ORIGINAL Confidential

SANMOL FORTE TABLET

PROCESS VALIDATION PROTOCOL

Document No. : VAL-PV/PVR/MB/068

Revision No. : 00

Date : 09 SEPTEMBER 2013

Product : SANMOL FORTE TABLET

Code : 01026
: PRO-ST/BRC/MB/087-SB; Rev. 00, PRO-
MS No.
ST/BRC/MB/088-SB; Rev. 00

TS No. : SP-OJ-S-600; Rev. 02

Site : PT. CAPRIFARMINDO LABORATORIES

7

Prepared by:

Function Name/Title Signature Date

Novita Purwanti /
Production
Process Validation Coordinator
Frisky Almuksiti /
Validation
Process Validation Engineer

Reviewed & Approved by:

Function Name/Title Signature Date
Khairudin /
Validation
Site Validation Coordinator
Herwanto/
R&D
Reviewed R&D Corp. General Manager
Quality Riny Yunita H. /
Control QC Manager PT. Caprifarmindo
Plant Andriana Martadiputra /
Manager Plant Manager PT. Caprifarmindo
Atiek Istiyawati B.M /
QA Manager PT. Caprifarmindo
Approved Quality
Sumardi /
Head of Quality

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SUMMARY

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TABLE OF CONTENTS
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SUMMARY.......................................................................................................................................2
1. OBJECTIVE................................................................................................................................5
2. SCOPE.........................................................................................................................................5
3. VALIDATION TEAM..................................................................................................................5
3.1. Team Member.....................................................................................................................5
3.2. Responsibilities...................................................................................................................5
3.2.1. Production Department...........................................................................................5
3.2.2. QC Department.......................................................................................................6
3.2.3. QA Department.......................................................................................................6
3.2.4. Validation Department............................................................................................6
3.2.5. R&D Department....................................................................................................6
3.2.6. Engineering Department.........................................................................................6
3.2.7. PPIC Department....................................................................................................7
4. PROCESS VALIDATION STAGE..............................................................................................7
4.1. Responsible Personel..........................................................................................................7
4.2. Starting Material..................................................................................................................7
4.2.1. Formula...................................................................................................................7
4.2.2. Specification & Test Procedure Number of Raw Material.....................................7
4.2.3. Specification & Test Procedure Number of Packaging Product.............................8
4.2.4. Specification & Test Procedure Number Finished Product.....................................8
4.2.5. Machines/ Equipments............................................................................................8
4.3. Room Condition..................................................................................................................8
4.4. Process Schematic Flow......................................................................................................9
4.5. Production Process, Critical Parameter, Testing Point and Analysis Method...................13
4.6. Sampling Plan...................................................................................................................13
4.6.1. Sampling in FBD Jaw Chuang..............................................................................13
4.6.2. Sampling in Super Mixer SM-150........................................................................14
4.6.3. Sampling During Tablet Pressing..........................................................................14
4.6.4. Sampling during Stripping....................................................................................15
4.7. Acceptance Criteria............................................................................................................16
5. CONCLUSION OF THE PROCESS VALIDATION................................................................16
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6. DISCUSSION...........................................................................................................................16
7. RECOMMENDATION.............................................................................................................16
8. DECISION................................................................................................................................16
9. PROPOSE OF REVALIDATION.............................................................................................16
10. LIST OF ENCLOSURE............................................................................................................16
11. DEVIATION REPORT..............................................................................................................17
12. REVISION HISTORY...............................................................................................................17

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1. OBJECTIVE
The aim of this validation is to ensure that the production process of SANMOL FORTE
Tablet base on the batch record for 120 kg batch size (batch size increased from 20 kg to
120 120 kg) will produce high degree quality product consistently.

2. SCOPE
This validation is dedicated for SANMOL FORTE Tablet that toll manufacturing product
from PT. Sanbe Farma to PT. Caprifarmindo Laboratories, Cimareme, Padalarang.

The scope of this validation for SANMOL FORTE Tablet covers mixing, granulating,
drying, compressing and stripping.

The validation process will be performed concurrently. This protocol is not allowed to be
change during execution.

