IQ、OQ、PQ- RV022002

Protocol Number:
S.K PHARMA MACHINERY PVT LTD Revision:
S.K PHARMA MACHINERY PVT LTD
Equipment Validation file

（Installation Qualification、Operation Qualification、Performance Qualification)
Device Name：Liquid Filling and Sealing Machine
Device Model：NALF-100
Name Code
Liquid Filling and Sealing

Machine（IQ/OQ/PQ)validation plan
Protocol Number:
Catalogue
1.Validation Protocol Approval.........................................................................................3

2. Outline.............................................................................................................................4
3. Purpose............................................................................................................................4
4. SCOPE............................................................................................................................4
5.Obligation........................................................................................................................4
7. Intallation Qualification（IQ）...................................................................................5
8. Operation Qualification（OQ）..................................................................................6
9. Performance Qualification（PQ）..............................................................................8
10. Review of verification results and verification conclusions.....................................9
11. File revisions and Historical alteration......................................................................9
12. Affix：...........................................................................................................................9
12.1.Training Record.......................................................................................................11
12.2.Installation Qualification records...........................................................................12
12.3.Operation Qualification records.............................................................................18
12.4.Performance Qualification records........................................................................25
Protocol Number:
1．Validation Protocol Approval

Issued by
Signature Date
Drifting Department
Equipment Engineering
Department
Reviewed by
Signature Date
Audit Department
Quality Management
Department
Production Technology
Department
Device Director
Authorized by
Approval by Signature Date
Qualified Person
Protocol Number:
2. Outline
2.1.Basic information
liquid filling and sealing
Name Model NALF-100
machine
Code Manufacturer SK Pharma
Date Installation date
Installation site Production (GPL)
2.2. Device System Description
Device Structure：It is mainly composed of filling part and capping part.
Device Features ： 2 straight lines were filled 1 time, 4 station bottle feed,
electromagnetic oscillating stoppers, cylinder stoppers, electromagnetic oscillating stoppers,
automatic stoppers, three knife stoppers.
2.3. Main Technical Parameters
Output: 4500-6000 bottles/hour
Applicable bottle: 60ml/100 ml bottle
Loading accuracy: ±2%
Sealing rate: ≥98%
Power source: 380V50Hz three-phase four-wire system
Power rate: 2 Kw
Dimensions: 2330x1230x1900mm
Protocol Number:
3. Purpose
Through validation ， to make sure liquid filling and sealing machine install and
operate ， Its performance can meet the requirements of production process and production
scale, and the standard operating procedure can meet the requirements of production
operation.
4. SCOPE
This plan is applied to company filling workshop liquid filling and sealing machine
installation、operation and performance qualification’s validation.
5．Obligation
Equipment Engineering Department：The department is primarily responsible for
drafting the validation protocol and report, and were responsible for the conduct of this
protocol. Responsible for tracking all deviation defects that are rectified.
Production Technology Department：The Department is primarily responsible for the
protocol and the review of reports. Is responsible for installation commissioning process
of coordination equipment and is primarily involved in performance confirmation
validation.
Quality Management Department：The Department is primarily responsible for the
review of validation protocols and validation reports. Responsible for monitoring and
inspection of the validation process and for making handling comments on deviations.
Device Director：Review of the validation protocol and validation report.
Qualified Person：The qualified person is responsible for the final approval of the
protocol, deviations, and reports.
6．Training
Before the implementation of the program, personnel involved in the implementation of the
program shall be trained to ensure the smooth implementation of the program, and training
records shall be made, as shown in appendix 6.1.
Protocol Number:
Installation Qualification（IQ）
7. Installation Qualification（IQ）
7.1 Confirmation of equipment data file
After unpacking and acceptance of the equipment, establish equipment files, collect and sort
out the operation instructions of the equipment, archive and save them, check and confirm
whether the materials are complete and stored correctly. The evaluation table of inspection
results is shown in appendix 7.1 All technical documents related to the equipment, including
host instructions and pass through, auxiliary instructions, mold maintenance instructions,
instructions or specification sheets for major components, etc.
7.2 Public works confirmation
Public works meet the requirements, including water, electricity, steam, etc. Actual measured
data, such as voltage, frequency, etc., should be recorded. The inspection and confirmation
form is shown in appendix 7.2.
7.3 Drawing confirmation
Drawing title, number, version number and date and the location where the drawing is saved.
The approved drawings or as-built drawings accurately represent the installed system and
discrepancies, if any, have been noted on the drawings. The inspection and confirmation form
is shown in appendix 7.3.
7.4 Spare parts list and tooling
List all equipment molds/replacement parts purchased and in place. The inspection and
confirmation form is shown in appendix 7.4
7.5 Maintenance plan confirmation
A detailed maintenance plan has been obtained from the equipment supplier. Including
maintenance of main engine, various parts, auxiliary machines and molds. The inspection and
confirmation form is shown in appendix 7.5
7.6 Construction materials
Product contact surface verification checks the material certification of construction
materials and product contact surfaces,you need to ensure all the constructions materials meet
the design requirements and all products contact surfaces meet technical requirements and do
not affect product quality and safety. The inspection and confirmation form is shown in
appendix 7.8
Protocol Number:
7.7 Brief summary in Installation Qualification

