PQ Protocol of Strip

Equipment ID: PDC/SP/001
Protocol No: PQP/SP/001/00

TITLE: PERFORMANCE
Revision No. QUALIFICATION PROTOCOL FOR Model No.
STRIP PACKING MACHINE
Supersedes No. NIL Effective Date:-
PERFORMANCE QUALIFICATION
PROTOCOL FOR STRIP PACKING
MACHINE
:
EQUIPMENT NAME
:
EQUIPMENT ID.
:
MODEL NO.
:
PQ PROTOCOL NUMBER
:
EFFECTIVE DATE
Page 1 of 18
Annexure No. QA-048/A05/00
Protocol No: PQP/SP/001/00 TITLE: PERFORMANCE Equipment ID:- PDC/SP/001
QUALIFICATION PROTOCOL Model No.
Revision No.
FOR STRIP PACKING MACHINE
Supersedes No. NIL
PROTOCOL CONTENTS
S. No. TITLE PAGE No.

1.0 PROTOCOL APPROVAL 3
2.0 OBJECTIVE 4
3.0 SCOPE 4
4.0 RESPONSIBILITY 4
5.0 EQUIPMENT DETAILS 5
6.0 MACHINE DESCRIPTION 5-6
7.0 REASON FOR QUALIFICATION 7
8.0 SITE OF STUDY 7
9.0 FREQUENCY OF QUALIFICATION 7
10.0 NON COMPLIANCE 7
11.0 PRE-QUALIFICATION REQUIREMENTS 7-8
12.0 PERFORMANCE QUALIFICATION PROCEDURE 9
13.0 TESTS TO BE PERFORMED 9-16
14.0 CHECKLIST OF ALL TESTS AND CHECKS 17
15.0 REFERENCES 18
16.0 DOCUMENTS TO BE ATTACHED 18
17.0 DEVIATION FROM PRE-DEFINED SPECIFICATION, IF ANY 18
18.0 CHANGE CONTROL , IF ANY 18

19.0 REVIEW (INCLUSIVE OF FOLLOW UP ACTION, IF ANY ) 18
20.0 CONCLUSION 18
21.0 RECOMMENDATION 18
22.0 ABBREVIATIONS 19
Page 2 of 18
TITLE: PERFORMANCE
1.0 PROTOCOL APPROVAL :
INITIATED BY:
DESIGNATION NAME SIGNATURE DATE
OFFICER/EXECUTIVE - QA
REVIEWED BY:
HEAD -PRODUCTION
HEAD -ENGINEERING
APPROVED BY:
HEAD - QA
Page 3 of 18
Revision No.
Supersedes No. NIL
2.0 OBJECTIVE:
 To provide documented evidence that the Equipment is performing as per the parameter defined
in Operational Qualification and that it gives result as per the predetermined acceptance criteria.
 To demonstrate that the system will operate reproducibly and consistently within its operating
range.
 To confirm the suitability of the Standard Operating Procedures for all routine activities
associated with the system.
 The Document also provides the observed and obtained values indicating compliance to the PQ
Report.
3.0 SCOPE:
 The Protocol covers all aspects of Performance Qualification for the Strip Packing
Machine at GMH Laboratories Bhatoli Kalan, Baddi (H.P.)
 This Protocol will define the methods and documentation used to qualify the Strip Packing
Machine at GMH Laboratories Bhatoli Kalan, Baddi (H.P.)

