Your signature indicates that the preparation of this file (Edit/Revision) complies with the validation project of the equipment operational requirements of GMP and industrial production process for bin blender....
1. HZD1500 Bin Blender
SAINTYCO INTERNATIONAL GROUP
Serial No: 170205
Year of Mfg: 2017.02
PART3: General Part _ Operation Qualification (GP- OQ)
Equipment: Bin Blender, Machine No.: HZD1500
HZD1500 BIN BLENDER
Operational Qualification (OQ) Protocol
2. SAINTY INTERNATIONAL GROUP
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JN/JS/OQ-HZD1500
Operational Qualification Protocol for HZD1500 Bin Blender Version:V01
Writer‘s signature
Your signature indicates that the preparation of this file (Edit/Revision) complies with the
validation project of the equipment operational requirements of GMP and industrial production
process for bin blender. It also fully reflects the necessary tasks that shall be completed during
the validation procedure, and it can implement the Operational Validation of the HZD1500 Bin
Blender.
Name Title Signature Date Unit
Kevin Project manager April 1st
,2017 SAINTYCO
Checker‘s signature
Your signature indicates you have carefully read this document and have confirmed its
exactness and this document fully reflects the validation tasks, and it can implement the
Operational Validation of the HZD1500 Bin Blender.
Name Title Signature Date Unit
Wenju Pei Technician April 1st
,2017 SAINTYCO
Approver’s signature
Your signature indicates that this document complies with the general plan of enterprise
validation, the technical production standards all the including files and information are
sufficient and can be directly applied. After the approval, any modification or correction to the
aim of this document or to the validation standard must be done in improving this document,
and before the execution of the modified/corrected document, it must be approved
Name Title Signature Date Unit
Lei Zhang Technical Manager April 1st
,2017 SAINTYCO
3. SAINTY INTERNATIONAL GROUP
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Operational Qualification Protocol for HZD1500 Bin Blender Version:V01
TABLE OF CONTENTS
1 PURPOSE.......................................................................................................................................................... 4
2 VALIDATION SCOPE...........................................................................................................................................4
3 PROTOCOL CHECKING..................................................................................................................................... 4
4 ORGANIZATION AND RESPONSIBILITIES.......................................................................................................... 4
5 SYSTEM DESCRIPTION.....................................................................................................................................5
5.1 NAMEPLATE................................................................................................................................................... 5
5.2 MAIN FUNCTIONS...........................................................................................................................................5
5.3 TECHNICAL USE.............................................................................................................................................5
5.6 REQUIREMENTS.............................................................................................................................................6
6 VALIDATION PROCEDURES AND RECORDS................................................................................................... 7
6.1 DOCUMENTS QUALIFICATION........................................................................................................................7
6.2 IQ QUALIFICATION.........................................................................................................................................7
6.3 MANUAL SETTING AND CALLING OF BLENDING TECHNICAL PROCEDURES (PARAMETERS).......................7
6.4 CLAMPING AND DISMANTLING OF THE BIN.................................................................................................. 8
6.5 AUTO LIFTING AND FALLING OF THE BIN.......................................................................................................9
6.6 OPERATIONAL QUALIFICATION OF ROTARY BLENDING.................................................................................9
6.7 QUALIFICATION OF THE BIN POSITIONING..................................................................................................10
6.8 PRINTING OF TECHNICAL RECORDS...........................................................................................................10
6.9 SYSTEM PROTECTION................................................................................................................................. 11
6.10 QUALIFICATION OF THE FUNCTIONS OF THE TOUCH PANEL....................................................................11
6.11 TRAINING................................................................................................................................................... 12
6.12 ATTACHED PAGE OF THE RECORDS......................................................................................................... 12
7 DEVIATIONS...................................................................................................................................................12
7.1 DEVIATIONS LIST......................................................................................................................................... 12
7.2 DEVIATIONS REPORT...................................................................................................................................12
8 ATTACHMENTS LIST.......................................................................................................................................12
