PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.

:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

Sr. No. ITEM DESCRIPTION Page No.

1.0 PROTOCOLAPPROVAL 3
2.0 OVERVIEW: 4
2.1 Objective 4
2.2 Purpose 4
2.3 Scope 4
2.4 Responsibility 5
2.5 Execution Team 6
3.0 PREREQUISITE 7
4.0 REVALIDATION CRITERIA 7
5.0 PERFORMANCE QUALIFICATION PROCEDURE 8-10
5.1 Methodology 8 -10
6.0 ACCEPTANCE CRITERIA 10
7.0 MATERIAL REQUIRED FOR COATING 11
8.0 VALIDATION MATRIX 11
9.0 INPROCESS SPECIFICATION OF ROUND, OVAL AND 12
CAPSULE SHAPE
10.0 VERIFICATION OF COATING PARAMETER 13-49
10.1 Coating parameter for round shape for maximum batch size 13-18
10.2 Coating parameter for round shape for minimum batch size 19-24
10.3 Coating parameter for oval shape for maximum batch size 25-30
10.4 Coating parameter for oval shape for minimum batch size 31-36
10.5 Coating parameter for capsule shape for maximum batch size 37-42
10.6 Coating parameter for capsule shape for minimum batch size 43-48
10.7 Composite assay result of coated tablets 49
11.0 DEFICIENCY AND CORRECTIVE ACTIONS 50
12.0 ANNEXURE (S) 51
13.0 PERFORMANCE QUALIFICATION FINAL REPORT 52-53
13.1 Summary 52
13.2 Conclusion 52
13.3 Final report approval 53
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

1.0 PROTOCOL APPROVAL:

Signing of this approval page of Protocol indicates agreement with the qualification approach
described in this document. If modification to the qualification approach becomes necessary, an
addendum shall be prepared and approved .The protocol cannot be used for execution unless
approved by the following authorities.
This performance qualification protocol of Autocoater has been reviewed and approved by the
following persons:

FUNCTION NAME DESIGNATION DEPARTMENT SIGNATURE DATE

PREPARED QUALITY
BY ASSURANCE

QUALITY
ASSURANCE
REVIEWED
ENGINEERING
BY
QUALITY
CONTROL

HEAD
OPERATION
APPROVED
BY
QUALITY
ASSURANCE
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

2.0 OVERVIEW:

2.1 OBJECTIVE:

The objective of developing and executing this protocol is to

 Document the verification of all aspects of the equipment that can affect
product quality.

 To establish, check and document the performance of equipment in the

established/predetermined operating ranges.

2.2 PURPOSE:

The purpose of this protocol is to verify that the equipment produces the desired
output. Performance qualification of the equipment is planned after the successful
completion of the installation and operational qualification.

The equipment working capacity is recommended by manufacturer challenged by

charging the tablets with the maximum and minimum capacity of the pan.

2.3 SCOPE:

The protocol shall define the test procedures, documentation, references and
acceptance criteria to establish that the performance of the equipment shall meet the
predetermined acceptance criteria.

The Scope of this protocol is limited to the performance qualification of Autocoater

installed in coating area.

Once the performance qualification of Autocoater has been completed successfully,

the equipment shall be released for the production purposes.
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

2.4 RESPONSIBILITY:

In accordance with protocol, following functions shall be responsible for the

qualification of system.

Execution Team (Comprising members from Production, Quality control ,

Engineering and Quality Assurance) and their responsibilities are following:
 Prepares the performance qualification protocol.
 Ensures that the protocol is in compliance with current policies and procedures
on system Qualification.
 Distributes the finalized protocol for review and approval signatures.
 Execution of Qualification protocol.
 Review of protocol, the completed qualification data package, and the final
report.
 The analysis of sample shall be carried out by quality control department.
 Engineering department shall support for execution.
 The production operator / supervisor shall carry out the cleaning and operation
of machine.

Head – Quality control / Production / Engineering:

 Review of protocol, the completed qualification data package, and the final
report.
 Assist in the resolution of validation deficiencies.