3. VALIDATION TEAM
3.1. Team Member

Function Name / Title

Team Leader Andriana M. / Plant Manager PT. Caprifarmindo Labs
Coordinator Novita Purwanti / Process Validation Coordinator
R&D Herwanto / R&D Corp. General Manager
Riny Yunita. H / QC Manager PT. Caprifarmindo Labs
Quality Sumardi / Head of Quality
Atiek Istiyawati B.M / QA Manager PT. Caprifarmindo Labs
Engineering Ruchimat Yusuf / Engineering Manager
Khairudin / Site Validation Coordinator
Validation
Frisky Almuksiti / Validation Engineer
PPIC Purwantoro / PPIC Manager

3.2. Responsibilities
3.2.1. Production Department
Responsible for:
1. Preparing and maintaining the departmental procedures and operator
training programs, which are necessary to ensure that the developed and
implemented standards in the validation runs are followed properly during
routine production.
2. Ordering and maintaining adequate supplies of raw materials and packaging
components to be used for the validation process runs.
3. Preparation, set up and operation of machine and other necessary
production equipment and utensil.
4. Implementing any agreed recommendations that may be made as results of
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this study.
5. Conducting environmental monitoring of temperature and relative humidity
during validation process activity together with validation department.

3.2.2. QC Department
Responsible for:
1. Preparing all sampling and testing equipment.
2. Testing the samples according to validated analytical method.
3. Conducting investigation with production and validation if there is any out
of specification case.
4. Taking sample according to the sampling point mentioned in this protocol.
3.2.3. QA Department
1. Reviewing and approving validation protocol and report for SANMOL
FORTE Tablet.
2. Ensuring that cleaning validation activities conform with quality assurance
requirements.
3.2.4. Validation Department
Responsible for:
1. Preparing validation protocol and report for SANMOL FORTE Tablet.
2. Conducting validation process activities together with the designated
validation team members from Production, QC, R&D and Engineering
departments.
3. Conducting environmental monitoring of temperature and relative humidity
during validation process activity together with production department.
4. Conducting investigation with R&D, production and QC if there is any out
of specification case.
5. Ensuring that the validation process is executed as approved protocol
agreed.
3.2.5. R&D Department
Responsible for:
1. Preparing the batch record for SANMOL FORTE Tablet.
2. Preparing the product specification and analysis method.
3. Conducting investigation with Validation, production and QC if there is any
out of specification case.
3.2.6. Engineering Department
Responsible for:
1. Preparing all instruments and equipment needed in the validation process.
2. Preparing and maintaining required standard production operating
conditions and utilities.
3. Repairing and trouble shooting equipment/instrument in case of breakdown
or malfunction.
3.2.7. PPIC Department
Responsible for:
1. Preparing production planning includes validation batches.
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2. Maintaining adequate supplies of raw materials and packaging components

to be used for the validation process runs.

4. PROCESS VALIDATION STAGE

4.1. Responsible Personnel
Personnel who are responsible for each step of production process is attached in
attachment 1.
4.2. Starting Material
4.2.1. Formula
Batch Size: 120 kg for 150,000 tablets
Acetaminophen Powder 97.500 kg
Microcrystalline Cellulose 102 qs ad 120 kg 0.720 kg
Croscarmellose Sodium 3.600 kg
Hydroxypropyl Cellulose LM 3.600 kg
Pigment Yellow No. 5 FDC 0.060 kg
Maize Starch 6 kg
Methylparaben 0.084 kg
Propylparaben 0.036 kg
Purified Water 55 Liter
Croscarmellose sodium 3.600 kg
Talc 1.200 kg
Silicon dioxide colloidal 2.400 kg
Magnesium stearate 1.200 kg
4.2.2. Specification & Test Procedure Number of Raw Material.

Raw Material Code Specification

Acetaminophen Powder CP01000223 SP-BB- 061; Rev. 05
Microcrystalline Cellulose 102 qs ad 120 kg CP05000015 SP-BB-M-038; Rev. 05
Croscarmellose Sodium CP05000178 SP-BB- 174; Rev. 03
Hydroxypropyl Cellulose LM CP05000220 SP-BB-H-052; Rev. 05
Pigment Yellow No. 5 FDC CP03000285 SP-BB-T-151; Rev. 05
Maize Starch CP05000270 SP-BB-C-079; Rev. 03
Methylparaben CP05000106 SP-BB-M-004; Rev. 04
Propylparaben CP05000107 SP-BB-P-003; Rev. 04
Purified Water CP08000130 SP-BB-P-429; Rev. 02
Talc CP05000153 SP-BB-T-002; Rev. 05
Silicon Dioxide Colloidal CP05000002 SP-BB-C-123; Rev. 05
Magnesium Stearate CP05000100 SP-BB- 001; Rev. 05
4.2.3. Specification & Test Procedure Number of Packaging Materials

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Packaging Material Code Specification