9 OQ EVALUATION OF OQ RESULTS AND SUGGESTIONS.......................................................................... 13
10 CHECKING AND APPROVAL..........................................................................................................................13
11 ALTERATION CONTROL..................................................................................................................................13
RECORD:
DOCUMENTS QUALIFICATION.................................................................................................................................... 14
IQ QUALIFICATION...................................................................................................................................................... 15
MANUAL SETTING AND CALLING OF BLENDING PROCESS PROCEDURES (PARAMETERS)
错误!未定义书签。
CLAMPING AND DISMANTLING OF THE BIN...............................................................................................................17
4. SAINTY INTERNATIONAL GROUP
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QUALIFICATION OF AUTO LIFTING AND FALLING...................................................................................................... 18
OPERATIONAL QUALIFICATION OF ROTARY BLENDING............................................................................................19
QUALIFICATION OF BIN POSITIONING........................................................................................................................20
PRINTING OF TECHNICAL RECORDS......................................................................................................................... 21
SYSTEM PROTECTION................................................................................................................................................ 22
QUALIFICATION OF FUNCTIONS OF THE TOUCH PANEL...........................................................................................23
TRAINING..................................................................................................................................................................... 24
ATTACHED PAGE OF THE RECORD............................................................................................................................ 25
DEVIATIONS LIST.........................................................................................................................................................25
DEVIATIONS REPORT.................................................................................................................................................. 25
ATTACHMENTS LIST.....................................................................................................................错误!未定义书签。
CHECKING AND APPROVAL OF THE EXECUTION......................................................................................................26
APPENDIX;
APPENDIXⅠ: OQ RESULTS EVALUATION AND SUGGESTION..............................................................................26
5. SAINTY INTERNATIONAL GROUP
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1.Purpose
The purpose of this protocol is to provide guiding and technical standards to the operation
qualification of the HZD1500 Bin Blender.
This is to establish the validation protocol in order to obtain a document certifying that the
HZD1500 Bin Blender has been operated according to operational requirements of bin blender.
The acquisition of this document proves that the operation of the HZD1500 Bin Blender has
been implemented according to the approved protocol.
This protocol is the third part of the validation protocol of the HZD1500 Bin Blender:
Operational Qualification (OQ).
2.Validation Scope
Validation scope covers
functions,
operation procedures,
operation SOP,
training and other of the Bin Blender manufactured by SAINTYCO that is installed in
Room ______________, ID No.______________
Validation does not include separated validation of historic data.
3.Protocol Checking
At the following times, please check and ensure the suitability of this protocol:
When the principal part of the validation has been modified
When the validation scope has been modified
When the design has been modified
Prior to the execution of the OQ
During the review after the OQ has been completed
4.Organization and Responsibilities
Define roles and responsibilities properly, according to their concrete division of labor.
All the personal participating to the execution of this protocol must provide their sample of
signature.
6. SAINTY INTERNATIONAL GROUP
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5.System Description
5.1 Nameplate
NAME: Blender
MODEL:HZD1500
POWER SUPPLY: 440V/60Hz
SPEED: 3~15r/min
RATED CAPACITY:1500L
POWER: 10.5 kW
5.2 Main functions
Manual clamping and dismantling of the bin
Auto lift and fall of the bin
Adjustable blending rotary speed between 3~15rpm
Blending finished, bin positions automatically
Blending finished, print technical record
Manual setting and calling of blending technical procedure (Parameters)
Failures alarms during automatic operation process
5.3 Technical use
The equipment is mainly used for blending dried granules or powder.
5.4 Main technical parameters see Table B3-01
Table B3-01 Main technical parameters
Model HZD1500
Adaptive bin type LDZ1500 LDZ1000-1500 LDZ500-1500
Capacity L 1500 1000 500
Working load kg 750
Working speed r/min 3~15
Mixing time min 1~60
Mixing motor power kW 7.5
Lifting motor power kW 3
7. SAINTY INTERNATIONAL GROUP
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5.5 Manufacturer
Sanity International Group
402#, Tower-1, Pearl Mansion, Block-3, Rui’an city, Zhejiang Province, China
Website:www.saintyco.com
Email:sainty@saintyco.com
Tel:(86)0577-66612826
5.6 Requirements
5.6.1 Every validation results shall be truly and integrally filled in the Operational Qualification
Report OQR, this manual has provided a template of OQR.