Head – Operation and Quality Assurance:

 Review and approval of protocol, the completed qualification data package,
and the final report.
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

2.5 EXECUTION TEAM:

The satisfactory operation of the Autocoater shall be verified by executing the performance
qualification studies described in this protocol. The successfully executed protocol
documents that the Autocoater is operational and is satisfactorily working.
Execution team is responsible for the execution of performance qualification of the
Autocoater. Execution team comprises of:

NAME DESIGNATION DEPARTMENT SIGNATURE DATE

 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

3.0 PREREQUISITE

3.1 Approved Standard operating procedure of the equipment shall be available.

3.2 The maximum and minimum capacity of the equipment shall be verified by taking the
batch/lot to suit the requirement.

3.3 The installation and operational qualification of the equipment shall be successfully
completed before the execution of the performance qualification.

3.4 All the deficiencies and discrepancies related to the equipment which affect the product
quality and corrective action taken shall be recorded in the appropriate section of the
protocol.

3.5 After completion of PQ activities, equipment shall be cleaned as per respective cleaning
SOP’s and released for manufacturing.

4.0 REVALIDATION CRITERIA:

The machine shall be revalidated if

 There are any major changes, which affect the performance of the equipment.

 Batch/lot size taken out of the range on which performance is done

 As per revalidation date and schedule

 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

5.0 PERFORMANCE QUALIFICATION PROCEDURE

5.1 METHODOLOGY:
 Pan Capacity Determination
Compressed tablets should be charged into the coating pan, start rotating the coating
pan. None of the tablet should be coming out from the coating pan for maximum
capacity.
 Verification of Coating Process
Visual Inspection, Verify weight gain of Tablet after coating process.
Establish coater capacity with Hardware and software to perform without any
interruptions and trouble.
 Purpose
The purpose of the coating system is to uniformly coat tablets with coating solution for
minimum capacity and for maximum capacity (as per BMR Batch No. ---------------------
--) Critical process characteristics are monitored throughout the trials to ensure that
coated product produced should have uniform coating & appearance. Tablets should not
lose their characteristics during coating process.
 Processing Steps: The coating process is divided in the following process steps:
Preparation of the coating solution.
The coating solution sufficient for one batch of coating is prepared in a Solution
Preparation vessel. The Solution shall be transferred into SS tank manually and
connected to the Coating System
 Coating Process
 The uncoated Tablets are charged in the Coater. Coating solution is sprayed to coat the
Tablets. Inlet air and exhaust system is provided to supply conditioned air and exhaust
the solvent rich air.
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

 Test Method:
Set process parameters for Coating System as determined in PQ BMR Parameters
defined shall be appropriate to have airflow for uniform atomization.
Coating shall be done on caplet, oval and round shape tablets for minimum and
maximum capacity verification for each shape.
Charge uncoated Tablets & prepare coating solution as per PQ BMR recipe and set
process parameters, which includes a heating, a spraying and a cooling phase sequence.
Start the Coating System with the specified recipe.
Check the coating of the product bed visually every 15 minutes through sight glass.
On completion of the coating process discharge the coated tablets.
Record the test data and any observations throughout the process in the PQ BMR as well
as PQ report
Samples of tablets are taken and tested as follows:
20 tablet composite from ten sampling locations to be collect and individually
uniformity of weight to be performed to identify potential areas of poor coating.
Samples are analyzed, according to applicable testing procedure for appearance and
weight gain.
Test for Appearance, Weight Variation, Disintegration time & Thickness to be
performed and note down in column provided.
One PQ batch must be tested as described before, in order to demonstrate consistent
performance.
The different shaped tablet (Such as round shape, capsule, oval shape) used for
coating pan verification and also minimum and maximum capacity to be verify
taking the compressed tablet and process follows as per mentioned in PQ BMR.
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

Sampling Location Diagram of Auto Coater:

1 3

5 10
6
4 7

8 9

6.0 ACCEPTANCE CRITERIA:

6.1 Tablets should have uniform appearance as seen visibly.

6.2 Weight Gain

20 tablets shall be weighed from 10 different locations. The weight gain should not be
less than 1.5 %. Results of weight of 20 tablets, disintegration time and thickness should
be within the limit.