For installation confirmation, if there is any deviation, you can attach the deviation report
form to appendix 6.12, and make a description list of the deviation; Finally, the whole process
of installation confirmation is evaluated and suggested. The installation confirmation
summary is shown in appendix 6.12
Operation Qualification（OQ）
8.1 Preparations for Operation Qualification

8.1.1 Work confirmation in Installation Qualification
The IQ work has been successfully completed, and if there are any deviations, it has been
satisfactorily resolved before continuing with the OQ work. The inspection and confirmation
form is shown in appendix 8.1.1.
8.1.2 Calibration and verification of equipment and instruments
Confirm that the instruments of all systems confirmed in the IQ section are still within the
validity period of calibration when performing OQ work. The inspection and confirmation
table is shown in appendix 8.1.2.
8.1.3 Test instrument calibration
All measurement meters used in performing OQ are listed, defined, and classified according
to calibration management procedures. All measuring meters have been calibrated according
to calibration management procedures. The reference standards used for calibration are
traceable to national standards., The inspection and confirmation forms are shown in appendix
8.1.3.
8.1.4 The relate SOP and training confirmation
Sops for operation, cleaning and maintenance are at least in draft status. Record all relevant
Sops, including SOP numbers, names, inspection and validation forms in appendix 8.1.4.
8.2 Safety device/alarm device/interlock device confirmation
Verify that all safety equipment, alarms, and interlocks associated with the system are
functioning properly. If a test is likely to pose a hazard to personnel or machinery, it should be
noted in the OQ protocol that the said inspection, The inspection and confirmation forms are
shown in appendix 8.2.
Protocol Number:
8.3 Restart confirmation after power off

After a power outage, the machine does not automatically resume operation until the operator
takes action. If there is a data protection function, it should be activated, and the check and
confirmation table is shown in the attached table 8.3.
8.4 Basic operations confirmation
Manual operation confirm the basic operation of the test machine by button. If it is to use
Switching for control, most of the functions of Controller should be tested, and the inspection
and confirmation forms are shown in appendix 8.5.
8.5 Confirmation in software version
Confirm the software version of the system, and confirm that only authorized personnel can
change the key parameters. The check and confirmation table is shown in appendix 8.5.
8.6 Speed confirmation
At the upper and lower speed limits of the turntable and forced feeding device, the difference
between the actual speed and the set value should not exceed ±20%. See attached table 8.7 for
the inspection and confirmation table 8.6.
8.7 PLC compliance confirmation
Audit the supplier's PLC control system design, construction procedures and test results, and
attach the audit report to the verification record. I/O test report review. The inspection and
confirmation form is shown in appendix 8.7.
8.8 Idling operation confirmation
Verify that the tablet press is capable of idling under stable conditions for extended periods of
time. See below for speed setting. The temperature rise on the surface of the main motor and
reducer should be measured, and the inspection and confirmation table is shown in appendix
8.9 Brief summary in Operation Qualification
If there is a deviation in the operation confirmation, attach the deviation report form to the
appendix 8.10, and describe and list the deviation; make a summary evaluation and suggestion
for the whole process of the operation confirmation. The run confirmation summary is shown
in appendix 8.9.
Protocol Number:
Performance Qualification (PQ)
9.Preparation before performance qualification
9.1. IQ and OQ confirmation