PL2) SANMOL FORTE TABLET (150

CP51000476 SP-BK-P-600; Rev. 00
mm/12 µ PT3)
PL 2) Silver Dull 150 mm/12 µ PT3) CP51000292 SP-BK-P-048; Rev. 00
Folding box SANMOL FORTE TABLET CP55000643 SP-BK-F-600; Rev.00
Brochure SANMOL FORTE TABLET CP54000574 SP-BK-B-600; Rev.00
Master box (D1011-1) CP56000037 SP-BK-M-020; Rev.00
Security Seal Tape 12 mm “SANBE” CP59000024 SP-BK-S-003; Rev.01
Paper plaster 2” CP59000021 SP-BK-P-006; Rev.00

PL = Polycellonium
PT = Plain Transparant

4.2.4. Specification & Test Procedure Number Finished Product

Product Specification & Test

Finished Product
Code Procedure Number
SANMOL FORTE TABLET 01026 SP-OJ-S-600; Rev. 02

4.2.5. Machines/ Equipments

Calibration and qualification of machines/equipments used in production
process are attached in the attachment 2.

4.3. Room Condition

The environment monitoring results form during processing is attached in the
attachment 3.

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4.4. Process Schematic Flow

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4.5. Production Process, Critical Parameter, Testing Point and Analysis Method

Manufacturing Critical Analysis

Starting Material Equipment Testing Point
Step Parameter Method
 Acetaminophen Weighing Electronic Quantity - Calibration label/ N/A
Powder (97.500 kg) Process (1) Balance Accuracy: certificate
Mettler -Balance checking
 Microcrystalline
Toledo Calibration - The weighing
Cellulose 102 qs ad -Actual result
120 kg (0.720 kg) Weight verification by
 Croscarmellose second person
Sodium (3.600 kg)
 Hydroxypropyl
Cellulose LM
(3.600 kg)
 Pigment Yellow No. 5
FDC (0.060 kg)
 Maize Starch (6 kg)
 Methylparaben
(0.084 kg)
 Propylparaben
(0.036 kg)
 Purified water
(55 Liter)
 Croscarmellose
Sodium (3.600 kg)
 Talc (1.200 kg)
 Silicon Dioxide
Colloidal (2.400 kg)
 Magnesium Stearate
(1.200 kg)
 Acetaminophen Sieving (2A) Screen 2 mm Particle size Visually
Powder (97.500 kg)
 Microcrystalline
Cellulose 102 qs ad Sieving (2B)
120 kg (0.720 kg) Granulator
 Croscarmellose Jaw Chuang
Sodium (3.600 kg) Sieving (2C) OG

 Pigment Yellow No. 5

FDC Sieving (2D) Stainless Mesh 80
(0.060 kg) Steel Sifter Mesh 30
 Croscarmellose
Sodium (3.600 kg)

 Croscarmellose
Sodium (3.600 kg) Sieving (2E) Granulator Screen 2 mm
 Talc (1.200 kg) Jaw Chuang
OG
 Silicon Dioxide
Colloidal (2.400 kg)

 Magnesium Stearate
Sieving (2F) Stainless Mesh 30
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Manufacturing Critical Analysis

Starting Material Equipment Testing Point
Step Parameter Method
(1.200 kg) Steel Sifter

 Sieved material 1 st Mixing (3) Super Speed : 95 Homogeneity Visually

from step 2A, 2B, 2C, Mixer rpm
2D (SM-150) Time : 20
minutes
 Suspension Mucilage Container N/A Soluble Visually
preparation Preparation (4) Good mucillago
Purified Water 6 Liter
Maize Starch 6 kg

 Preservatives Solution
preparation
Hot Purified Water 24
Liter
Methylparaben
(0.084 kg)
Propylparaben
(0.036 kg)
 Mixed material Wet granulating Super Granulating 1 Good wet masses Visually
step 3 (5) Mixer Agitator
 Mucilage from (SM-150) speed :
step 4
95 – 98 rpm
Chopper
speed :
450 – 460
rpm
Time : 10
minutes
Granulating 2
Agitator
Purified Water 3 Liter speed :
95 – 98 rpm
Chopper
speed :
450 – 460
rpm
Time : 5
minutes
Granulating 3
Agitator
 Purified Water speed :
3 Liter 95 – 98 rpm
Chopper
speed :
820 – 840
rpm
Time : 5
minutes

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Manufacturing Critical Analysis