5.6.2 Inspector and checker will decide whether the validation results are up to scratch, OQR
shall clearly indicate whether the validation has been passed. Inspector and checker shall sign
and record the date on the related chapters and sections; putting a tick as signature is
forbidden. On places that are not suitable to the system, please use N/A for indicating and
write the reason the suitable place.
5.6.3 The inspection file shall be kept as part of the inspection records, all the main accidents
should be recorded on the inspection file, such as system damages or failures causing the stop
of the inspection.
5.6.4 A group (or a day) of validation accomplished, validation group shall summarize briefly
the formed results or datum and shall conclude it (including inspection datum which are not up
to standard).
5.6.5 All deviations appeared during validation shall be recorded in the Deviation Report (DR).
5.6.6 After analyzing inconsistent items and deviations, they shall be validated again; this
validation can used actual protocol or change for another mode of qualification.
5.6.7 Every validation finished, results or records shall be analyzed again to form the
Operational Qualification Report. The Report should explicitly mention whether this validation
has been passed or not.
5.6.8 All the records, IQR, DR and the lastly formed Operational Qualification Report shall be
arranged, filled in a document for archiving and should be kept and saved as part of the
equipment dossier
8. SAINTY INTERNATIONAL GROUP
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6. Validation Procedures and Records
6.1 Documents Qualification
Purpose:
Qualify the documents pursuant to operational qualification of the blender system are fully
valid.
Procedure
Check carefully the following documents and qualify their integrality and
validity:
HZD1500 Bin Blender Product Manual
Electric configuration list
Qualification standard
The above applicable documents are the newest editions of the related system
Record
Record the validation result in OQR01;
Record deviation appeared during the qualification process in the deviation report.
6.2 IQ Qualification
Purpose
Qualify the IQ has been successfully executed and approved.
Procedure
Qualify the IQ document exists and has been executed and approved, moreover
errors have been clearly indicated. All the IQ errors shall have been evaluated and
ensured that these errors won’t influence the results of OQ.
Qualification standard
IQ has been executed and approved; moreover all the IQ errors that may influence
the OQ results have been treated or clearly indicated.
Record
Record the validation result in OQR02;
Record deviation appeared during the qualification process in the deviation report.
6.3 Manual setting and calling of blending technical procedures (Parameters)
Purpose
9. SAINTY INTERNATIONAL GROUP
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Qualify the technical procedures management (Setting and calling) of the blender
system complies with requirements of technical management for blending operation.
Procedure
Refer to the product manual or draft SOP operation and check the following items of
OQ:
A) Setting contents of technical procedures:
Technical procedures/Medicine name
Blending time
Blending speed
Storage code
B) Number of pre-set technical procedure groups
C) Qualification of calling of technical procedure
Acceptable standard
The technical procedures management (Setting and calling) of the blender system
complies with requirements of technical management for blending operation.
Record
Record the validation result in OQR03;
Record deviation appeared during the qualification process in the deviation report.
6.4 Clamping and dismantling of the Bin
Purpose
Qualify the clamping and dismantling of the bin complies with requirements for
operation and running.
Procedure
According to “Product manual” or “Operation SOP”, qualify clamping and dismantling
tasks of the bin:
Connection of the bin to the main machine
Operation process of the bin
Qualification of bin in position
Qualification standard
The clamping and dismantling of the bin complies with requirements for operation
and running.
10. SAINTY INTERNATIONAL GROUP
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Record
Record the validation result in OQR04;
Record deviation appeared during the qualification process in the deviation report.
6.5 Auto lifting and falling of the bin
Purpose
Qualify the process and the stability of the auto lifting and falling of the bin comply
with URS and DQ requirements.
Procedure
Refer to the product manual or draft SOP operation and check the following items of
OQ:
Lifting reducer
Lifting screw-nut pairs
Acceptable standard
The process and the stability of the auto lifting and falling of the bin comply with URS
and DQ requirements.