6.3 All hardware and software components shall perform without problems and
interruptions while processing the complete batch for capacities as agreed with the
equipment supplier

6.4 Appearance, Weight Variation, Thickness, should be with in limit as specified in PQ

BMR.
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

7.0 MATERIAL REQUIRED FOR COATING:

 Raw Materials (Tablets) in sufficient quantity as per BMR Batch No. ------------
 Coating liquid in sufficient quantity
 Sample containers or sample bags.
 IPC

8.0 VALIDATION MATRIX:

Pan size: Pan working capacity:
36” Min. – 14 kg & Max. – 59 kg

Wt. of core Observed

Shape of core tablets Batch no to be Checked by
[Link]. tablet taken Avg. wt. Of
used for coating taken Sign& Date
for coating core tablets
Round shape tablet
1.
for minimum capacity
Round shape tablet
2. for maximum
capacity
Capsule shape tablet
3.
for minimum capacity
Capsule shape tablet
4. for maximum
capacity

5. Oval shape tablet for

minimum capacity

6. Oval shape tablet for

maximum capacity
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

9.0 In process specification for round oval and capsule shape tablet:

INPROCESS SPECIFICATION

Specification for Specification for Specification for

[Link]. Parameter
Round shape Capsule shape Oval shape
Circular biconvex film Capsule shaped Oval, biconvex film
coated tablets having biconvex film coated coated tablets
1 Appearance
plain surface on both tablets having plain having plain on both
sides. surface on both sides. sides.
Weight of 20 7.18 g ± 2.5% 13.872 g ± 2.5% 5.42 g ± 2.5%
2
tablets (7.001 g – 7.360 g) (13.526 – 14.219 g) (5.285 g – 5.556 g)
4.20  0.20 mm
4.20  0.30 mm 4.70  0.20 mm
3 Thickness (4.00 mm – 4.40
(3.90 mm – 4.50 mm) (4.50 mm – 4.90 mm)
mm)
Disintegration
4 NMT 30 Minutes NMT 30 Minutes NMT 30 Minutes
time
359.0 mg ± 5% 693.6 mg ± 5% 271.0 mg ± 5%
Uniformity of
5
Weight (341.05 mg – 376.95 ( 658.92 mg – 728.28 (257.45 mg – 284.55
mg) mg) mg)
359.0 mg ± 2.5% 693.6 mg ± 2.5% 264.23 mg ± 2.5%
Average
6
Weight (350.03 mg – 367.98 ( 676.26 mg – 710.94 (257.45 mg – 277.78
mg) mg) mg)
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

10.0 VERIFICATION OF COATING INPROCESS PARAMETERS:

10.1 Coating parameter for round shape for maximum batch size.
Checked
[Link] Parameter Specification Actual Observation
By Sign
1. Pan load (36”) Approx. 59 kg
2. Inlet Temperature 55 ± 5 OC

3. Exhaust Temperature 40 ± 5 OC

4. Pan RPM ____± ____

____ ± ____ g /
5. Spray rate
minute / gun
6. Bed temperature 40 ± 4OC
7. No of spray guns 04
Diameter of the nozzle
8. 1.2 mm
of spray gun
Distance between
9. –––
tablet bed & nozzle

Remark:
----------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------

Reviewed by (Sign/Date)
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

INPROCESS CHECKS (Production)

Weight of 20 Disintegration Thickness
Tablets Time Checked
Date Appearance 4.20  0.30 mm
7.18 g ± 2.5% Limit: NMT by
(3.90 mm – 4.50 mm)
(7.001 g – 7.359 g) 30 minutes

Uniformity of weight coated tablets 359.0 mg ± 5% (341.05 mg – 376.95 mg) – By production

Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg:
Checked by:

Remark:
----------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------

Reviewed by (Sign/Date)
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

INPROCESS CHECKS (QA)

Weight of 20
Disintegration Thickness
Tablets
Time 4.20  0.30 mm Checked
Date Appearance 7.18 g ± 2.5%
Limit: NMT 30 (3.90 mm – 4.50 by
(7.001 g – 7.359 minutes mm)
g)

Uniformity of weight for coated tablets to be performed from different locations

Location - I
Uniformity of weight coated tablets 359.0 mg ± 5%(341.05 mg – 376.95 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - II
Uniformity of weight coated tablets 359.0 mg ± 5%(341.05 mg – 376.95 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - III
Uniformity of weight coated tablets 359.0 mg ± 5%(341.05 mg – 376.95 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

