PROCESS VALIDATION PROTOCOL

FOR SANFULIQ FILM-COATED CAPLET

Document No. : VAL-PV/PVP/MB/089-R

Date :

I. Product description
Name : SANFULIQ FILM-COATED CAPLET
Code : 02087
Dosage forms : FILM COATED CAPLET
Batch Size : 120 kg for 150,000 caplets (Production Scale)
Manufacturing site : PT. CAPRIFARMINDO LABORATORIES
(Pharmaceutical Plant)
Jl. Industri Cimareme No. 8 Block H
Kabupaten Bandung Barat - Indonesia

Compiled by:
II. Prepared by:
Function Name/Title Signature Date
Production
Novita Purwanti /
Process Validation Coordinator
Giva Olviana Yudhista /
Validation
Process Validation Engineer

III. Reviewed & Approved by:

Function Name/Title Signature Date
Mukti Wibowo /
Validation
Site Validation Coordinator
Herwanto /
R&D
Reviewed R&D Corp. General Manager
Quality Riny Yunita H. /
Control QC Manager
Khairudin /
Plant Manager
Plant Manager
Lutfi Febrina /
QA Manager
QA Manager
Approved
Head of Sumardi /
Quality Head of Quality
I. Objective
- Mixing process validation of caplet by conducting observation on the granule’s
appearance (color, odor), moisture content, identification and assay.
- Compressing process validation of caplet by conducting observation on the
caplet appearance (form, color, odor, sign), length, width, thickness, weight,
weight variation, hardness, friability, disintegration, identification and assay.
- Coating process validation of caplet by conducting observation on the coated
caplet appearance (form, color, odor, sign), weight, disintegration, water
content, microbial enumeration, heavy metal, identification and assay.
- Stripping process validation by conducting the leak test.

II. Scope
- Validation is conducted on three batches of SANFULIQ FILM-COATED
CAPLET that is manufactured consecutively.
- Inspection is performed on preparation and raw material mixing process.
- Inspection on the compressing process.
- Inspection on the coating process.
- Inspection on the stripping process.
- Validation process includes:
1. Production process
2. Sampling process
2.1. Sampling after Mixing Process
The process sampling were taken after mixing process is completed.
The samples were taken in the final mixing from Top, Middle and
Bottom. The samples are tested for appearance (color, odor), moisture
content, identification and assay.
Sampling point is shown below:

A
Top B D
C

Middle 1
E F G

Middle 2 H I

Bottom J

2.2. Sampling during Tablet Pressing

Sampling during tablet pressing process is divided to be 10 sampling
points. The samples are tested for caplet appearance (form, color,
odor, sign), length, width, thickness, weight, weight variation,
hardness, friability, disintegration, identification and assay.
 2.3. Coating Process
Each sample is tested for caplet appearance (form, color, odor, sign),
weight, disintegration, water content, microbial enumeration, heavy
metal, identification and assay.

2.4. Stripping process

Samples are used for leakage test.

3. Operational data recording

4. Critical parameters test
5. Data collecting
6. Evaluation and report

This validation protocol is dedicated for SANFULIQ FILM-COATED CAPLET

that produced in PT CAPRIFARMINDO LABORATORIES, Cimareme,
Padalarang.

III. Formula
Batch Size: 120 kg for 150,000 caplets

Weight Weight
Raw Material Vendor of Material
(per batch) (per caplet)
Curcuma Domestica 22.500 kg 150 mg
Powder Extract
Silybin phospholipids 21 kg 140 mg
Schizandra Berry Powder 20.250 kg mg
Extract
Choline Bitartrate 22.500 kg 135 mg
Pyridoxine Hydrochloride 0.451200 kg 3.008 mg
97 % granule
Thiamine Hydrochloride 0.218636 kg 1.457573 mg
Riboflavin 0.198 kg 1.32 mg
Cyanocobalamin 0.1 % 0.432 kg 2.88 mg
Dry Vitamin E Acetate 50 5.184 kg 34.56 mg
%
L-HPC LH 11 3 kg 20 mg
L-HPC LH 11 3 kg 20 mg
Crospovidone 6 kg 40 mg
Silicon Dioxide Colloidal 1.200 kg 8 mg
Talc 0.600 kg 4 mg
Talc 0.600 kg 4 mg
Magnesium Stearate 0.300 kg 2 mg
Magnesium Stearate 0.300 kg 2 mg
Pregelatinized Starch 6.144 kg 40.96 mg
Pregelatinized Starch qs ad 6.122164 kg 40.81443 mg
120 kg
Core caplets :
 Coating solution :
Weight Weight
Raw Material Vendor of Material
(per batch) (per caplet)
Hydroxypropyl
Methylcellulose 2910 4.800 kg 32 mg
Viscosity 6 cps
Polyethylene Glycol 6000 0.535200 kg 3.568 mg
Talc 1.171200 kg 7.808 mg
Titanium Dioxide 0.596400 kg 3.976 mg
Ethylcellulose N.10 2.558400 kg 17.056 mg
Pigment Yellow No.6 FDC 0.134400 kg 0.896 mg
Methylene Chloride 60 L 0.4 mL
Ethyl Alcohol 60 L 0.4 mL