Record
Record the validation result in OQR05;
Record deviation appeared during the qualification process in the deviation report.
6.6 Operational Qualification of rotary blending
Purpose
Qualify the operational reliability and stability of blender comply with design
requirements.
Procedure
Refer to the product manual or draft SOP operation and check the following items of
OQ:
Blending reducer
Blending time
Blending speed
Stability of the blending process
Acceptable standard
The operational reliability and stability of blender comply with design requirements.
11. SAINTY INTERNATIONAL GROUP
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Record
Record the validation result in OQR06;
Record deviation appeared during the qualification process in the deviation report.
6.7 Qualification of the bin positioning
Purpose
Qualify, on blending finishing, the correct positioning of the bin complies with design
requirements.
Procedure
Refer to the product manual or draft SOP operation, execute:
Manual positioning
Auto positioning
Positioning after a manual stop of the process
Acceptable standard
The reproducibility of the bin positioning is fine and in every condition the bin can be
positioned in the same state.
Record
Record the validation result in OQR07;
Record deviation appeared during the qualification process in the deviation report.
6.8 Printing of technical records
Purpose
Qualify the printing of technical records complies with requirements for management
of batch number and quality traceability.
Procedure
Refer to the product manual or draft SOP operation, qualify
Instant printing after blending is finished
Reading and printing of historic records
Acceptable standard
The printing of technical records complies with requirements for management of
batch number and quality traceability, and is consistent with product manual or SOP
descriptions.
12. SAINTY INTERNATIONAL GROUP
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Operational Qualification Protocol for HZD1500 Bin Blender Version:V01
Record
Record the validation result in OQR08;
Record deviation appeared during the qualification process in the deviation report.
6.9 System protection
Purpose
Qualify the system protection of the blender complies with safety
requirements.
Procedure
Qualify the following items:
Emergency stop
Operation interruption
Alarms
Mechanical safety
Acceptable standard
The system protection of the blender complies with safety requirements.
Record
Record the validation result in OQR09;
Record deviation appeared during the qualification process in the deviation report.
6.10 Qualification of the functions of the touch panel
Purpose
Qualify the functions of the touch panel are consistent with pre-qualified
contents.
Procedure
Qualify the following items:
Touch panel
Buttons
Acceptable standard
The functions of the touch panel are consistent with pre-qualified contents.
Record
Record the validation result in OQR10;
Record deviation appeared during the qualification process in the deviation report.
13. SAINTY INTERNATIONAL GROUP
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6.11 Training
Purpose
Qualify the relative personnel has the suitable capacity for the system using, servicing
and daily management.
Procedure
Check the training plan and implementation record of the personnel for the system
using, servicing and daily management, qualify they have received effective training.
Acceptable standard
The personnel for the system using, servicing and daily management has received
effective training, and has the suitable capacity.
Record
Record the validation result in OQR11;
Record deviation appeared during the qualification process in the deviation report.
6.12 Attached page of the records
If the main record pages are not enough, the record like OQR12 can be used, then give a
clear indication of the title of the number and Qualification record reference.
Deviations
7.1 Deviations list
Collect all the deviations appeared during the OQ activities to form the deviations list and
indicate date of solution.
7.2 Deviations report
Record all the deviations and their management occurred during the protocol execution
process and analyze their effects on Validation conclusion.
Record the records contents, cause analysis, improved situations and effects on
Validation conclusion in the deviations report.
8. Attachments list
Collect all related documents, records, videos. CDs, use them as attachments for the
validation report. Compile the attachment list, specify the pages and use conditions.
14. SAINTY INTERNATIONAL GROUP
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9. OQ Evaluation of OQ results and suggestions
Collect all records and reports of chapters 6, 7 and 8. Validation group uses procedures
below to evaluate the results and to put forward some suggestions:
Check the review of the qualification process
Check and analyze the records
Check and analyze the deviations report
Draft out the conclusion
Discuss and approve the report
10. Checking and Approval
Report is checked and approved by authorized person.
Validation Report and its attachments shall be arranged, filled in a document for archiving
and should be kept and saved as part of the equipment dossier.