4.0 RESPONSIBILITY:
The Validation Group, comprising of a representative from each of the following Departments, shall
be responsible for the overall compliance of this Report:
DEPARTMENTS RESPONSIBILITIES
 Preparation, Review, Approval and Compilation of the

Performance Qualification Report.
 Protocol Training
Quality Assurance
 Co-ordination with Quality Control, Production and Engineering
to carryout Performance Qualification Activity
 Monitoring of Performance Qualification.
 Review of Protocol.
Engineering
 To co-ordinate and support Performance Qualification Activity.
Page 4 of 18
TITLE: PERFORMANCE
 Review of Report.
Production
 To co-ordinate and support Performance Qualification Activity.
5.0 EQUIPMENT DETAILS:
Equipment Name
Equipment ID.
Manufacturer’s Name
Supplier’s Name
Model
Equipment No.
Location of Installation
6.0 MACHINE DESCRIPTION:

The strip Packing Machine is a robust, flat-forming-and-flat- sealing, intermittent motion STRIP pack
machine for the packaging of pharmaceutical products like tablets and capsules.
All main stations are Servo controlled, with the exception of the high speed section (perforation,
embossing and STRIP pack punch-out section).
In operation, the base-film is intermittently drawn from either of the two reel stocks and fed to the
STRIP forming station.
Base film unwind is motorized. It ensures drawing of the film (into the preheaters), without undue
tension or jerks, which would otherwise cause lengthwise stretching and widthwise shrinking of the
film.
The thermoform film is heated by platen heaters, just before the STRIP forming station and then (in
the next cycle) advanced into the dies of the STRIP forming station. The top and bottom preheaters
have individual temperature adjustment. Preheaters can open wide at machine stop to avoid
overheating of base film, and open just sufficiently between cycles to allow for index.
Page 5 of 18
Revision No.
Supersedes No. NIL
In the forming station, thermoform STRIPs are formed with the help of
 compressed air alone, or
 plug-assisted thermoforming, or
 cold forming.
Preheaters are switched off while cold forming. Changeover between modes is simply by doing the
appropriate selection on the HMI.
The formed web is then led over a guide-track. Next, the product is filled into the STRIP cavities.
Then, the web enters the sealing unit along with the bidding material. The lid foil reel is also mounted
on a mandrel which is motorized, and a dancing arm switches the motor on or off to deliver additional
foil, as and when needed. Lidding material is pulled in to the sealing station, where it is sealed with the
base-web, thus enclosing the product hermetically. The sealed web is cooled immediately on exit from
the sealing station by a cooling plate.
The filled, sealed and cooled web is gripped and pulled through the set index (advance) value by a
gripped indexing mechanism. The index value is settable on the HMI.
The sealed web, then, moves over a dancer arm, into the high speed section of the machine, where it is
independently advanced intermittently by a servo-driven punch index roller. Its index frequency is
determined by the “number of repeats per frame" and its index value (in degrees) is determined by the
“punch index slots”.
Embossing, perforation and punching are carried out and the packs are thus separated from the web.
At the same time, trim is cut and dropped into the trim chute. Packs are picked up by an oscillating
pack-pickup assembly, off the punching tool. These are transported up to the outfeed conveyor or
chute if they are good, or are dropped earlier into a reject chute (this is possible if the machine is
equipeed with an optional non-fill detect camera).
Electrical supply to the machine is 415Vac, 3-Phase/N/E, 50Hz (nominal). There are two separate
supply points given in the machine, viz. Electrical supply for the Heaters & Electrical supply for the
rest of the machine components. The scheme is to provide UPS supply to the machine (supplying
Control circuit, Servo amplifiers, VFDs, 24Vdc SMPS & PLf only) & raw Mains 3-Phase supply for
the heating circuit. Each of these supply input points are indicated with respective stickers that indicate
UPS SUPPLY & HEATER SUPPLY.
The Mains supply to the UPS is interlocked in a way that a digital input in the machine controller rack,
changes state whenever this supply to UPS, falls below certain value that is preset within the UPS unit.
In cnse of Mains supply failure, the machine HMI indicates an alarm as such & allows the machine
cycle to run (in cnse the machine is running in cycle) till a settable count (in HMI).
Page 6 of 18
TITLE: PERFORMANCE
Optional features include
 splice detection for base film and lid foil

 pin hole detector for coldform films
 vision system for product non-fill
 print mark scanning and correction, and
 different types of conveyors for product removal from the machine.