Location - IV
Uniformity of weight coated tablets 359.0 mg ± 5%(341.05 mg – 376.95 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - V
Uniformity of weight coated tablets 359.0 mg ± 5%(341.05 mg – 376.95 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

Location - VI
Uniformity of weight coated tablets 359.0 mg ± 5%(341.05 mg – 376.95 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - VII
Uniformity of weight coated tablets 359.0 mg ± 5%(341.05 mg – 376.95 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - VIII
Uniformity of weight coated tablets 359.0 mg ± 5%(341.05 mg – 376.95 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

Location - IX
Uniformity of weight coated tablets 359.0 mg ± 5%(341.05 mg – 376.95 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - X
Uniformity of weight coated tablets 359.0 mg ± 5%(341.05 mg – 376.95 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

RESULTS OF MAXIMUM ROUND SHAPE:

Checked
Tests Acceptance Criteria Observation By
Sign/Date
Pan capacity Determination According to the capacity as
specified by supplier
Visual Inspection Sample Uniform in appearance
20 tablets at each sampling
location.
Verify weight gain of The average wt. gain should
Tablet after coating. not be less than 1.5%.
Composite 20 tab let
Sample 10 location
Establish coater capacity Hardware and software to
with Hardware and perform without any
software to perform interruptions and trouble.
without any interruptions
and trouble.
Physical & chemical Weight Variation, Thickness,
characteristics Friability, Hardness, and
disintegration should be
within limits specified in PQ
BMR.

Remark :
----------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------

Checked By (Sign/Date)
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

10.2 Coating parameter for round shape for minimum batch size.
Checked
[Link] Parameter Specification Actual Observation
By Sign
1. Pan load (36”) Approx. 14 kg
2. Inlet Temperature 55 ± 5 OC

3. Exhaust Temperature 40 ± 5 OC

4. Pan RPM ____± ____

____ ± ____ g /
5. Spray rate
minute / gun
6. Bed temperature 40 ± 4OC
7. No of spray guns 04
Diameter of the nozzle
8. 1.2 mm
of spray gun
Distance between
9. –––
tablet bed & nozzle

Remark:
----------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------

Reviewed by (Sign/Date)
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

INPROCESS CHECKS (Production)

Weight of 20 Disintegration Thickness
Tablets Time Checked
Date Appearance 4.20  0.30 mm
7.18 g ± 2.5% Limit: NMT by
(3.90 mm – 4.50 mm)
(7.001 g – 7.359 g) 30 minutes

Uniformity of weight coated tablets 359.0 mg ± 5% (341.05 mg – 376.95 mg) – By production

Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg:
Checked by:

Remark:
----------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------

Reviewed by (Sign/Date)
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

INPROCESS CHECKS (QA)

Weight of 20
Disintegration Thickness
Tablets
Time 4.20  0.30 mm Checked
Date Appearance 7.18 g ± 2.5%
Limit: NMT 30 (3.90 mm – 4.50 by
(7.001 g – 7.359 minutes mm)
g)

Uniformity of weight for coated tablets to be performed from different locations

Location - I
Uniformity of weight coated tablets 359.0 mg ± 5%(341.05 mg – 376.95 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - II
Uniformity of weight coated tablets 359.0 mg ± 5%(341.05 mg – 376.95 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - III
Uniformity of weight coated tablets 359.0 mg ± 5%(341.05 mg – 376.95 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

Location - IV
Uniformity of weight coated tablets 359.0 mg ± 5%(341.05 mg – 376.95 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - V
Uniformity of weight coated tablets 359.0 mg ± 5%(341.05 mg – 376.95 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

Location - VI
Uniformity of weight coated tablets 359.0 mg ± 5%(341.05 mg – 376.95 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - VII
Uniformity of weight coated tablets 359.0 mg ± 5%(341.05 mg – 376.95 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - VIII
Uniformity of weight coated tablets 359.0 mg ± 5%(341.05 mg – 376.95 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

Location - IX
Uniformity of weight coated tablets 359.0 mg ± 5%(341.05 mg – 376.95 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - X
Uniformity of weight coated tablets 359.0 mg ± 5%(341.05 mg – 376.95 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

RESULTS OF MINIMUM ROUND SHAPE:

Tests Checked By
Acceptance Criteria Observation
Sign/Date
Pan capacity Determination According to the capacity as
specified by supplier
Visual Inspection Sample Uniform in appearance
20 tablets at each sampling
location.
Verify weight gain of The average wt. gain should
Tablet after coating. not be less than 1.5%.
Composite 20 tab let
Sample 10 location
Establish coater capacity Hardware and software to
with Hardware and perform without any
software to perform interruptions and trouble.
without any interruptions
and trouble.
Physical & chemical Weight Variation, Thickness,
characteristics Friability, Hardness, and
disintegration should be
within limits specified in PQ
BMR.

Remark:
----------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------

Checked By (Sign/Date)
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

10.3 Coating parameter for oval shape for Maximum batch size.
Checked
[Link]. Parameter Specification Actual Observation
By Sign
1. Pan load (36”) Approx. 59 kg
2. Inlet Temperature 55 ± 5 OC

3. Exhaust Temperature 40 ± 5 OC

4. Pan RPM ____± ____

____ ± ____ g /
5. Spray rate
minute / gun
6. Bed temperature 40 ± 4OC
7. No of spray guns 04
Diameter of the nozzle
8. 1.2 mm
of spray gun
Distance between
9. –––
tablet bed & nozzle

Remark:
----------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------

Reviewed by (Sign/Date)
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

INPROCESS CHECKS (Production)

Weight of 20 Disintegration Thickness
Tablets Time Checked
Date Appearance 4.20  0.20 mm
5.42 g ± 2.5% Limit: NMT by
(4.00 mm – 4.40 mm)
(5.285 g – 5.555 g) 30 minutes

Uniformity of weight coated tablets 271.0 mg ± 5%(257.45 mg – 284.55 mg) – By production

Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg:
Checked by:

Remark:
---------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------

Reviewed by (Sign/Date)
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

INPROCESS CHECKS (QA)

Weight of 20
Disintegration Thickness
Tablets
Time 4.20  0.20 mm Checked
Date Appearance 5.42 g ± 2.5%
Limit: NMT 30 (4.00 mm – 4.40 by
(5.285 g – 5.555 minutes mm)
g)

Uniformity of weight for coated tablets to be performed from different locations

Location - I
Uniformity of weight coated tablets 271.0 mg ± 5%(257.45 mg – 284.55 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - II
Uniformity of weight coated tablets 271.0 mg ± 5%(257.45 mg – 284.55 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - III
Uniformity of weight coated tablets 271.0 mg ± 5%(257.45 mg – 284.55 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

Min: Max: Average Weight in mg: Checked

by:

Location - IV
Uniformity of weight coated tablets 271.0 mg ± 5%(257.45 mg – 284.55 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - V
Uniformity of weight coated tablets 271.0 mg ± 5%(257.45 mg – 284.55 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

Location - VI
Uniformity of weight coated tablets 271.0 mg ± 5%(257.45 mg – 284.55 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - VII
Uniformity of weight coated tablets 271.0 mg ± 5%(257.45 mg – 284.55 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - VIII
Uniformity of weight coated tablets 271.0 mg ± 5%(257.45 mg – 284.55 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

Location - IX
Uniformity of weight coated tablets 271.0 mg ± 5%(257.45 mg – 284.55 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - X
Uniformity of weight coated tablets 271.0 mg ± 5%(257.45 mg – 284.55 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

RESULTS OF MAXIMUM OVAL SHAPE:

Checked By
Tests Acceptance Criteria Observation
Sign/Date
Pan capacity Determination According to the capacity as
specified by supplier
Visual Inspection Sample Uniform in appearance
20 tablets at each sampling
location.
Verify weight gain of The average wt. gain should
Tablet after coating. not be less than 1.5%.
Composite 20 tab let
Sample 10 location
Establish coater capacity Hardware and software to
with Hardware and perform without any
software to perform interruptions and trouble.
without any interruptions
and trouble.
Physical & chemical Weight Variation, Thickness,
characteristics Friability, Hardness, and
disintegration should be
within limits specified in PQ
BMR.