Appendix I have provided an example of Operational Validation Report.
11. Alteration control
Any change of the equipment must be checked and approved by both parts, and then
changed files should be archived.
15. SAINTY INTERNATIONAL GROUP
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OQR of HZD1500 Bin Blender
Record No. OQR:01 Manufacturer SAINTYCO
Qualify/Date Check/Date
name:Documents Qualification
Document name
(PASS) (FAIL) (N/A)
Product Manual
Electric configuration list
Other:
Any deviation? □(YES) □(NO)
Deviation recorded in DR, DR No. is:DR
Recorder Checker Checker Checker
Signature
Date
16. SAINTY INTERNATIONAL GROUP
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OQR of HZD1500 Bin Blender
Record No. OQR02 Manufacturer SAINTYCO
Qualify/Date Check/Date
Name:IQ Qualification
NO. Description Expected result Measured result Conclusion
1 Qualify the IQ document exists and
has been executed and approved,
moreover errors have been clearly
indicated. All the IQ errors shall
have been evaluated and ensured
that these errors won’t influence the
results of OQ.
□ PASS
□ FAIL
Other:
Any deviation? □(YES) □(NO)
Deviation recorded in DR, DR No. is:DR
Recorder Checker Checker Checker
Signature
Date
17. SAINTY INTERNATIONAL GROUP
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OQR of HZD1500 Bin Blender
Record No. OQR:03 Manufacturer SAINTYCO
Qualify/Date Check/Date
Manual setting and calling of blending process procedures (Parameters)
Item Description Conclusion
Contents of process
procedure setting
Process procedure/Medicine name: 10 numbers or
letters code
□Yes □No
Blending time: can be set at will 1~60 min. □Yes □No
Blending rotation speed: 3~15rpm □Yes □No
Storage code:0~49 □Yes □No
Number of pre-set process
procedure groups
50 Groups □Yes □No
Calling of process
procedure
Input process procedure code: confirm a group
between 0~49
□Yes □No
Confirmation of the technical parameter in the menu □Yes □No
Other:
Any deviation? □(YES) □(NO)
Deviation recorded in DR, DR No. is:DR
Recorder Checker Checker Checker
Signature
Date
18. SAINTY INTERNATIONAL GROUP
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OQR of HZD1500 Bin Blender Record No. OQR:04 Manufacturer SAINTYCO
Qualify/Date Check/Date
Name: Clamping and dismantling of the bin
Item Description Conclusion
Checking of the bin Bin is covered with a lid and clamped with a hook,
butterfly valve is closed
□Yes □No
Connection of the bin to
the main machine
The bin is pushed into rotary frame, four legs of the bin
are aligned with the clamping devices on chassis of
rotary frame
□Yes □No
Clamp in place process
2/3 area of the stacking plate at the bottom of bin is
reliably pressed when clamped
□Yes □No
Clamp sensor receives signal that bin is clamped in
place and will stop
□Yes □No
Lowered in place
qualification
When lowered in place, motor will auto stop □Yes □No
Other:
Any deviation? □(YES) □(NO)
Deviation recorded in DR, DR No. is:DR
Recorder Checker Checker Checker
Signature
Date
19. SAINTY INTERNATIONAL GROUP
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OQR of HZD1500 Bin Blender
Record No. OQR:05 Manufacturer SAINTYCO
Qualify/Date Check/Date
Name:Qualification of auto lifting and falling
Item Description Conclusion
Lifting motor Stable operation of motor, operation without oil leakage □Yes □No
Screw-nut pairs Continuous Bin lifting and falling without any block □Yes □No
Operation noise on fully loaded □Yes □No
standard value measured value
≤75dB(A)
Positioning
confirmation
Sensors of the clamping device sends stop signal when bin
clamped in position
□Yes □No
Bin fallen to ground position, motor stops automatically □Yes □No
Other:
Any deviation? □(YES) □(NO)
Deviation recorded in DR, DR No. is:DR
Recorder Checker Checker Checker
Signature
Date
20. SAINTY INTERNATIONAL GROUP
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OQR of HZD1500 Bin Blender Record No. OQR:06 Manufacturer SAINTYCO
Qualify/Date Check/Date
Name: Operational Qualification of rotary blending
Item Description Conclusion
Blending reducer
Continuous stabile of operation current, the current is not more than
110% of the rated value of the motor ( )A
□Yes □No
Operation of reducer without oil leakage or abnormal noise □Yes □No
After 20min continuous operation, temperature rise at the middle of
the motor housing is not more than 35°
□Yes □No
Blending time
Mixing time:1~60min, time deviation is within the 3% of set value; for
example: on empty load condition: set one mixing speed, and use