If the machine is equipped with print registration control, the correction is done on the base film
advance during indexing to maintain print mark registration.
7.0 REASON FOR QUALIFICATION:
After completion of the Operation Qualification of the Equipments, it is imperative to perform

the Performance Qualification. The study will establish that the parameters are followed, critical
variables are under control and the quality of the output is, as desired.
8.0 SITE OF STUDY:
 Tablet Primary Packing Area at GMH Laboratories Bhatoli Kalan, Baddi (H.P.)
9.0 FREQUENCY OF QUALIFICATION:
 Once in Every Five Years.

 After any major breakdown or after major modification.
 After Change of Location
10.0 NON COMPLIANCE:
 In case of any deviation observed during PQ, inform to Head QA for necessary action.
 Document the deviation detail in observed deviation section.
 The Head QA will study the impact of deviation. If deviation is acceptable and it does not
have an impact on operation as well as on performance of the machine, prepare final conclusion.
11.0 PRE-QUALIFICATION REQUIREMENTS:
The results of any tests should meet the limits and acceptance criteria specified in the test documents.
Any deviations or issues should be rectified and documented prior to PQ commencing
Page 7 of 18
Revision No.
Supersedes No. NIL
11.1 SYSTEM PRE-REQUISITES:
Verify that the DQ/IQ/OQ of the Strip Packing Machine has

been executed and approved.
Verify that the Operating and Cleaning SOP of the strip Packing Machine
has been prepared.
CHECKED BY VERIFIED BY
DOCUMENT/ COMPLETED
S. No. DOCUMENT NAME (PRODUCTION) (QA)
SOP No. (YES / NO)
(SIGN& DATE) (SIGN/DATE)
1. DQ Protocol
2. IQ Protocol
3. OQ Protocol
Operating Procedure
4.
SOP
Cleaning Procedure
5.
SOP
11.2 TEST EQUIPMENT CALIBRATION:
Verify that all critical instruments associated with the system will be in a calibrated state. Review the
calibration status for the test equipment to be utilised and record the calibration due dates in the table
below.
EQUIPMENT / EQUIPMENT /
CALIBRATION CALIBRATION OBSERVED BY
INSTRUMENTS INSTRUMENTS
DONE ON DUE ON SIGN & DATE
NAME ID.
Page 8 of 18
TITLE: PERFORMANCE
12.0 PERFORMANCE QUALIFICATION PROCEDURE:
SELECTION OF BATCH
Sr. No Name of the Product Batch Number Batch Size Mfg. Exp.
Checked By: Verified By:
Materials:
Ensure that, below listed; required materials are available before the performance qualification
activities are carried out.
Material Availability
Batch Checked Verified
Date Name of Product Aluminium
Number Tablets Stereos By By
foil
13.0 TEST’S TO BE PERFORMED:
13.1 PRODUCT FEEDING CHECK:
Test Method of Test Acceptance Criteria

Product Check the product feeding visually from
There should not be any jam and breakage of
feeding hopper to Feeder Box then to STRIP
Tablet during continuous feeding.
check. pockets.
Observation: Record the test observation in following table.
Page 9 of 18
Revision No.
Supersedes No. NIL
Pass / Checked Verified

Date Name of Product Batch No. Observation
Fail By By
13.2 STRIP SEALING CHECK:

Set the machine at required sealing temperature Sealing temperature should be in the
STRIP
and check the sealing performance by checking range of 110ºC-140ºC and there should
Sealing
leak test of 100 sealed STRIPs at initial, middle not be any pocket leakage, colour
Check.
and end of operation and after any foil change changes (lifting) on the STRIPs.

