1 Purpose

The purpose of this Operational Qualification is to describe how, when, why and by whom the Operational Qualification
must be performed. The equipment will operate without any product nor capsule to check if everything works according
to the operating manual and the supplier information.
The final objective is to prove that each operation proceeds as per the design specification and the tolerances prescribed
in the supplier documents.
The next step, if the equipment is stated functional, will be to operate it with the product and capsules.

2 Scope
The scope of this qualification document is limited to the Operational Qualification of Model.
The qualification of support utilities is not within the scope of this qualification document. The equipment shall be used
for filling powder in capsules. The equipment shall operate under dust free environment and condition as per the GMP
requirements.

The description of the equipment is written in the table below:

Equip # Description Serial Number

EXXX Semi-automatic capsule filling machine ???

The Operational Qualification is part of the Validation Master Plan of company. It starts once the Installation
Qualification is completed and the IQ report is approved. It is prior to the Performance Qualification which can only
start once the OQ report is approved.

The results will be discussed at the end of this document. If the equipment complies with the specification, the
Operational Qualification will be approved. If the equipment do not comply, further actions will be taken by the Quality
Assurance and the Responsible Pharmacist.

3 Abbreviations
GMP Good Manufacturing Practice PQ Performance Qualification
DQ Design Qualification FRL Filter, Regulator and Lubricant
IQ Installation Qualification Rpm rotation per minute
OQ Operational Qualification SOP Standard Operating Procedure

4 Responsibility
- The production staff is responsible for performing the cleaning, visually inspection of the equipment and the
recording of the data.
- The Production Manager ensures that the cleaning is performed with trained staff, supervises the study
- The Validation team supervises the study, verifies the
- completion of the records and makes sure the protocol is followed, otherwise initiates and compiles the required
deviation(s).
- Quality Assurance reviews and approves the Operational Qualification.
- Responsible Pharmacist must review, approve and sign off the Operational Qualification.

5 Safety Precautions
- All safety requirements for Quality Control Laboratory and Production must be observed and implemented during
validation (see part 6).
- Refer to Material Safety Data Sheets (MSDS) for proper handling and disposal of the materials.

6 References
List references used:
- General safety precautions for chemical spills in Quality control Laboratory
- General safety precautions - classes of toxins
- General safety precautions - Fire safety
- General safety precautions - safety in the laboratory
- First Aid for chemical exposure
- Storage and handling of Toxic substances in Stores
- Cleaning procedure for production
- Cleaning procedure of equipment
- Tank Cleaning Validation Tests
APPROVAL BY:

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 Equipment Cleaning Validation: Microbial Control Issues, Destin A. LeBlanc, M.A., Cleaning Validation
Technologies. Journal of Validation Technology August 2002 Volume 8, Number 4

7 Procedure
7.1 General Considerations
The operation of the machine must be carried out and/or supervised by a trained person.
The operating manual must be available.
The check must be signed by a member of the Validation Team.
It is highly recommended that the staff members meant to operate the machine are present during the OQ.
Before starting, ensure that all the points

7.2 Documents required

Operating manual

7.3 Material required

Grease
Capsules (quantity, size) must decide if test done on several sizes or one.

7.4 Other
- Opening of the acrylic gate of the main reservoir of the capsule hopper: must be optimum
- Try the different change parts of the machine
- Try the minimum and maximum speed
- Appendix: plan of the machine with names of the parts and buttons

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 7.5 Documents required
Procedure Result to be observed State* Date** Operator Check
Operating manual N/A . C . NC . / /2016
Material certificate N/A . C . NC . / /2016