several different mixing time , measured with stopwatch
□Yes □No
set value measured valve
10min
30min
60min
Stability of
blending process
On blending operation, left/right frames haven’t obvious vibration □Yes □No
There’s no displacement of the bin the rotary frame □Yes □No
Blending speed
Rotation speed is 3~15r/min, when without load, bin rotates
10 circle with rotation speed 3 r/min, and work out its rotation speed
□Yes □No
setting value:3 r/min actual value
Rotation speed is 3~15r/min, when without load, bin rotates
10 circle with rotation speed 8 r/min, and work out its rotation speed
□Yes □No
setting value:8 r/min actual value
Rotation speed is 3~15r/min, when without load, bin rotates
10 circle with rotation speed 15 r/min, and work out its rotation speed
□Yes □No
setting value:15 r/min actual value
Other:
Any deviation? □(YES) □(NO)
Deviation recorded in DR, DR No. is:DR
Recorder Checker Checker Checker
Signature
Date
21. SAINTY INTERNATIONAL GROUP
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OQR of HZD1500 Bin Blender Record No. OQR:07 Manufacturer SAINTYCO
Qualify/Date Check/Date
Name:Qualification of bin positioning
Item Description Conclusion
Auto positioning
On auto operation ending, bin auto positions to
original blending position
□Yes □No
After positioning, check visually the rotary frame is
vertical to the ground
定位转速 Positioning rotation speed: 3rpm
Positioning after a manual
process stop
After manual stop of auto procedure, manual
positioning can be used
□Yes □No
After positioning, check visually the rotary frame is
vertical to the ground
Positioning rotation speed: 3rpm
Manual positioning
On failure of auto positioning, use manual
positioning
□Yes □No
After positioning, check visually the rotary frame is
vertical to the ground
Positioning rotation speed: 3rpm
Other:
Any deviation? □(YES) □(NO)
Deviation recorded in DR, DR No. is:DR
Recorder Checker Checker Checker
Signature
Date
22. SAINTY INTERNATIONAL GROUP
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OQR of HZD1500 Bin Blender Record No. OQR:08 Manufacturer SAINTYCO
Qualify/Date Check/Date
Name: Printing of technical records
Item Description Conclusion
Instant printing on
blending finishing
Date, format like ××××Y××M××D □Yes □No
Operator code, 4 letters or numbers □Yes □No
Medicine name, 10 letters or numbers □Yes □No
Medicine batch number, 10 letters or numbers □Yes □No
Blending time, ××min. □Yes □No
Blending speed, ××rpm
□Yes □No
Reading of historic
record
Can auto record the latest 20 groups of auto operation □Yes □No
On records searching menu, records can searched and
printed
□Yes □No
Printing of historic
record
Instant printing on printing content order □Yes □No
Date is the blending date □Yes □No
Other:
Any deviation? □(YES) □(NO)
Deviation recorded in DR, DR No. is:DR
Recorder Checker Checker Checker
Signature
Date
23. SAINTY INTERNATIONAL GROUP
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OQR of HZD1500 Bin Blender Record No. OQR:09 Manufacturer SAINTYCO
Qualify/Date Check/Date
Name: System protection
Item Description Conclusion
Emergency stop
Emergency stops are set on main operation panel and left frame □Yes □No
Press the emergency stop switch to stop the whole operation □Yes □No
On pressing the emergency stop switch, alarm device executes
acoustic and optical alarm
□Yes □No
On pressing the emergency stop switch, touch panel displays
“Emergency Stop” menu
□Yes □No
Operation
interruption
Human interruption (like emergency stop, system suspend),
touch panel displays relative menu
□Yes □No
Start after power-cut, touch panel displays “System power off”
menu
□Yes □No
Resume interruption, system indicates with acoustic and optic
alarm
□Yes □No
Alarms
On pressing the emergency stop, system alarms □Yes □No
Mechanical protection guardrail is carried out by the
photoelectric switch
□Yes □No
Other:
Any deviation? □(YES) □(NO)
Deviation recorded in DR, DR No. is:DR
Recorder Checker Checker Checker
Signature
Date
24. SAINTY INTERNATIONAL GROUP
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OQR of HZD1500 Bin Blender Record No. OQR:10 Manufacturer SAINTYCO
Qualify/Date Check/Date
Name: Qualification of functions of the touch panel
Item Description Conclusion
Touch panel Start system, background light lights; stop system,
background light extinguishes
□Yes □No
Button
Operation
buttons
Choosing a button of the panel, relative operation menu
shall appear, such as operation option, auto, manual and
so on; it shall be consistent with expected design.