IV. Description on Process

See attachment 1 Schematic Flow Process Table and Attachment 2 Schematic
Flow Process Diagram.

V. Room Monitoring
See attachment 3 Room Monitoring Result

VI. Equipment Qualification

See attachment 4 Equipment Qualification

VII. Manufacturing Process

Stage 1. Raw Material Sieving Process
- 1st Sieving
Mix Silicon Dioxide Colloidal and Pregelatinized Starch within 5 minutes in
plastic bag 5 kg, then sieve with Powder Siever mesh 30.
- 2nd Sieving
Sieve Curcuma Domestica Powder Extract, Schizandra Berry Powder Extract,
Crospovidone, L-HPC LH-11, and Talc with Powder Siever mesh 30.
- 3rd Sieving
Sieve Choline Bitartrate with powder sifter mesh 20 and then put into Bohle.
- 4th Sieving
Sieve Magnesium Stearate with stainless steel mesh 30.
- 5th Sieving
Mix Pregelatinized Starch, Pyridoxine Hydrochloride 97% Granule, Thiamine
Hydrochloride, Riboflavin, Cyanocobalamin 0.1% within 5 minutes in plastic
bag 5 kg and then sieve with powder sifter mesh 30.
- 6th Sieving
Sieve Dry Vitamin E Acetate 50 % with Powder siever mesh 20.
- 7th Sieving
Sieve L-HPC LH 11 with Powder siever mesh 30.
- 8th Sieving
Sieve Talc with Powder siever mesh 30.
- 9th Sieving
Sieve Silybin Phospholipids with Powder siever mesh 30.
- 10th Sieving
 Sieve Magnesium Stearate with stainless steel mesh 30.
Write down the process data in attachment 5, Critical Parameter Result During
Process.

Stage 2. Mixing, Slugging, and Sieving Process

- 1st Mixing Process
Mix sieved materials from stage 1 step 1st Sieving, 2nd Sieving, and 3rd Sieving
in Bohle (mixer speed: 6 rpm; mixing time: 25 minutes).
- 2nd Mixing Process
Mix sieved material from stage 1 step 4 th Sieving and mixed material from
stage 2 1st Mixing Process in Bohle (mixer speed: 6 rpm; mixing time: 5
minutes).
- 3rd Slugging Process
Slug mixed material from stage 2 step 2nd using Manesty D4 (hadness: 5-8
kg/cm2, length: 16.6 mm, and width: 8.6 mm).
- 4th Slugg Sieving Process (Mass A)
Sieve slugg from stage 2 step 3rd with Granulator STC mesh 12 in to plastic
bag (MASS A)
- 5th Mixing Process
Mix mass A, mass B, sieved material from Stage 1 step 5th, 6th, 7th, 8th, and 9th
with layering step (can be seen at attachment 2 Schematic Flow Process) in
Bohle (mixer speed: 6 rpm, mixing time 25 minutes).
- 6th Final Mixing Process
Mix sieved material from stage 1 step 10th and mix material from stage 2 step
5th in Bohle (mixer speed: 6 rpm, mixing time 5 minutes). Samples are
analysed for the granule’s appearance (color, odor), moisture content,
identification and assay.

Write down the process data in attachment 5, Critical Parameter Result During
Process.

Stage 3. Compressing Process

Compress bulk product with Manesty D4. Samples are analysed for the caplet
appearance (form, color, odor, sign), length, width, thickness, weight, weight
variation, hardness, friability, disintegration, identification and assay. Write
down the process data in attachment 5, Critical Parameter Result During
Process.

Stage 4. Preparation for Coating Solution

Stage 5. Coating Process

Coat caplet product with Coating Thai Coater. Samples are analysed for the
coated caplet appearance (form, color, odor, sign), weight, disintegration, water
content, microbial enumeration, heavy metal, identification and assay. Write
down the process data in attachment 5, Critical Parameter Result During
Process.