Starting Material Equipment Testing Point
Step Parameter Method
Granulating 4
Agitator
speed :
 Purified Water
95 – 98 rpm
3 Liter
Chopper
speed :
820 – 840
rpm
Time : 5
minutes
Granulating 5
Agitator
speed :
95 – 98 rpm
 Purified Water
6 Liter Chopper
speed :
820 – 840
rpm
Time : 5
minutes
 Material from Sieving (6) Granulator Screen 10 Particle size Visually
step 5 Jaw Chuang
OG
 Material from Drying (7) FBD Jaw  Interval Air Moisture content Moisture
step 6 Chuang temperature ≤ 3.0 % content analyser
: 10 min
 Exhaust
Temperature
: 45 °C
 Hot air
temperature
: 60 °C
 Interval
shaking
: 30 sec
 Dried material Sieving (8) Granulator Screen 2 mm Particle size Visually
step 7 Jaw Chuang
OG
 Sieved material 2nd Mixing (9) Bohle  Speed : 6 Homogeneity Visually
from step 2C rpm
 Sieved material  Time : 10
step 8
minutes
 Sieved material 3rd Mixing (10) Bohle  Speed : 6 - Appearance, Visually,
from step 2D rpm color, taste, organoleptic
 Mixed Material odor
 Time : 5
from step 9 - Identification Spectrofotometer
minutes - Assay Spectrofotometer
 Mixed material Compressing Tablet Press Machine Appearance Visual
from step 10 (11) Machine speed (form, color, Organoleptic
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Manufacturing Critical Analysis

Starting Material Equipment Testing Point
Step Parameter Method
Compressing odor, sign)
Force Diameter Diameter tester
Thickness Thickness tester
Weight Electronic
balance
Friability Friability tester
Hardness Hardness Tester
Disintegration Disintegration
time tester
Identification of Spectrofotometer
Acetaminophen
Dissolution of Dissolution tester
Acetaminophen HPLC
Related
Subtances RSD calculation
Uniformity of
dosage units Spectrofotometer
Assay of
Acetaminophen
 Tablets from Stripping (12) Stripping Roller Appearance Visually
step 11 Machine temperature Leak test Vacuum
 Polycellonium chamber
Finished
 Tablet in strip Described in SOP No. SP-OJ-600 Rev. 01
Product Testing

4.6. Sampling Plan

4.6.1. Sampling in FBD Jaw Chuang
The samples in FBD Jaw Chuang are taken after drying process is completed. The
samples are taken from the bottom (2 sampling points), middle (4 sampling points)
and top (4 sampling points) which the sample quantity is 5 g respectively. Each
sample is tested its moisture content.

D
B

C
E
H
F
G
I

Picture 1. Sampling Point in FBD Jaw Chuang

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4.6.2. Sampling in Super Mixer SM-150

The samples of bulk product in the Super Mixer SM-60 are taken after the mixing
process with lubricant is completed. The granules samples are taken from the top (2
sampling points), middle (2 sampling points) and bottom (2 sampling points) which
the sample quantity is 15 g respectively. Each sample is analysed its Acetaminophen
concentration. The sampling point in the Super Mixer SM-60 is shown below:

Picture 2. Sampling Point in Container Super Mixer SM-60

4.6.3. Sampling During Tablet Pressing

Sampling during tablet pressing process is divided to be 10 sampling points. The
samples are used for dimension, thickness, hardness, friability, disintegration,
uniformity of dosage unit and assay testing of the tablet. The sampling points and the
samples quantity are shown below :
1. In the beginning of the tablet pressing process, take samples:
 10 tablets as samples for thickness test, weight uniformity and hardness testing
and marked “A”.
 16 tablets as samples for friability and disintegration time and marked
“Beginning”.
 tablets as samples for assay, uniformity of dosage unit testing and dissolution
testing and marked “Beginning”.
2. After tablet pressing machine produce 2,500 tablets, take samples:
 10 tablets for thickness test, weight uniformity and hardness testing and
marked “B”.
3. After tablet pressing machine produce 5,000 tablets, take samples:
 10 tablets for thickness test, weight uniformity and hardness testing and
marked “C”.
4. After tablet pressing machine produce 7,500 tablets, take samples:
 10 tablets for test, weight uniformity and hardness testing and marked “D”.
5. After tablet pressing machine produce 10,000 tablets, take samples:
 10 tablets for thickness test, weight uniformity and hardness testing and
marked “E”.
6. After tablet pressing machine produce 12,500 tablets, take samples:

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 10 tablets as samples for thickness test, weight uniformity and hardness testing
and marked “F”.
 16 tablets as samples for friability and disintegration time and marked
“Middle”.
 42 tablets as samples for assay, uniformity of dosage unit testing and
dissolution testing and marked ‘Middle”.
7. After tablet pressing machine produce 15,000 tablets, take samples:
 10 tablets for thickness test, weight uniformity and hardness testing and
marked “G”.
8. After tablet pressing machine produce 17,500 tablets, take samples:
 10 tablets for thickness test, weight uniformity and hardness testing and
marked “H”.
9. After tablet pressing machine produce 20,000 tablets, take samples:
 10 tablets for thickness test, weight uniformity and hardness testing and
marked “I”.
10. After tablet pressing machine produce 22,500 tablets, take samples:
 10 tablets as samples for thickness test, weight uniformity and hardness testing
and marked “J”.
 16 tablets as samples for friability and disintegration time and marked “End”.
 42 tablets as samples for assay, uniformity of dosage units testing and
dissolution testing and marked “End”.

4.6.4. Sampling during Stripping

Sampling during stripping process is divided to 9 sampling points for leak testing
during stripping process. Total sample that must be taken for leak testing with batch
size 150,000 tablets is 500 tablets (Military Standard). The sample quantity for each
sampling point is 60 stripped tablets. The test is performed during stripping process
as a part of In Process Control. The sampling points and the samples quantity are
shown below:
1. In the beginning of the stripping process is taken 60 stripped tablets as samples.
2. After stripping machine produce 15,000 of stripped tablets, 60 stripped tablets are
taken as samples.
3. After stripping machine produce 30,000 of stripped tablets, 60 stripped tablets are
taken as samples.
4. After stripping machine produce 45,000 of stripped tablets, 60 stripped tablets are
taken as samples.
5. After stripping machine produce 60,000 of stripped tablets, 60 stripped tablets are
taken as samples.
6. After stripping machine produce 75,000 of stripped tablets, 60 stripped tablets are
taken as samples.
7. After stripping machine produce 90,000 of stripped tablets, 60 stripped tablets are
taken as samples.
8. After stripping machine produce 105,000 of stripped tablets, 60 stripped tablets
are taken as samples.
9. After stripping machine produce 120,000 of stripped tablets, 60 stripped tablets
are taken as samples.

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4.7. Acceptance Criteria

Acceptance criteria or each critical parameter can be seen in attachment 12.

5. CONCLUSION OF THE PROCESS VALIDATION

..........................................................................................................................................................................................
..........................................................................................................................................................................................
..........................................................................................................................................................................................
..........................................................................................................................................................................................
..........................................................................................................................................................................................

6. DISCUSSION
..........................................................................................................................................................................................
..........................................................................................................................................................................................
..........................................................................................................................................................................................
..........................................................................................................................................................................................
..........................................................................................................................................................................................

7. RECOMMENDATION
..........................................................................................................................................................................................
..........................................................................................................................................................................................
..........................................................................................................................................................................................
..........................................................................................................................................................................................
..........................................................................................................................................................................................

8. DECISION
..........................................................................................................................................................................................
..........................................................................................................................................................................................
..........................................................................................................................................................................................
..........................................................................................................................................................................................
..........................................................................................................................................................................................

9. PROPOSE OF REVALIDATION
Revalidation is performed if there is change of;
1. Formulation
2. Batch size (if more than 25 % of previous batch)
3. Manufacturing process
4. Equipment
5. Primary packaging material

10. LISTS OF ENCLOSURE

1. Attachment 1 Responsible Personnel

2. Attachment 2 Machines/ Equipments Qualification
3. Attachment 3 Room Monitoring Result
4. Attachment 4 Weighing Process Record
5. Attachment 5 Sieving Process Record

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6. Attachment 6 1st Mixing Process Record

7. Attachment 7 Wet Granulating and Wet Granules Sieving Process Record
8. Attachment 8 Granules Drying and Dried Granules Sieving Process Record
9. Attachment 9 2nd and 3rd Mixing Process Record
10. Attachment 10 Tablet Pressing Process Record
11. Attachment 11 Stripping Process Record
12. Attachment 12 Acceptance Criteria
13. Attachment 13 Process Validation Result
14. Attachment 14 Calculation

11. DEVIATION REPORT

Any deviation from the validation report has to be reported to the validation team and recorded.
Any revise from the validation protocol based on the deviation must be approved by the
validation team.
DEVIATION REPORT

Name of Validation:

Deviation description
Proposal to close the
deviation
Discussion and
conclusion
Reported by Reviewed by Approved by

( ) ( ) ( )

12. REVISION HISTORY

Revision
Date Description Originator
No.
00 09 September 2013 Initial Release Frisky Almuksiti

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