Observation
STRIP Pass / Checked Verified
Date Name of Product Batch No. Leak
Sealing Fail By By
Test
Temperature
13.3 OVER PRINTING QUALITY CHECK:

Each and every impression on STRIPs which
Collect 100 STRIPs after cutting and check
Over Printing coincides the total number of stereos affixed
the over printing / embossing appearance
Quality on the Batch embossing/Batch printing unit
visually at initial, middle and end of
Check should be readable and as per text matter of
operation.
stereo fitted over there.

Observation
STRIP Coding Quality Pass / Checked Verified
Date Name of Product Batch No.
(should be Clear, Fail By By
Legible, Correct etc.)
Page 10 of 18
TITLE: PERFORMANCE
13.4 PUNCHING/ CUTTING CHECK:

Collect 100 STRIPs after cutting and Check Horizontal /Vertical cutting should be
Punching/ Cutting Horizontal /Vertical cutting of STRIP at initial, satisfactory, distance from edge should
Check. middle and end of operation coming out from be equal and no jamming should occur in
punching tool . punching tool.

Observation
Name of No. of Horizontal/ Pass / Checked Verified
Date Batch No. Foil
Product STRIPs Vertical Fail By By
Shift
Cuttings
13.5 PHYSICAL APPEARANCE CHECK:

There should not be any damage or abnormal
Collect 100 STRIPs after cutting and
Physical printing over the STRIPs.
Check Physical appearance of STRIP
Appearance Knurling of the STRIPs should be OK.
visually at initial, middle and end of
Check. There should not be any pin holes, Broken,
operation.
chipped, empty pockets in the STRIPs.

Observation Pass
Name of Physical Checked Verified
Date Batch No. Empty /
Product Appearance Knurling By By
Pockets Fail
Page 11 of 18
Revision No.
Supersedes No. NIL
13.6 FOIL SHIFT CHECK:
Collect 100 STRIPs after cutting and Physically There should not be any abnormal
Foil Shift check the smooth flow of foils as per the speed of sifting of foils and cutting of the
machine. STRIPs should be proper.

Name of Pass / Checked Verified
Date Batch No. Observation
Product Fail By By
13.7 CHALLENGE TESTS:
Equipment / system should pass through the following challenge test or worse case scenario test to
check the performance of the equipment in the worse case condition.
13.7.1 SPEED PERFORMANCE-LOW SPEED: (30 CYCLES PER MINUTES)

Run the machine at low speed No empty pocket, No leak of pocket and
Speed performance
and collect STRIPs of consecutive clear over printing should be observed and
(Low Speed)
100 cuttings. output should match with set speed.
Observation: Record the test results in following table.

Observation at Low Speed.
Name of Batch 30 Cycles Per Minute Pass / Checked Verified
Date
Product No. Empty Leak Fail By By
Overprinting
Pockets Test
13.7.2 SPEED PERFORMANCE-HIGH SPEED: (70 CYCLES PER MINUTES)
Page 12 of 18
TITLE: PERFORMANCE
Run the machine at high speed and No empty pocket, No leak of pocket and
Speed Performance
collect STRIPs of consecutive 100 clear over printing should be observed and
(High Speed)
cuttings. out put should match with set speed.

Observation at High Speed.
Date
Overprinting
Pockets Test
13.7.3 SPEED PERFORMANCE-OPTIMUM SPEED: (50 CYCLES PER MINUTE)

Run the machine at optimum speed No empty pocket, No leak of pocket and
Speed Performance
and collect STRIPs of consecutive clear over printing should be observed and
(Optimum Speed)
100 cuttings. out put should match with set speed.

Observation at optimum Speed.
Date
Overprinting
Pockets Test
13.7.4 SEALING TEMPERATURE CHECK - 110 0C: (LOWER LIMIT)

Set the sealing temperature 110 0C and Sealing should be proper and No leakages
Sealing Temperature
collect STRIPs of consecutive 100 of STRIP and no color fading should be
110 0C
Cuttings. observed.

