambers from blister strip, suck off powder and close these chambers are closed.
chambers.
Note down sucked off powder chamber numbers: Yes No
□ □
Start weighing process. Weighing process is started.
Yes No
□ □
Verify visually the weighing process of the three chambers. Display of alarm: [Alarm], at these three chambers.
(Tasks > Measurement results > Measurement results)
Yes No
End of test

16.2 OT1100-02 [FMEA-CT] - Weight accuracy of weighing cell

The objective of this test is to verify the • The calculated Cg and Cgk values are both higher than 1,33 for a target weight
• Weighing accuracy. of 13mg.
• See “chapter 11 general machine set-up” in this test protocol • Att-OT-16.2, no. 4, total no. of pages ____ Att.-No.: ________
• External weights (60 weights)

OT1100-02 [FMEA-CT] - Weight accuracy of weighing cell

Weighing accuracy - weighing cell lane 1 and 2
□ □
Prepare machine for weighing accuracy. Before starting the Exhaust and blowing air hose =1160.2 is disconnected.
measurement disconnect exhaust and blowing air hose
=1160.2.
Yes No
□ □
Insert 30 external weights in an empty blister (totally 60 External weights are inserted in an empty blister. Machine
weights) at lane 1 and 2. Run the machine with this prepared weigh data of 30 weighing cycles per lane is recorded.
blister and record machine weigh data for each weighing cycle.
Yes No
□ □
Calculate the Cg and Cgk values for lane 1 and record values. Calculated Cg and Cgk values as listed below:
= ________________________ > 1,33

Yes No
= ____________________ > 1,33
The calculated Cg and Cgk values are both higher than 1,33.
□ □
Calculate the Cg and Cgk values for lane 2: and record values. Calculated Cg and Cgk values as listed below:
= ________________________> 1,33
Yes No
= ____________________> 1,33
The calculated Cg and Cgk values are both higher than 1,33.

OT1100-02 [FMEA-CT] - Weight accuracy of weighing cell

Attachments
□ □
Attach the pages of the recorded weigh data and weighing Pages are attached to this test protocol.
accuracy to this test protocol.
Yes No
End of test

16.3 OT1110-01 [FMEA-CT] - Function of weighing receptacle lifting unit

The objective of this test is to verify the • Functional process of the station complies with the specified requirements in the
• Functional process of the station. Functional Design Specification (FDS)
• See “chapter 11 general machine set-up” in this test protocol • Att-OT-16.3, no. 2, total no. of pages ____ Att.-No.: _______
• FDS

OT1110-01 [FMEA-CT] - Function of weighing receptacle lifting unit

Functional process of the station
□ □
Run the machine with one blister strip and observe machine Machine is running.
operation. The functional process of the station complies with the specified
Verify visually the functional process of the station against FDS. requirements in the FDS:
Yes No
• No damage of blister pockets by correct function of the foil
clamp handles
□ □
Tick-off checked items in FDS. Pages are attached to this test protocol.
Yes No
End of test


17 Release for next qualification phase

It is verified that each deviation is documented and classified in the Deviation Assessment and each Deviation
Assessment is listed in the Deviation Summary of the Deviation Report.
Verified by
(name / date / signature)
Following amount of open deviations are listed in the Deviation Summary.
Number of open Number of open

minor deviations major deviations
Documented by
General comment to open minor deviations:

The open minor deviations do not necessarily need to be closed before the next qualification phase. They can be
transferred to the next qualification phase.
General comment to open major deviations:

In order to transfer open major deviations to the next qualification phase, a statement must be issued.
Statement to release for next qualification phase

(only required when open major deviations are transferred to the next qualification phase)
Comment
(if required)
Documented by
Approved by

HH-4299.044-OQ-MDPI Checkweigher-00 - V1 - 0 - Eng

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Operational Qualification

Machine type: MDPI Checkweigher

Machine type: MDPI Checkweigher

Created by Birsen Öztürk 07 Mar '23

DBL Pharmaceuticals Ltd.

Post-Approval by DBL Pharmaceuticals Ltd.

Doc-ID: HH-4299.044-OQ-MDPI Checkweigher-00

Machine type: MDPI Checkweigher

3 Reference documents .............................................................................................................. 5

7 Auxiliaries for test performance.............................................................................................. 6

8 Deviation handling ................................................................................................................... 6

9 Signature list ............................................................................................................................ 7

10 Formats, materials and products ............................................................................................ 8

11 General machine set-up ........................................................................................................... 9

12 Date and time verification on HMI ........................................................................................... 9

14 HH standard tests: Operational Tests (OT) .......................................................................... 11

15 HH standard tests: Computer System Validation - Operational Tests (CSV-OT) ............... 18

16 pFMEA tests ........................................................................................................................... 42

17 Release for next qualification phase..................................................................................... 49

Doc-ID: HH-4299.044-OQ-MDPI Checkweigher-00

Machine type: MDPI Checkweigher

Doc-ID: HH-4299.044-OQ-MDPI Checkweigher-00

Machine type: MDPI Checkweigher

2.2 Project specific

Doc-ID: HH-4299.044-OQ-MDPI Checkweigher-00

Machine type: MDPI Checkweigher

5.1 Project data

5.2 Equipment data

Doc-ID: HH-4299.044-OQ-MDPI Checkweigher-00

Machine type: MDPI Checkweigher

7 Auxiliaries for test performance

Risk of complete functional loss of the product due to

Potential functional loss of the product due to

Deviations that require correction before starting the production.

No functional loss of the product. No effect on the product quality due to

Doc-ID: HH-4299.044-OQ-MDPI Checkweigher-00

Machine type: MDPI Checkweigher

9.2 DBL Pharmaceuticals Ltd. team

Doc-ID: HH-4299.044-OQ-MDPI Checkweigher-00

Machine type: MDPI Checkweigher

10 Formats, materials and products

Doc-ID: HH-4299.044-OQ-MDPI Checkweigher-00

Machine type: MDPI Checkweigher

11 General machine set-up

12 Date and time verification on HMI

Doc-ID: HH-4299.044-OQ-MDPI Checkweigher-00

Machine type: MDPI Checkweigher

Doc-ID: HH-4299.044-OQ-MDPI Checkweigher-00

14 HH standard tests: Operational Tests (OT)

Test result (to be filled in by reviewer) Reviewed by (date / signature)

Passed Failed, see deviation no. _____

Doc-ID: HH-4299.044-OQ-MDPI Checkweigher-00

OT1000-00 [QMP] - IQ deviations

Doc-ID: HH-4299.044-OQ-MDPI Checkweigher-00

14.2 OT1000-01A [QMP] - Emergency Stop

Test result (to be filled in by reviewer) Reviewed by (date / signature)

Passed Failed, see deviation no. _____

Doc-ID: HH-4299.044-OQ-MDPI Checkweigher-00

OT1000-01A [QMP] - Emergency Stop

Doc-ID: HH-4299.044-OQ-MDPI Checkweigher-00

14.3 OT1000-02A [QMP] - Guard doors locked

Test result (to be filled in by reviewer) Reviewed by (date / signature)

• _________

• _________

• _________

• _________

• _________