PQ Coater

USV PRIVATE LIMITED
Reference SOP No: GQA-SOP-0001

PERFORMANCE QUALIFICATION DOCUMENT FOR AUTO COATING Page No.: 1 of 22
SYSTEM
Document No.: V/PQ/PRD/ACS001-00
Effective Date:
Performance Qualification
Document for
Auto coating system
(V/PRD/ACS001)
USV Private Limited, Plot No 538 to 540, 597 to 625, GIDC Industrial Area - Savli, Taluka - Savli, Manjusar, Vadodara, Gujarat - Pincode - 391775.
Form No: VEG-SOP-0001/10.6-01
CONFIDENTIAL-USV
USV PRIVATE LIMITED

SYSTEM
Sr. No. Description Page No.
1. PQ Document Pre- Approval 3
Validation/ Qualification Team.
2. 4-5
2.1 Training
3. Objective 6
4. Scope 6
5. Responsibilities 6
6. Equipment Description 7
Procedure
7. 7.1 Product Name 7-17
7.2 Operation Carried out
Verification of Standard Equipment/ Master Instrument used for
8. 18
qualification
9. Final Conclusion 19
10. PQ Document Post Approval 20
11. Qualification Certification 21
12. Document revision history 22
1. PQ Document Pre-Approval
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SYSTEM
Responsibility Name Designation Signature & Date
Prepared By
(Production Dept.)
Checked By
(Engineering Dept.)
Checked By
(Production Dept.)
Review By
(Quality Assurance)
Review By
(Plant Head)
Approved By
(QA Head)
2. Validation/ Qualification Team
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SYSTEM
Validation/ Qualification Team
2.1
Train-
ing:
Production Dept. Training
to be
imparted
to all the
involved
person
Engineering Dept.
(Qualifi-
cation/
Valida-
tion
Quality Assurance team) in
Dept. the exe-
cution of
Perfor-
mance
qualifi-
cation document for Auto coating system.
Training Time: From ………… to ………….
Sr. No. Trainee Name Designation/ De- Employee code Sign / Date
partment
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SYSTEM
Remarks:
Trainer Name:
Sign/ Date:
3. Objective:
3.1. To verify the Auto coating system performance with dummy /Trial/validation product as
intended and as per process parameters mentioned in Batch Manufacturing Record.
3.2. To record all relevant information and data observed during performance qualification.
3.3. To demonstrate that the results of the performance trials of the Auto Coating system
consistently meets the predetermine specifications under normal operating condition.
4. Scope:
The protocol describes the performance qualification parameters along with the procedure
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SYSTEM
and acceptance criteria for Auto coating system (V/PRD/ACS001) installed in Coating-1
area (Room ID. No. F87) of Production department in Formulation Facility at USV private
limited, Vadodara.
5. Responsibilities:
Sr.
Department Responsibility
No.
 To prepare and check the Performance Qualification Protocol.
 To ensure operation, recording & check of performance data as
Production per the procedure outlined in this protocol.
1
Department
 To compile the documents required during Performance Qualifi-
cation.
 To check the Performance Qualification Protocol.
 To assist in ensuring the Performance activity during Perfor-
mance qualification.
2 Engineering  To check the data generated during Performance Qualifica-
tion.
 To assist in ensuring the Performance activity as per safety re-
quirement.
Quality  To perform the quality test as mention in this Protocol.
3
Control
Quality  To withdraw sample and to review the Performance Qualification

4 results and its compliance with respect to acceptance criteria.
Assurance
6. Equipment Description
Equipment Name : AUTO COATING SYSTEM
Equipment Code : V/PRD/ACS001
Location : Coating-1 (F87)
Capacity : 1850 Liter
Effectiveness for implementation of below listed SOP’s/documents shall be ensured
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USV PRIVATE LIMITED

SYSTEM
before
start of the performance qualification activities.
Sr. Document No./ Verified By
Document Name Effective Date
No. SOP No. Sign/date
SOP for operation and cleaning of

1. VMF-SOP-0027
Autocoating system.
7. Procedure:
7.1. Product Name:
Product Name and Batch No.
1st Batch:
Product Name: ______________________________________________________________
Batch No.: ______________________
2nd Batch:
Product Name: ______________________________________________________________
Batch No.: ______________________
3rd Batch:
Product Name: ______________________________________________________________
Batch No.: ______________________
7.2. Operation Carried Out:

7.2.1. Performance Qualification Procedure:
Procedure for Film Coating:
1. Start the Auto coating system as per starting procedure (as par reference SOP).
2. Measure the Pan RPM of Automatic coating system with respect to set RPM using
calibrated tachometer.
3. Perform Gun validation and spray rate determination of peristaltic pump.
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4. Check inlet air temperature of Auto coating system with respect to set value.
5. Check exhaust air temperature of Auto coating system with respect to set value.
6. Measure the Peristaltic Pump RPM of Auto coating system with respect to set RPM
using calibrated tachometer.
7. Visually check the 100% discharging of coated tablet.
8. Record the observation of weight of tablets and calculate the weight gain.
9. Repeat the same process for the three consecutive dummy /Trial/validation batches.
10. Record the observation in respective table.
7.2.2. Sampling Plan: In process checks for tablet weight gain and appearance as per
respective BMR.
7.2.3. Acceptance Criteria and Target Value:
Acceptance Criteria and Target

Test Name Frequency
Value
Verification of Pan RPM It should be ± 1 RPM of set RPM Before start of the batch
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SYSTEM
Verification of Appearance at As per specification in BMR and free

the end of Charging of tablets in from defects.
Three Batches/Lots
coating pan After Charging of tablets no any
physical damage observed.
Verification of coating parameter

Inlet Air Temperature It should be ± 5°C of set value
Exhaust Air Temperature Should not exceed its high set value
Peristaltic Pump RPM It should be ± 1 RPM of set RPM
Atomization Pressure It should be ± 0.6 bar of set value

As per specification in BMR and as
Weight Gain (% w/w) per requirement in case of dummy
batch
As per specification in BMR and free Three Batches/Lots

Verification of appearance and from defects in case of dummy tablets
Discharging at the end of
coating After discharging not a single tablet
should remain in coating pan
Direction of coating pan should be
clockwise in coating process
Verification of Direction of
coating pan Direction of coating pan should be
anti-clockwise in discharging process.
Before loading of core tablets in auto coating system perform Pan RPM and Gun validation
test as mention below.
7.2.4. Verification of Pan RPM:
Observation table for verification of Pan RPM
Tachometer ID No:_____________________
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Acceptance criteria: It should be ±1 RPM of set RPM.
Checked By
Sr. Batch/Lot Set Pan Observed Target Done
Date
No. No. RPM RPM value By
Prod. QA
7.2.5. Gun validation and spray rate determination of peristaltic pump.

Spray gun diameter: ____________________ No. of Spray Gun: _____________________
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SYSTEM
Measuring cylinder ID: ___________________
Weighing balance ID: ____________________
Stop watch ID: _________________________
Spray Done Checked

Batch/ Spray Rate (g/min/gun) Total
Date pump By By
Lot No.
RPM 1 2 3 4 5 6 7 8 9 10 Prod QA
7.2.6. Verification of Appearance at the end of Charging of tablets in coating pan:

After Loading of Tablets in coating pan, visually check the tablet appearance
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SYSTEM
Acceptance Criteria:
Appearance: As per specification in BMR and free from defects.
Charging: After Charging of tablets no any physical damage observed.
Appearance at the Checked By

end of Charging
Sr. No. Batch/ Lot No. Date Done By
of tablets (Ok/
Not Ok) Prod. QA
7.2.7. Observation table for verification of coating parameter:

Tachometer ID No:_____________________
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SYSTEM
Inlet Air Temp : ± 5 °C of set value.
Exhaust Air Temp : Should not be exceed its high set value.
Pump RPM : ± 1 RPM of set RPM.
Atomization Pressure : ±0.6 bar of set value.
Sr. Batch/ Target Done Checked By
Parameter Date Set Actual
No. Lot No. Value By Prod QA
Inlet Air
1
Temp. (°C)
Exhaust Air
2
Temp. (°C)
3 Pump RPM
Atomization
4
Pressure (bar)
7.2.8. Verification of Appearance and Discharging at the end of coating:
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SYSTEM
Appearance: As per specification in BMR and free from defects.
Discharging: After discharging not a single tablet should remain in coating pan.
Appearance
Discharging Checked By
Sr. Batch/ Lot at the end of Done
Date (Satisfactory/ Not
No. No. coating (Ok/ By
Satisfactory) Prod. QA
Not Ok)
7.2.9. Verification of Direction of Coating pan:
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USV PRIVATE LIMITED

SYSTEM
During Coating process: Direction of coating pan during Coating should be clockwise.
Direction of Checked By
Batch/ Lot
Date coating pan during Done By
No.
Coating
Prod. QA
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USV PRIVATE LIMITED

SYSTEM
During Discharging process: Direction of coating pan during Discharging should be anticlockwise.
Direction of Checked By
Batch/ Lot
Date coating pan during Done By
No.
Discharging
Prod. QA
7.2.10. Acceptance Criteria:
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USV PRIVATE LIMITED

SYSTEM
Test Batch No. Batch No. Batch No.
Specifications
Parameter
Description
Average
Weight (mg) As per BMR

Thickness
(mm)
Length (mm)
Width (mm)
Weight Gain
(% w/w)
Checked by
Production Dept. Quality Assurance Dept.