Observation at Set Temperature 1100C
Name of Batch Pass / Checked Verified
Date
Product No. Burn Leak Colour Fail By By
Foil Test Fading
Page 13 of 18
Revision No.
Supersedes No. NIL
13.7.5 SEALING TEMPERATURE CHECK - 140 0C: (HIGHER LIMIT)

Set the sealing temperature 140 0C and Sealing should be proper and No leakages
Sealing Temperature
collect STRIPs of consecutive 100 of STRIP and no color fading should be
140 0C
cuttings. observed.

Observation at Set Temperature 1500C
Name of Batch Pass / Checked Verified
Date
Product No. Burn Leak Colour Fail By By
Foil Test Fading
13.7.6 VIBRATION CHECKS:

Set the vibrator speed minimum and check the Smooth product flow and no empty pocket
Vibration feeding of tablets in STRIP pocket. should observed
checks
Set the vibrator speed maximum and check the Smooth product flow and no empty pocket
feeding of tablets in STRIP pocket. should observed
Observation: Record the test results in following table

Observation
Date Name of Product Batch No. Minimum Maximum Fail By By
Speed Speed
13.8 SAFETY FEATURES:

Emergency Stop Check
All safety features and alarm performance should be verified during the performance qualification
Page 14 of 18
TITLE: PERFORMANCE
and should be documented.

Press the emergency stop switch
Emergency Stop Check Machine should stop immediately.
during machine operation.

Fail By By
13.9 PIN HOLE DETECTION CHECK:
Pin hole detection performance should be verified during the performance qualification and should
be documented.
The pack having a pinhole is detected
by the pinhole Detector. On the MMI
screen the alarm displayed is:
PINHOLE DETECTED IN BASE
Using a pin, pierce a tiny traceable/ FOIL. Machine cycle is not
identifiable hole in the aluminium interrupted. Subsequently, the entire
Pin Hole Detection Check
base foil before the base foil enters corresponding repeat containing the
into forming station. defective pack is discharged into
Rejection chute by the pick-and-place
device at the punching tool along with
a repeat earlier & later to the defective
pack.

Fail By By
Page 15 of 18
Revision No.
Supersedes No. NIL
13.10 CHECKLIST OF ALL TESTS AND CHECKS:
This checklist is provided to ensure that all tests or checks required for this Protocol have been
executed. Physical and chemical characteristics consisting of following tests.
S.
TESTS OR CHECKS EXECUTED [Y/N] COMMENT
No.
1. Product Feeding Checking
2. Strip Sealing Check
3. Over Printing Quality Check
4. Punching / Cutting Check
5. Physical Appearance Check
6. Foil Shift Test
7. Speed Performance Test-Low Speed
8. Speed Performance Test-High Speed
9. Speed Performance Test-Optimum Speed
10. Sealing Temperature Check - 130˚C
11. Sealing Temperature Check - 150˚C
12. Vibration Check
13. Strip Formation Check
14. Emergency Stop Check
Checked By Verified By
(Production) Quality Assurance)
(Sign & Date) (Sign & Date)
Inference:______________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
Reviewed By:__________________
(Manager QA)
Page 16 of 18
TITLE: PERFORMANCE
Sign & Date

15.0 REFERENCES:
The Principle Reference is the following:
 Master Validation Plan.
 Schedule – M – “Good Manufacturing Practices and Requirements of Premises, Plant and

Equipment for Pharmaceutical Products.”
 WHO Essential Drugs and Medicines Policy, QA of Pharmaceuticals, Vol-2 Good Manufacturing
Practices and Inspection.
16.0 DOCUMENTS TO BE ATTACHED:
 Final SOPs
 Any Other Relevant Documents
17.0 DEVIATION FROM PRE-DEFINED SPECIFICATION, IF ANY:
18.0 CHANGE CONTROL, IF ANY:
19.0 REVIEW (INCLUSIVE OF FOLLOW UP ACTION, IF ANY) :
20.0 CONCLUSION:
21.0 RECOMMENDATION:
22.0 ABBREVIATIONS:
WHO : World Health Organization
FDA : Food and Drug Administration
CFR : Code of Federal Regulations
cGMP : Current Good Manufacturing Practices
QA : Quality Assurance
Page 17 of 18
Revision No.
Supersedes No. NIL
QC : Quality Control
IPQC : In-Process Quality Control
DQ : Design Qualification
IQ : Installation Qualification
OQ : Operational Qualification
PQ : Performance Qualification
SOP : Standard Operating Procedure
BPCR : Batch Production and Control Record
mg : Milligram
kg : kilogram
S. No. : Serial Number
Ltd : Limited
Page 18 of 18