□Yes □No
Printing
button
Printing button of touch panel, the printer prints all the
stored datum(operator No., print date, batch No….related
print see TR08 )
□Yes □No
Other:
Any deviation? □(YES) □(NO)
Deviation recorded in DR, DR No. is:DR
Recorder Checker Checker Checker
Signature
Date
25. SAINTY INTERNATIONAL GROUP
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OQR of HZD1500 Bin Blender Record No. OQR:11 Manufacturer SAINTYCO
Qualify/Date Check/Date
Name: Training
Training project name Training project No.
Training record No.
Training contents
Equipment system and basic machine configuration
knowledge training
System work principle training
SOP training
System daily management and maintenance knowledge
training
Other knowledge
Evaluation of training effects Operators, equipment administrant and maintenance
personnel control the knowledge and skill of their own
job requirements.
Conclusion
Other:
Any deviation? □(YES) □(NO)
Deviation recorded in DR, DR No. is:DR
Recorder Checker Checker Checker
Signature
Date
26. SAINTY INTERNATIONAL GROUP
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Operational Qualification Protocol for HZD1500 Bin Blender Version:V01
OQR of HZD1500 Bin Blender Record No. OQR:12 Manufacturer SAINTYCO
Qualify/Date Check/Date
Name:Attached page of the record
Record No. OQR Record name Pages
Total pages:
Page No.
OQR of HZD1500 Bin Blender Record No. OQR:13 Manufacturer SAINTYCO
Qualify/Date Check/Date
Name:Deviations list
Deviation No. Qualification
record No.
Description Date of solution
OQR of HZD1500 Bin Blender Record No. OQR:14 Manufacturer SAINTYCO
Qualify/Date Check/Date
Name:Deviations report
Deviation No. Record No.
Déviations description:
Signature Date
Reason analysis:
Signature Date
Improvement measure: Improvement result:
Signature/Date Signature/Date
Improvement results have positive effects on
operation validation
Yes No
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Operational Qualification Protocol for HZD1500 Bin Blender Version:V01
OQR of HZD1500 Bin Blender Record No. OQR:16 Manufacturer SAINTYCO
Qualify/Date Check/Date
Name:Checking and Approval of the execution
Check the OQ results and original data, then form the ultimate conclusion of the OQ:
PASS □ FAIL □
If there’s still unsolved deviations, please fill down the following content:
Qualify if these unsolved deviations may influence the ultimate conclusion of the OQ.
YES □ NO □
Note:
Executed by
Signature Signature
Checked by
Signature Signature
Checked by
Signature Signature
AppendixⅠ: OQ results evaluation and suggestion
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Operational Qualification Protocol for HZD1500 Bin Blender Version:V01
OQ Result Evaluation and Suggestion
1. Purpose
This is to set the evaluation of the HZD1500 Bin Blender, and to conclude if the activities of OQ
meet equipment requirements, and if the Equipment qualification can be concluded and
suggested.