Both IQ and OQ have been completed before the PQ, and any deviations have been resolved.
The inspection and confirmation table is shown in appendix 9.1.1.
9.1.2 Meter and Calibration Confirmation
Confirm that the instruments of all systems confirmed in the IQ and OQ sections are still
within the validity period of calibration when performing PQ work. See the appendix 9.1.2 for
the inspection and confirmation table.
9.1.3 Measuring instrument calibration confirmation
List, define and categorize all measuring instruments used in performing PQ according to the
Calibration Management Procedure. All measuring instruments have been calibrated
according to the calibration management procedure. The reference standard used for
calibration can be traced back to the national standard, and the inspection and confirmation
table is shown in the attached table 9.1.3.
9.2 Items and methods of performance verification
9.2.1 Test material: liquid, see Table 9.2.1 for the test material information.
9.2.2 Commissioning time: According to the common production speed of 30-60 bottles/min
and the maximum design speed of the equipment of 30-60 bottles/min, the two different
speeds will be run under continuous load for 1 hour respectively. Running speed: The test is
carried out at the usual speed of 30 bottles/min and the maximum speed of 60bottles/min;
Capacity range: 60ml/100ml
See the appendix 9.2.2 for equipment status during equipment performance confirmation.
9.2.3 Sampling inspection confirmation
During the 1-hour operation of the equipment performance confirmation, the loading and
capping detection operations are carried out:
5 minutes after the filling and sealing machine was started, the first sampling of filling and
capping detection was started. After that, samples were taken every 30 minutes, and 10 bottles
were randomly sampled each time. The test results are shown in appendix 9.2.3-1,2.
Protocol Number:
10 minutes after starting the filling and sealing machine, the first sampling of filling and
capping detection was started. After that, samples were taken every 30 minutes, and 10 bottles
were randomly sampled each time. The test results are shown in appendix 9.2.3-3,4.
15 minutes after starting the filling and sealing machine, the first sampling for the time limit
of tablet disintegration was started, and after that, samples were taken every 30 minutes, and 6
bottles were randomly sampled each time. The test results are shown in appendix 9.2.3-5,6.
9.3 Confirmation in Performance Qualification
If there is any deviation in Performance Qualification confirmation, attach the deviation report
form to Schedule 9.3 and make a description list of the deviation; Finally, the whole process
of operation verification is summarized, evaluated and suggested. A summary of performance
validation is provided in appendix 9.3.
10.Review of verification results and verification conclusions

The verification leading group comprehensively reviewed the results, made the verification
conclusion, issued the verification certificate, and determined the revalidation cycle of the
liquid potting machine equipment. The review of the validation results shall include:
·Verify the pilot projects whether they are omitted.
·Is there any modification to the verification scheme during the verification implementation?
Amendment reason, basis and whether it was approved?
· Verify whether the records are complete?
·Whether the verification test results meet the standard requirements? Are the deviations and
the description of the deviations reasonable? Is further supplemental testing required?
11. File revisions and Historical alteration
In the concrete implementation process，if there is something wrong with this plan, you
can make corresponding changes to this plan, but any changes to this plan and any content in
its annexes must go through the established change procedures, and can only be modified and
approved after being reviewed and approved by the relevant departments implement.
Protocol Number:
Version Execution Brief description of content after revising and modifying

Number Date
12. Appendix：
Validation result record：
12.1 Training Records
12.2.Installation Qualification Records
12.3 Operation Qualification Records
12.4 Performance Qualification Records
Appendix：
《Deviation report form》
《List of deviations 》
……
Protocol Number:
12.1 Training Records
Appendix 6.1 Training Record Table
Name
Time
No. Name No. Name No. Name
1. 2. 3.
4. 5. 6.
7. 8. 9.
10. 11. 12.
13. 14. 15.
16. 17. 18.
19. 20. 21.
22. 23. 24.
25. 26. 27.
28. 29. 30.