Remark:
----------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------

Checked By (Sign/Date)
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

10.4 Coating parameter for oval shape for Minimum batch size.
Checked
[Link]. Parameter Specification Actual Observation
By Sign
1. Pan load (36”) Approx. 14 kg
2. Inlet Temperature 55 ± 5 OC

3. Exhaust Temperature 40 ± 5 OC

4. Pan RPM ____± ____

____ ± ____ g /
5. Spray rate
minute / gun
6. Bed temperature 40 ± 4OC
7. No of spray guns 04
Diameter of the nozzle
8. 1.2 mm
of spray gun
Distance between
9. –––
tablet bed & nozzle

Remark:
----------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------

Reviewed by (Sign/Date)
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

INPROCESS CHECKS (Production)

Weight of 20 Disintegration Thickness
Tablets Time Checked
Date Appearance 4.20  0.20 mm
5.42 g ± 2.5% Limit: NMT by
(4.00 mm – 4.40 mm)
(5.285 g – 5.555 g) 30 minutes

Uniformity of weight coated tablets 271.0 mg ± 5%(257.45 mg – 284.55 mg) – By production

Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg:
Checked by:

Remark:
---------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------

Reviewed by (Sign/Date)
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

INPROCESS CHECKS (QA)

Weight of 20
Disintegration Thickness
Tablets
Time 4.20  0.20 mm Checked
Date Appearance 5.42 g ± 2.5%
Limit: NMT 30 (4.00 mm – 4.40 by
(5.285 g – 5.555 minutes mm)
g)

Uniformity of weight for coated tablets to be performed from different locations

Location - I
Uniformity of weight coated tablets 271.0 mg ± 5%(257.45 mg – 284.55 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - II
Uniformity of weight coated tablets 271.0 mg ± 5%(257.45 mg – 284.55 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - III
Uniformity of weight coated tablets 271.0 mg ± 5%(257.45 mg – 284.55 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

Min: Max: Average Weight in mg: Checked

by:

Location - IV
Uniformity of weight coated tablets 271.0 mg ± 5%(257.45 mg – 284.55 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - V
Uniformity of weight coated tablets 271.0 mg ± 5%(257.45 mg – 284.55 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

Location - VI
Uniformity of weight coated tablets 271.0 mg ± 5%(257.45 mg – 284.55 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - VII
Uniformity of weight coated tablets 271.0 mg ± 5%(257.45 mg – 284.55 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - VIII
Uniformity of weight coated tablets 271.0 mg ± 5%(257.45 mg – 284.55 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

Location - IX
Uniformity of weight coated tablets 271.0 mg ± 5%(257.45 mg – 284.55 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - X
Uniformity of weight coated tablets 271.0 mg ± 5%(257.45 mg – 284.55 mg) – By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

RESULTS OF MINIMUM OVAL SHAPE:

Checked By
Tests Acceptance Criteria Observation
Sign/Date
Pan capacity Determination According to the capacity as
specified by supplier
Visual Inspection Sample Uniform in appearance
20 tablets at each sampling
location.
Verify weight gain of The average wt. gain should
Tablet after coating. not be less than 1.5%.
Composite 20 tab let
Sample 10 location
Establish coater capacity Hardware and software to
with Hardware and perform without any
software to perform interruptions and trouble.
without any interruptions
and trouble.
Physical & chemical Weight Variation, Thickness,
characteristics Friability, Hardness, and
disintegration should be
within limits specified in PQ
BMR.

Remark:
----------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------

Checked By (Sign/Date)
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

10.5 Coating parameter for capsule shape for Maximum batch size.
Checked
[Link]. Parameter Specification Actual Observation
By Sign
1. Pan load (36”) Approx. 59 kg
2. Inlet Temperature 55 ± 5 OC

3. Exhaust Temperature 40 ± 5 OC

4. Pan RPM ____± ____

____ ± ____ g /
5. Spray rate
minute / gun
6. Bed temperature 40 ± 4OC
7. No of spray guns 04
Diameter of the nozzle
8. 1.2 mm
of spray gun
Distance between
9. –––
tablet bed & nozzle

Remark:
----------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------

Reviewed by (Sign/Date)
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

INPROCESS CHECKS (Production)

Weight of 20
Tablets Disintegration Thickness
Time Checked
Date Appearance 13.872 g ± 2.5% 4.70  0.20 mm
Limit: NMT by
(13.526 – 14.218 30 minutes (4.50 mm – 4.90 mm)
g)