2. Scope
Operational Qualification of the HZD1500 Bin Blender manufactured by SAINTYCO
installed in Room , ID No.
The contents of this validation document refer to the equipment, testing steps,
specifications, documentation. This information will be used to ensure that the
blender has been installed, operated and run according to the user’s design
specifications and company’s requirements.
This document is compiled by SAINTYCO, and then the related approval signature,
supporting documents and other documentation will be included. Any supporting
datum and documentation shall be attached to the inspection report.
3. Summary
The validation of this equipment activities have been done according to the procedure
requirements of the Company (Management regulations of equipment validation), the
validation group proceeds according to the validation protocol of the HZD1500 Bin Blender.
The protocol should have the entire OQ validated and results of the checking listed. By the
validation process, the checking and auditing of the reports and deviations reports, qualify that
the protocol, during the implementation process, has no modification, is real and complete and
accords with requirements of the protocol.
The validation group, after has discussed, approves the Operational Qualification (OQ) of the
Bin Blender.
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Operational Qualification Protocol for HZD1500 Bin Blender Version:V01
4. Qualification record
No. Item Evaluation and analysis
1
OQR1:
PASS□ FAIL□ N/A□
2
OQR2:
PASS□ FAIL□ N/A□
3
OQR3:
PASS□ FAIL□ N/A□
4
OQR4:
PASS□ FAIL□ N/A□
5
OQR5:
PASS□ FAIL□ N/A□
6
OQR6:
PASS□ FAIL□ N/A□
7
OQR7:
PASS□ FAIL□ N/A□
8
OQR8:
PASS□ FAIL□ N/A□
9
OQR9:
PASS□ FAIL□ N/A□
10
OQR10:
PASS□ FAIL□ N/A□
11
OQR11:
PASS□ FAIL□ N/A□
12
OQR12:
PASS□ FAIL□ N/A□
13
OQR13:
PASS□ FAIL□ N/A□
14
OQR14:
PASS□ FAIL□ N/A□
15
OQR15:
PASS□ FAIL□ N/A□
16
OQR16:
PASS□ FAIL□ N/A□
Conclusion
Activities of the Operational Qualification accord with the requirements of the
protocol, operation of the Bin Blender accords with standards of the equipment and
design, industrial manufacturing and GMP requirements. And can go to the next step
activities and equipment validation or equipment trial operation.
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Operational Qualification Protocol for HZD1500 Bin Blender Version:V01
5. Results evaluation and suggestions
The group, after has checked the content report of the equipment validation and has discussed,
approves that the Operational Qualification (OQ) of the equipment accords with the
requirements of the protocol, thus Performance Qualification (PQ) of the equipment can be
performed.
By the validation process, the checking and auditing of the reports and deviations reports,
qualify that contents related to the OQ of the protocol, during the implementation process,
have not been modified, records are real and complete. The members of the validation group,
after have discussed, declares unanimously that activities of the Operational Qualification
accord with the requirements of the protocol, operation of the Bin Blender accords with
standards of the equipment and design, blender system accords with industrial manufacturing
and GMP requirements. And can go to the next step activities and equipment validation or
equipment trial operation.
6. List of signatures of validation group members (Brief)
7. Signatures
Executed by _
Signature
Date
(dd/mm/yyyy)
Checked by ____________________________ __________________
Signature
Date
(dd/mm/yyyy)
Checked by ____________________________ __________________
Signature
Date
(dd/mm/yyyy)
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Operational Qualification Protocol for HZD1500 Bin Blender Version:V01
AC Alternating current
A Ampere
V Volt
Hz Hertz
PLC Programmable Logic Controller
ºC Degrees Celsius
DQ Design Qualification
IQ Installation Qualification
OQ Operational Qualification
PQ Performance Qualification
FAT Factory Acceptance Test
SAT Site Acceptance Test
DQR Design Qualification Report
IQR Installation Qualification Record
OQR Operational Qualification Record
PQR Performance Qualification Record
DR Deviation Report
N/A Not Applicable
SOP Standard Operating Procedure
RSD Relative Standard Deviation