7.6Operational Qualification of the machine

Procedure Result to be observed State* Date** Operator Check
LOADING STATION
1. Switch ON the main supply N/A . C . NC . / /2016
2. Switch on the machine in manual mode The machine turns ON . C . NC . / /2016
3. Add grease to the gear and the gear shift: remove the
screw and open the bottom cover of the gearbox, apply N/A . C . NC . / /2016
grease to all gears.
4. Check the capsule release pin It is not loose . C . NC . / /2016
The magazine assembly starts moving up and down . C . NC . / /2016
5. Push IN the hand wheel located on the right hand side of
the machine and turn clockwise The motor rotation matches the direction of the arrow painted
. C . NC . / /2016
on the motor
No accident due to any misalignments . C . NC . / /2016
Loading table should not rub against cladding sheet . C . NC . / /2016
6. Check motions of all moving parts with the help of hand Free movement of magazine, horizontal and vertical supports
. C . NC . / /2016
wheel in their guides
Proper entry of blades in raceway at visual center . C . NC . / /2016
Blade contact at center of length of the capsule . C . NC . / /2016
7. Ensure proper seating of loading ring on loading table Properly seated . C . NC . / /2016
8. Ensure safety door lever is properly clamped Properly clamped . C . NC . / /2016
9. Turn the hand wheel and shift gears Smooth shifting of gears with levers ABC, XYZ . C . NC . / /2016
10. Switch on the machine in automatic mode N/A . C . NC . / /2016
11. Fit the safety guard of the loading station, press the Reset The loading cycle starts and stops after completing one
. C . NC . / /2016
(yellow) button, then press the Start (green) button rotation of the loading ring consisting of 60 indexing (counts)
12. Press again the Start button, and during the loading cycle The loading cycle starts after pressing the green button and
. C . NC . / /2016
press the Stop (Red) button stops after pressing the red button

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 Procedure Result to be observed State* Date** Operator Check
The loading cycle restarts and continue until completion of the
13. Press again the Start button . C . NC . / /2016
remaining strokes
14. There are 2 speeds for the auger. Try them and check the The speed increases of decreases proportionally to the
. C . NC . / /2016
speed of the auger change of speed
15. There are 9 speeds for the filling table. Try them and The speed increases of decreases proportionally to the
. C . NC . / /2016
check the speed of the filling table change of speed
POWDER FILLING
The gap between the proximity switch and body ring must be
. C . NC .
16. Place the body ring of the loading ring on the filling table. around 1 to 2mm / /2016
The LED of Proximity switch starts glowing . C . NC .
17. Ensure drug hopper swinging cylinder is clamped
Clamped properly . C . NC . / /2016
properly
18. Ensure no vertical play in auger shaft No vertical play . C . NC . / /2016
The hopper swings over the body ring place on the filling table . C . NC .
The auger starts rotating in clockwise direction . C . NC .
The auger actuates the proximity switch on the housing of the
. C . NC .
19. Press the powder table Start button (green) hopper, which makes the auger start rotating / /2016
The swivel hopper comes to extreme position of swivel (i.e.
. C . NC .
auger comes over the ring) and the filling table starts
As soon as one revolution is completed, the filling table and
. C . NC .
auger stops and the hopper swings back to its initial position.
The auger starts earlier when the proximity switch is closer to
20. If necessary, the starting of auger can be adjusted based . C . NC . / /2016
the powder hopper housing
on the position of proximity switch on the powder hopper
housing The auger starts later when the proximity switch is closer to
. C . NC . / /2016
the powder hopper housing
CLOSING STATION
21. Check the entry of closing table in rails Free entry of closing table in rails . C . NC . / /2016
Free movement of closing unit in guide rails . C . NC .
22. Check the movement of closing unit Stops at stopper . C . NC . / /2016
Free swinging of closing table . C . NC .
23. Assemble the body ring and cap ring of the loading ring
The body ring and cap ring fit together . C . NC . / /2016
set by matching the LUGS

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 Procedure Result to be observed State* Date** Operator Check
24. Place the loading ring on the locating table of closing unit N/A . C . NC . / /2016
25. Check the counter weight Proper adjustment of counter weight of closing unit
A micro switch gets actuated and the vertical pneumatic
. C . NC . / /2016
cylinder starts operating: it pushes the pin plate up
26. Push the table with the loading rings inside the machine The pneumatic cylinder remains ON for the time set in the . C . NC .
control unit / /2016
Write the time set in the control unit: ..
27. Pull out manually the closing unit with the handle, lift the
stopper up and place it on the lugs of the loading ring.
The pin plate enters the loading ring smoothly . C . NC . / /2016
Turn the whole unit through 120 approximately in
anticlockwise direction
28. Turn back the unit clockwise to its original position.
N/A . C . NC . / /2016
Remove the loading rings for the next loading cycle
* Circle the appropriate answer and cross out the other one. If any problem please comment below. C = Compliant, NC = Non-Compliant.
** Only write the date once when it is a new day. Cross out the other squares.
Comments: _____________________________________________________________________________________________________________________________
_______________________________________________________________________________________________________________________________________
_______________________________________________________________________________________________________________________________________
_______________________________________________________________________________________________________________________________________
_______________________________________________________________________________________________________________________________________
_______________________________________________________________________________________________________________________________________