8. Verification of Standard Equipment/ Master Instrument used for qualification:
1.1. The description, identification and validity of calibration (as applicable) of the test equip-
ments/ master instruments shall be listed in this section.
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USV PRIVATE LIMITED

SYSTEM
1.2. Attach the copy of calibration certificates of these equipments (as applicable) with the
qualification report.
List of Standard Equipment/ Master Instrument used for qualification

Calibration
Instrument/ Recorded
Sr. Instrument Next
Equipment Calibration By
No. ID No. Traceability Due
Name Done Date (Sign/Date)
Date
Remarks:
Checked by

9. Final Conclusion:
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USV PRIVATE LIMITED

SYSTEM
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Checked by

10. PQ Document Post Approval:
CONFIDENTIAL-USV
USV PRIVATE LIMITED

SYSTEM
Compiled By
(Production Dept.)
Checked By
(Engineering Dept.)
Checked By
(Production Dept.)
Review By
(Quality Assurance)
Review By
(Plant Head)
Approved By
(QA Head)
11. Qualification Certification:
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USV PRIVATE LIMITED

SYSTEM
QUALIFICATION CERTIFICATE
Performance Qualification of_______________________________
Equipment No.___________________________________________
Was conducted according to PQ Document No._________________
Performance Qualification Completed on______________________
And the Equipment is released for____________________________
_____________ _____________
HOD Production Dept. QA Head

Sign/Date Sign/Date
12. Document Revision History
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SYSTEM
Document revision History
Sr. No. Date of Revision Revision No. Reason for Revision
(Effective date)
1 NA 00 New Protocol
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USV PRIVATE LIMITED

Reference SOP No: GQA-SOP-0001

Reference SOP No: GQA-SOP-0001

10. PQ Document Post Approval 20

11. Qualification Certification 21

12. Document revision history 22

Reference SOP No: GQA-SOP-0001

Responsibility Name Designation Signature & Date

2. Validation/ Qualification Team

Reference SOP No: GQA-SOP-0001

Validation/ Qualification Team

Responsibility Name Designation Signature & Date

Reference SOP No: GQA-SOP-0001

Reference SOP No: GQA-SOP-0001

Quality  To withdraw sample and to review the Performance Qualification

Effectiveness for implementation of below listed SOP’s/documents shall be ensured

Reference SOP No: GQA-SOP-0001

SOP for operation and cleaning of

Batch No.: ______________________

Batch No.: ______________________

Batch No.: ______________________

7.2. Operation Carried Out:

Reference SOP No: GQA-SOP-0001

7.2.3. Acceptance Criteria and Target Value:

Acceptance Criteria and Target

Reference SOP No: GQA-SOP-0001

Verification of Appearance at As per specification in BMR and free

Verification of coating parameter

Peristaltic Pump RPM It should be ± 1 RPM of set RPM

Atomization Pressure It should be ± 0.6 bar of set value

As per specification in BMR and free Three Batches/Lots

Reference SOP No: GQA-SOP-0001

7.2.5. Gun validation and spray rate determination of peristaltic pump.

Reference SOP No: GQA-SOP-0001

Spray Done Checked

7.2.6. Verification of Appearance at the end of Charging of tablets in coating pan:

Reference SOP No: GQA-SOP-0001

Appearance at the Checked By

7.2.7. Observation table for verification of coating parameter:

Reference SOP No: GQA-SOP-0001

7.2.8. Verification of Appearance and Discharging at the end of coating:

Reference SOP No: GQA-SOP-0001

7.2.9. Verification of Direction of Coating pan:

Reference SOP No: GQA-SOP-0001

Reference SOP No: GQA-SOP-0001

7.2.10. Acceptance Criteria:

Reference SOP No: GQA-SOP-0001

Weight (mg) As per BMR

Production Dept. Quality Assurance Dept.

Reference SOP No: GQA-SOP-0001

List of Standard Equipment/ Master Instrument used for qualification

Production Dept. Quality Assurance Dept.

Reference SOP No: GQA-SOP-0001

Production Dept. Quality Assurance Dept.

Reference SOP No: GQA-SOP-0001

11. Qualification Certification:

Reference SOP No: GQA-SOP-0001

Was conducted according to PQ Document No._________________

Performance Qualification Completed on______________________

And the Equipment is released for____________________________

HOD Production Dept. QA Head

12. Document Revision History

Reference SOP No: GQA-SOP-0001