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Equipment ID: PDC/SP/001

Protocol No: PQP/SP/001/00

S. No. TITLE PAGE No.

5.0 EQUIPMENT DETAILS 5

6.0 MACHINE DESCRIPTION 5-6

7.0 REASON FOR QUALIFICATION 7

8.0 SITE OF STUDY 7

9.0 FREQUENCY OF QUALIFICATION 7

10.0 NON COMPLIANCE 7

11.0 PRE-QUALIFICATION REQUIREMENTS 7-8

12.0 PERFORMANCE QUALIFICATION PROCEDURE 9

13.0 TESTS TO BE PERFORMED 9-16

14.0 CHECKLIST OF ALL TESTS AND CHECKS 17

16.0 DOCUMENTS TO BE ATTACHED 18

17.0 DEVIATION FROM PRE-DEFINED SPECIFICATION, IF ANY 18

18.0 CHANGE CONTROL , IF ANY 18

1.0 PROTOCOL APPROVAL :

DESIGNATION NAME SIGNATURE DATE

DESIGNATION NAME SIGNATURE DATE

DESIGNATION NAME SIGNATURE DATE

 Preparation, Review, Approval and Compilation of the

 Monitoring of Performance Qualification.

5.0 EQUIPMENT DETAILS:

6.0 MACHINE DESCRIPTION:

Optional features include

 splice detection for base film and lid foil

7.0 REASON FOR QUALIFICATION:

After completion of the Operation Qualification of the Equipments, it is imperative to perform

8.0 SITE OF STUDY:

9.0 FREQUENCY OF QUALIFICATION:

 Once in Every Five Years.

10.0 NON COMPLIANCE:

11.0 PRE-QUALIFICATION REQUIREMENTS:

11.1 SYSTEM PRE-REQUISITES:

Verify that the DQ/IQ/OQ of the Strip Packing Machine has

11.2 TEST EQUIPMENT CALIBRATION:

12.0 PERFORMANCE QUALIFICATION PROCEDURE:

Checked By: Verified By:

13.0 TEST’S TO BE PERFORMED:

13.1 PRODUCT FEEDING CHECK:

Test Method of Test Acceptance Criteria

Observation: Record the test observation in following table.

Pass / Checked Verified

13.2 STRIP SEALING CHECK:

Test Method of Test Acceptance Criteria

Observation: Record the test observation in following table.

13.3 OVER PRINTING QUALITY CHECK:

Test Method of Test Acceptance Criteria

Observation: Record the test observation in following table.

13.4 PUNCHING/ CUTTING CHECK:

Test Method of Test Acceptance Criteria

Observation: Record the test observation in following table.

13.5 PHYSICAL APPEARANCE CHECK:

Test Method of Test Acceptance Criteria

Observation: Record the test observation in following table.

13.6 FOIL SHIFT CHECK:

Test Method of Test Acceptance Criteria

Observation: Record the test observation in following table.

13.7 CHALLENGE TESTS:

13.7.1 SPEED PERFORMANCE-LOW SPEED: (30 CYCLES PER MINUTES)

Test Method of Test Acceptance Criteria

Observation: Record the test results in following table.

13.7.2 SPEED PERFORMANCE-HIGH SPEED: (70 CYCLES PER MINUTES)

Test Method of Test Acceptance Criteria