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 7.7 Emergency stops
Procedure Result to be observed State* Date** Operator Check
1. Switch on the machine in automatic mode N/A . C . NC . / /2016
2. Unfit the safety guard of the loading station, press the Start (green) button The machine do not start . C . NC . / /2016
3. Fit the safety guard of the loading station, press the start button, after a few
The machine stops . C . NC . / /2016
seconds and before the end of the revolution, open the safety guard
4. Fit the safety guard of the loading station, press the start button The machine finishes its revolution . C . NC . / /2016
5. Press the start button, after a few seconds and before the end of the
The machine stops . C . NC . / /2016
revolution, press the emergency switch
6. Press again the start button The machine does not turn on . C . NC . / /2016
7. Release the emergency switch and press the start button The machine turns on . C . NC . / /2016
8. . C . NC . / /2016
* Circle the appropriate answer and cross out the other one. If any problem please comment below. C = Compliant, NC = Non-Compliant.
** Only write the date once when it is a new day. Cross out the other squares.

Comments: _____________________________________________________________________________________________________________________________
_______________________________________________________________________________________________________________________________________
_______________________________________________________________________________________________________________________________________
_______________________________________________________________________________________________________________________________________
_______________________________________________________________________________________________________________________________________
_______________________________________________________________________________________________________________________________________

7.8 Qualification of speeds

Procedure Result to be observed Speed* Date** Operator Check

1. There are 2 speeds for the auger with the 13 teeth pulley. Set the 310rpm speed and check the actual speed .. / /2016
Try them and check the speed of the auger Set the 370rpm speed and check the actual speed / /2016
..

2. There are 2 speeds for the auger with the 14 teeth pulley. Set the 288rpm speed and check the actual speed .. / /2016
Try them and check the speed of the auger Set the 344rpm speed and check the actual speed / /2016
..
.. / /2016
3. There are 9 speeds for the filling table. Try them and
.. / /2016
check the speed of the filling table
.. / /2016

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Compiler QA/QC Manager Responsible Pharmacist
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 Procedure Result to be observed Speed* Date** Operator Check
.. / /2016
.. / /2016
.. / /2016
.. / /2016
.. / /2016
.. / /2016

7.9 Trial with empty capsules

Note: only add the capsules when it is required.

Procedure Result to be observed State* Date** Operator Check

LOADING STATION
1. Make the machine ready with required size change parts
N/A . C . NC . / /2016
vacuum OFF condition.
2. ICS to be cleaned of any foreign particles and dust.
Machine clean and no damage . C . NC . / /2016
Check for any damage
3. Turn ON the main supply and switch ON the machine in
. C . NC . / /2016
manual mode
4. Load capsules into the hopper and switch ON the vacuum . C . NC . / /2016
Free flow of capsules at a time from magazine . C . NC . / /2016
5. Push IN the hand wheel located on the right hand side of
the machine and turn clockwise. Bring the magazine to One capsule from each slot of magazine is released . C . NC . / /2016
the bottom most position over the rectifier raceway
Capsule do not get locked while loading . C . NC . / /2016
6. Put the machine in AUTO mode and load the loading ring
The cycle starts . C . NC . / /2016
with capsules. Start the cycle
. C . NC .
7. If necessary, push the pin in the magazine The release of the capsules from the magazine is facilitated / /2016
N/A .
The loading table indexes anticlockwise . C . NC .
/ /2016
The loading table stops before the capsules are loaded . C . NC .