Uniformity of weight coated tablets 693.6 mg ± 5% ( 658.92 mg – 728.28 mg) – By

production
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg:
Checked by:

Remark:
----------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------

Reviewed by (Sign/Date)
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

INPROCESS CHECKS (QA)

Weight of 20
Disintegration Thickness
Tablets
Time 4.70  0.20 mm Checked
Date Appearance 13.872 g ± 2.5%
Limit: NMT 30 (4.50 mm – 4.90 by
(13.526 – 14.218 minutes mm)
g)

Uniformity of weight for coated tablets to be performed from different locations

Location - I
Uniformity of weight coated tablets 693.6 mg ± 5% (658.92 mg – 728.28 mg)– By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - II
Uniformity of weight coated tablets 693.6 mg ± 5% (658.92 mg – 728.28 mg)– By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - III
Uniformity of weight coated tablets 693.6 mg ± 5% (658.92 mg – 728.28 mg)– By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - IV
Uniformity of weight coated tablets 693.6 mg ± 5% (658.92 mg – 728.28 mg)– By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - V
Uniformity of weight coated tablets 693.6 mg ± 5% (658.92 mg – 728.28 mg)– By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

Location - VI
Uniformity of weight coated tablets 693.6 mg ± 5% (658.92 mg – 728.28 mg)– By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - VII
Uniformity of weight coated tablets 693.6 mg ± 5% (658.92 mg – 728.28 mg)– By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - VIII
Uniformity of weight coated tablets 693.6 mg ± 5% (658.92 mg – 728.28 mg)– By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

Location - IX
Uniformity of weight coated tablets 693.6 mg ± 5% (658.92 mg – 728.28 mg)– By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - X
Uniformity of weight coated tablets 693.6 mg ± 5% (658.92 mg – 728.28 mg)– By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

RESULTS OF MAXIMUM CAPSULE SHAPE:

Tests Checked By
Acceptance Criteria Observation
Sign/Date
Pan capacity Determination According to the capacity as
specified by supplier
Visual Inspection Sample Uniform in appearance
20 tablets at each sampling
location.
Verify weight gain of The average wt. gain should
Tablet after coating. not be less than 1.5%.
Composite 20 tab let
Sample 10 location
Establish coater capacity Hardware and software to
with Hardware and perform without any
software to perform interruptions and trouble.
without any interruptions
and trouble.
Physical & chemical Weight Variation, Thickness,
characteristics Friability, Hardness, and
disintegration should be
within limits specified in PQ
BMR.

Remark :
---------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------

Checked By (Sign/Date)
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

10.6 Coating parameter for capsule shape for minimum batch size.
Checked
[Link] Parameter Specification Actual Observation
By Sign
1. Pan load (36”) Approx. 14 kg
2. Inlet Temperature 55 ± 5 OC

3. Exhaust Temperature 40 ± 5 OC

4. Pan RPM ____± ____

____ ± ____ g /
5. Spray rate
minute / gun
6. Bed temperature 40 ± 4OC
7. No of spray guns 04
Diameter of the nozzle
8. 1.2 mm
of spray gun
Distance between
9. –––
tablet bed & nozzle

Remark:
----------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------

Reviewed by (Sign/Date)
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

INPROCESS CHECKS (Production)

Weight of 20
Tablets Disintegration Thickness
Time Checked
Date Appearance 13.872 g ± 2.5% 4.70  0.20 mm
Limit: NMT by
(13.526 – 14.218 30 minutes (4.50 mm – 4.90 mm)
g)

Uniformity of weight coated tablets 693.6 mg ± 5% ( 658.92 mg – 728.28 mg) – By

production
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg:
Checked by:

Remark:
----------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------

Reviewed by (Sign/Date)
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

INPROCESS CHECKS (QA)

Weight of 20
Disintegration Thickness
Tablets
Time 4.70  0.20 mm Checked
Date Appearance 13.872 g ± 2.5%
Limit: NMT 30 (4.50 mm – 4.90 by
(13.526 – 14.218 minutes mm)
g)