Protocol Number:
12.2 Installation Qualification Records
Appendix 7.1 Document Checklist

No. Name Number Repository Result
6
Protocol Number:
Appendix 7.2 Operation Qualification Records
No. Project Requirements Result
1 Installation site Liquid Filling Line Installation
Install in place according to design

2 Machine in place
drawing
Leave sufficient space around the
3 Installation space machine for operation and
maintenance
4 Installation mode Shockproof pad installation
Levelness
5 Horizontal meter proofreading
There was no loosening or detachment
6 Components
of each mechanical component
Electrically- All Controlling components and
7
Controlled Box circuits are well connected
Auxiliary
8
facilities
The temperature
Temperature: 18℃ ~ 26℃; Relative
9 and humidity of
humidity: 45% to 65%
the environment.
10 Air cleanliness Clean grade: 1,000,000
Appearance
11 complete，no defect
requirements
The outer surface
12 Flat and smooth, no obvious damage
of the machine
Complete fittings, tight solid without
13 Parts
defect
Control regulating
14 Clear usage and clear labeling
mechanism
Examiner： Examining Date:
Reviewer： Reviewing Date:

Protocol Number:
Appendix 7.3 Drawings confirmation

No
Name Code Version Date Repository
.
1
Examiner Examining Date:
Reviewer： Reviewing Date：
Appendix 7.4 Spare parts list and molds
No. Name Quantity Repository Result
Examiner： Examining Date：
Appendix 7.5 Device maintenance plan confirmation

Protocol Number:
No. Maintenance Projects Period Result
Appendix 7.6 Material checklist of main components of the device
No. Projects Material requirements Result

Main
Cast iron HT250 (nickel and
1 transmission
phosphorus plated)
parts
2 Table panel Stainless steel (1Cr18Ni9Ti)
Plug feeding
3 Stainless steel （1Cr18Ni9Ti）
cap screw
4 Protractor Cast Iron HT250
Conveyor
5 Glass-reinforced plastics
Belt
6 Panel Stainless steel（1Cr18Ni9Ti）

Protocol Number:
Appendix 7.7 Brief summary in Installation Qualification

Deviation：None
Suggestion：None
Evaluation：Initial runs were in good condition.
Evaluator： Date：
Protocol Number:
12.3 Run confirmation record
Appendix 8.1.1 IQ work confirmation
No. Checking Projects Requirements Result
Install and verify IQ-

1
Finished
All deviations are

Install and verify IQ-
closed, and if they
2
are not closed, there
Deviated
will be no impact on
operation
Examiner: Examining Date：
Reviewer : Reviewing Date：
Appendix 8.1.2~3 Calibration confirmation of equipment and test instruments

Expiry
No. Code Name Scale Type Result
Date
1

Protocol Number:
Appendix 8.1.4 The relate SOP and training confirmation
No. Name Code Repository Result

Standard Operating
1 Procedure for Liquid filling See appendix
and sealing Machine (Draft)
Maintenance Procedures for
2 Liquid filling and sealing See appendix
Machine (Draft)
Standard Operating
Procedure for Cleaning and
3 See appendix
Hygiene of Liquid filling
and sealing Machine (Draft)
4
Appendix 8.2 Safety device/alarm device/interlock device confirmation
No. Safety protection sites Requirements Result

Protocol Number:
Appendix 8.3 Restart confirmation after power off

Protocol Number:
Appendix 8.4 Basic operations confirmation
NO. Description Requirements Result
1 Main power switch The power indicator is on or off Normal
2 The power switch The power indicator is on or off Normal
Turn the speed

3 The tachometer shows the speed Normal
adjustment button
Bottle Filling Weight
4
Adjustment
Filling Sensor
5
alignment
6 Bottle Positioning
7 Sealing Jaw Setting
8 Inverter Check

Protocol Number:
Appendix 8.5 Confirmation in software version
Appendix 8.6 Check list for speed confirmation and idling operation confirmation
No. Projects Requirements Result
Appendix 8.7 PLC compliance confirmation

Protocol Number:
No. Projects Requirement Result

Protocol Number:
Appendix 8.9 Idling operation confirmation

Deviation：
After testing, the loading deviation was less than 2%, the qualified rate reached 98% and
the rolling cover rate reached 98% after the upper plug was siliconized.
Suggestion：
Glue stoppers must be siliconized prior to production or glass bottle manufacturers are
advised to place an arc angle at the mouth of the bottle.
Evaluation: able to put into production.
Evaluator： Date:
Protocol Number:
12.4 Performance Qualification confirmation
Appendix 9.1.1 IQ、OQ work confirmation
1 IQ、OQ Validation is finished Normal