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 Procedure Result to be observed State* Date** Operator Check
8. Ensure that the required vacuum is available at the
One raw of holes on loading ring is totally aligned with vacuum
vacuum slot and place the loading ring on the loading . C . NC .
slot
table. Rotate the hand wheel
The slide starts moving back . C . NC .
The vertical blades start moving down . C . NC .
The tips of the blades will touch the capsules at its cap edge . C . NC .
9. Continue the hand wheel rotation The capsules start tilting (orientating) in the cap up and body / /2016
. C . NC .
down position (= rectification step)
If improper rectification, adjust the centering gauge as . C . NC .
described in Annex X. Check again if the rectification is correct N/A .
10. Check for pinch/marks on cap/body due to improper
No pinch/mark on capsules . C . NC . / /2016
setting of capsule release finger while loading
Rotates freely without any obstruction . C . NC . / /2016
All capsules are separated . C . NC . / /2016
11. Rotate the loading ring manually for 2 turns, then lift it
All the body ring holes are filled with bodies and their top
. C . NC . / /2016
edges are below the top surface of the body ring
FILLING STATION
12. Ensure the filling table area is cleaned properly and place
Filling table area clean . C . NC . / /2016
the body ring on the filling table
13. . C . NC . / /2016
14.
15.
The auger starts rotating in clockwise direction
16. Select the medium speed 7.3 rpm and start the filling . C . NC . / /2016

17.
18.

Procedure Result to be observed State* Date** Operator Check

POWDER FILLING
The gap between the proximity switch and body ring must be
1. Place the body ring of the loading ring on the filling table. . C . NC . / /2016
around 1 to 2mm

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 Procedure Result to be observed State* Date** Operator Check
The LED of Proximity switch starts glowing . C . NC .
The hopper swings over the body ring place on the filling table . C . NC .
The auger starts rotating in clockwise direction . C . NC .
The auger actuates the proximity switch on the housing of the
. C . NC .
2. Press the powder table Start button (green) hopper, which makes the auger start rotating / /2016
The swivel hopper comes to extreme position of swivel (i.e.
. C . NC .
auger comes over the ring) and the filling table starts
As soon as one revolution is completed, the filling table and
. C . NC .
auger stops and the hopper swings back to its initial position.
The auger starts earlier when the proximity switch is closer to
3. If necessary, the starting of auger can be adjusted based . C . NC . / /2016
the powder hopper housing
on the position of proximity switch on the powder hopper
housing The auger starts later when the proximity switch is closer to
. C . NC . / /2016
the powder hopper housing
CLOSING STATION
4. Assemble the body ring and cap ring of the loading ring
The body ring and cap ring fit together . C . NC . / /2016
set by matching the LUGS
5. Place the loading ring on the locating table of closing unit N/A . C . NC . / /2016
A micro switch gets actuated and the vertical pneumatic
cylinder starts operating: it pushes the pin plate up to join the . C . NC . / /2016
filled body and cap until capsule joining is complete
6. Push the table with the loading rings inside the machine
The pneumatic cylinder remains ON for the time set in the . C . NC .
control unit / /2016
Write the time set in the control unit: ..
7. Pull out manually the closing unit with the handle, lift the
stopper up and place it on the lugs of the loading ring. The pin plate enters the loading ring smoothly to eject out all
. C . NC . / /2016
Turn the whole unit through 120 approximately in the filled capsules
anticlockwise direction
8. Turn back the unit clockwise to its original position.
N/A . C . NC . / /2016
Remove the loading rings for the next loading cycle
9. Compare the number of filled capsules and the number The 2 numbers must Manual count: ...
. C . NC . / /2016
counted by the mechanical counter be the same Mechanical count: ...

* Circle the appropriate answer and cross out the other one. If any problem please comment below. C = Compliant, NC = Non-Compliant.
** Only write the date once when it is a new day. Cross out the other squares.

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Compiler QA/QC Manager Responsible Pharmacist
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Comments: _____________________________________________________________________________________________________________________________
_______________________________________________________________________________________________________________________________________
_______________________________________________________________________________________________________________________________________
_______________________________________________________________________________________________________________________________________
_______________________________________________________________________________________________________________________________________
_______________________________________________________________________________________________________________________________________

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Compiler QA/QC Manager Responsible Pharmacist
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 APPROVAL BY:

Date / / Date / / Date / /

Compiler Production Manager QA/QC Manager
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