Uniformity of weight for coated tablets to be performed from different locations

Location - I
Uniformity of weight coated tablets 693.6 mg ± 5% (658.92 mg – 728.28 mg)– By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - II
Uniformity of weight coated tablets 693.6 mg ± 5% (658.92 mg – 728.28 mg)– By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - III
Uniformity of weight coated tablets 693.6 mg ± 5% (658.92 mg – 728.28 mg)– By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - IV
Uniformity of weight coated tablets 693.6 mg ± 5% (658.92 mg – 728.28 mg)– By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - V
Uniformity of weight coated tablets 693.6 mg ± 5% (658.92 mg – 728.28 mg)– By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

Location - VI
Uniformity of weight coated tablets 693.6 mg ± 5% (658.92 mg – 728.28 mg)– By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - VII
Uniformity of weight coated tablets 693.6 mg ± 5% (658.92 mg – 728.28 mg)– By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - VIII
Uniformity of weight coated tablets 693.6 mg ± 5% (658.92 mg – 728.28 mg)– By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

Location - IX
Uniformity of weight coated tablets 693.6 mg ± 5% (658.92 mg – 728.28 mg)– By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:

Location - X
Uniformity of weight coated tablets 693.6 mg ± 5% (658.92 mg – 728.28 mg)– By QA
Date: Time:
Tablet weight in mg
1 5 9 13 17
2 6 10 14 18
3 7 11 15 19
4 8 12 16 20
Min: Max: Average Weight in mg: Checked
by:
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

RESULTS OF MINIMUM CAPSULE SHAPE:

Checked By
Tests Acceptance Criteria Observation
Sign/Date
Pan capacity Determination According to the capacity as
specified by supplier
Visual Inspection Sample Uniform in appearance
20 tablets at each sampling
location.
Verify weight gain of The average wt. gain should
Tablet after coating. not be less than 1.5%.
Composite 20 tab let
Sample 10 location
Establish coater capacity Hardware and software to
with Hardware and perform without any
software to perform interruptions and trouble.
without any interruptions
and trouble.
Physical & chemical Weight Variation, Thickness,
characteristics Friability, Hardness, and
disintegration should be
within limits specified in PQ
BMR.

Remark :
----------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------

Checked By (Sign/Date)
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

10.7 Composite assay result of coated tablet

Collect the composite tablet for assay test from each lot of coating and send to QC for
analysis.

[Link]. Shape Quantity of Assay result Remark

sampled given
to QC
I. Round shape Maximum

II. Round shape Minimum

III. Oval shape Maximum

IV. Oval shape Minimum

V. Capsule shape Maximum

VI. Capsule shape Minimum

Remark :
----------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------

Checked By (Sign/Date)
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

11.0 DEFFICIENCY AND CORRECTIVE ACTIONS:

Following deficiency was verified and corrective actions taken in consultation with the validation
team.

Description of deficiency:

Corrective action(s) taken:

Deviation accepted by Deviation Approved by

(Sign/Date) (Sign/Date)
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

12.0 ANNEXURE (S):

[Link]. Annexure No. Title of Annexure

Remarks (if any):

---------------------------------------------------------------------------------------------------------------------

---------------------------------------------------------------------------------------------------------------------

Done By & Date: Verified By & Date:

 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

13.0 PERFORMANCE QUALIFICATION FINAL REPORT:

13.1 SUMMARY:

13.2 CONCLUSION:

Prepared By Checked By
Sign/Date Sign/Date
 PERFORMANCE QUALIFICATION PROTOCOL CUM PROTOCOL No.:
REPORT
FOR
AUTOCOATER
PHARMA DEVILS

13.3 FINAL REPORT APPROVAL:

It has been verified that all tests required by this report are completed, reconciled and attached to
this protocol or included in the performance qualification summary report. All amendments and
discrepancies are documented, approved and attached to this protocol. (If applicable)
Signature in the block below indicate that all items in this qualification report of Autocoater have
been reviewed and found to be acceptable and that all variations or discrepancies have been
satisfactorily resolved.

FUNCTION NAME DESIGNATION DEPARTMENT SIGNATURE DATE

QUALITY
ASSURANCE

ENGINEERING
REVIEWED
BY
QUALITY
CONTROL

PRODUCTION

HEAD
OPERATION
APPROVED
BY
QUALITY
ASSURANCE