All deviations are
closed or, although
not closed, assessed
2 IQ、OQ deviation Normal
to have no impact on
the operational
validation
Appendix 9.1.2~3 Calibration confirmation of equipment and test instruments
Expiry
No.1 Code Name Scale Type Result
Date
1

Protocol Number:
Appendix 9.2.1 Test material information sheet

Conformity Inspection
No. Name Batch Number Quantity
of quality report number
1

Protocol Number:
Appendix 9.2.2 Checklist of equipment running status during performance verification
NO. Projects Requirements Result Notes

Protocol Number:
Appendix 9.2.3—1 Record for differential loading detection

Liquid
Detection Liquid
Speed 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Syrup Vol
time Syrup Vol
difference
5
minutes
35
minutes
65
minutes
95
30-60 minutes
bottle/ 125
min minutes
155
minutes
Conclusion：

Protocol Number:
Appendix 9.2.3—2 Record for differential loading detection

Liquid
Detection Liquid
Speed 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Syrup Vol
time Syrup Vol
difference
5
minutes
35
minutes
65
minutes
95
minutes
30-
125
60Bott
minutes
le/min
155
minutes
Conclusion：

Protocol Number:
Appendix 9.3 Brief summary in Performance Qualification

Deviation:
After testing, the deviation of each index meets the requirements of the contract and
industry standards.
Suggestion:
Customer manufacturing when the stopper needs silicification treatment or it is
recommended that bottle manufacturer put arc angle at the bottle mouth.
Evaluation:
Meet the requirements
Evaluator Date:

IQ、OQ、PQ- RV022002

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

IQ、OQ、PQ- RV022002

Uploaded by

Copyright:

Available Formats

Protocol Number:

S.K PHARMA MACHINERY PVT LTD Revision:

S.K PHARMA MACHINERY PVT LTD

Equipment Validation file

Liquid Filling and Sealing

S.K PHARMA MACHINERY PVT LTD Revision:

1.Validation Protocol Approval.........................................................................................3

S.K PHARMA MACHINERY PVT LTD Revision:

1．Validation Protocol Approval

S.K PHARMA MACHINERY PVT LTD Revision:

Output: 4500-6000 bottles/hour

Applicable bottle: 60ml/100 ml bottle

Loading accuracy: ±2%

Sealing rate: ≥98%

Power source: 380V50Hz three-phase four-wire system

S.K PHARMA MACHINERY PVT LTD Revision:

S.K PHARMA MACHINERY PVT LTD Revision:

S.K PHARMA MACHINERY PVT LTD Revision:

7.7 Brief summary in Installation Qualification

8.1 Preparations for Operation Qualification

S.K PHARMA MACHINERY PVT LTD Revision:

8.3 Restart confirmation after power off

S.K PHARMA MACHINERY PVT LTD Revision:

Performance Qualification (PQ)

9.Preparation before performance qualification

9.1. IQ and OQ confirmation

S.K PHARMA MACHINERY PVT LTD Revision:

10.Review of verification results and verification conclusions

S.K PHARMA MACHINERY PVT LTD Revision:

Version Execution Brief description of content after revising and modifying

S.K PHARMA MACHINERY PVT LTD Revision:

12.1 Training Records

Appendix 6.1 Training Record Table

No. Name No. Name No. Name

10. 11. 12.

13. 14. 15.

16. 17. 18.

19. 20. 21.

22. 23. 24.

25. 26. 27.

28. 29. 30.

S.K PHARMA MACHINERY PVT LTD Revision:

12.2 Installation Qualification Records

Appendix 7.1 Document Checklist

S.K PHARMA MACHINERY PVT LTD Revision:

Appendix 7.2 Operation Qualification Records

No. Project Requirements Result

1 Installation site Liquid Filling Line Installation

Install in place according to design

Reviewer： Reviewing Date:

S.K PHARMA MACHINERY PVT LTD Revision:

Appendix 7.3 Drawings confirmation

Examiner Examining Date:

Reviewer： Reviewing Date：

Appendix 7.4 Spare parts list and molds

No. Name Quantity Repository Result

Examiner： Examining Date：

Reviewer： Reviewing Date：

Appendix 7.5 Device maintenance plan confirmation

S.K PHARMA MACHINERY PVT LTD Revision:

No. Maintenance Projects Period Result

Examiner： Examining Date：

Reviewer： Reviewing Date：

Appendix 7.6 Material checklist of main components of the device