Stage 6. Stripping Process

Strip caplet from stage 4. Test result for stripped caplet is leakage test.
VIII. Acceptance criteria
- Validation is considered to be accepted and valid if all the obtained
evaluation result complies with the compendia or internal specification.
- All evaluation parameters mentioned in the attachment is conducted

IX. Evaluation Failure

If one or more obtained evaluation result does not comply with acceptance
criteria, further action should be proposed by the protocol makers to the
production department and validation executors and approved by the officers who
have signed the protocol.

X. Revalidation Review
Revalidation is performed if there is a change of:
1. Formulation
2. Batch size (if more than 25% of previous batch)
3. Manufacturing process
4. Equipment
5. Primary packaging material
 ATTACHMENT 1
SCHEMATIC FLOW PROCESS TABLE
IN MANUFACTURING OF SANFULIQ FILM-COATED CAPLET

Manufacturing Critical
Starting Material Equipment Testing Point Analysis Method
Step Parameter
Core Caplet Weighing Electronic Quantity - Calibration label/ N/A
 Curcuma Domestica Process (1) Balance Accuracy: certificate
Powder Extract METTLER -Balance checking
TOLEDO Calibration - the weighing
22.500 kg
-Actual Weight result verification
 Silybin phospholipids by second person
21 kg
 Schizandra Berry
Powder Extract
20.250 kg
 Choline Bitartrate
22.500 kg
 Pyridoxine
Hydrochloride 97 %
granule 0.451200 kg
 Thiamine
Hydrochloride
0.218636 kg
 Riboflavin 0.198 kg
 Cyanocobalamin
0.1% 0.432 kg
 Dry Vitamin E
Acetate 50 %
5.184 kg
 L-HPC LH 11
3 kg
 L-HPC LH 11
3 kg
 Crospovidone
6 kg
 Silicon Dioxide
Colloidal 1.200 kg
 Talc 0.600 kg
 Talc 0.600 kg
 Magnesium Stearate
0.300 kg
 Magnesium Stearate
0.300 kg
 Pregelatinized Starch
6.144 kg
 Pregelatinized Starch
 Manufacturing Critical
Starting Material Equipment Testing Point Analysis Method
Step Parameter
qs ad 30 kg 6.122164
kg

FILM COATING
SUSPENSION
 Hydroxypropyl
Methylcellulose 2910
Viscosity 6 cps 4.800
kg
 Polyethylene Glycol
6000 0.535200 kg
 Talc

1.171200 kg
 Titanium Dioxide
0.596400 kg
 Ethylcellulose N.10
2.558400 kg
 Pigment Yellow No.6
FDC 0.134400 kg
 Methylene Chloride
60 L
 Ethyl Alcohol 60 L
 Silicon Dioxide Raw Materials Mix manually Mixing time: 5 Homogeneity Visually
Colloidal 1.200 kg Sieving (2A) in plastic bag minutes Particle Size
5 kg
 Pregelatinized Starch
Powder siever
qs ad 30 kg 6.122164 Mesh size: mesh
kg 30
 Curcuma Domestica Raw Materials Powder siever Mesh size: mesh Homogeneity Visually
Powder Extract Sieving (2B) 30 Particle Size
22.500 kg
 Schizandra Berry
Powder Extract
20.250 kg
 L-HPC LH 11 3 kg
 Talc 0.600 kg
 Choline Bitartrate Raw Materials Powder siever Mesh size: mesh Particle Size Visually
22.500 kg Sieving (2C) 20
 Magnesium Stearate Raw Materials Stainless steel Mesh size : Particle Size Visually
0.300 kg Sieving (2D) sieve mesh 30
 Manufacturing Critical
Starting Material Equipment Testing Point Analysis Method
Step Parameter
 Pyridoxine Raw Materials Mix manually Mixing time: 5 Homogeneity Visually
Hydrochloride 97 % Sieving (2E) in plastic bag minutes Particle Size Visually
5 kg
granule 0.451200 kg
(MASS B)
 Thiamine Powder siever
Hydrochloride Mesh size: mesh
0.218636 kg 30
 Riboflavin 0.198 kg
 Cyanocobalamin
0.1 % 0.432 kg
 Pregelatinized
Starch 1.536 kg

 Dry Vitamin E Raw Materials Powder siever Mesh size: mesh Particle Size Visually
Acetate 50 % 5.184 Sieving (2F) 20
kg

 L-HPC LH 11 3 kg Raw Materials Powder siever Mesh size: mesh Particle Size Visually
Sieving (2G) 30

 Talc 0.600 kg Raw Materials Powder siever Mesh size: mesh Particle Size Visually
Sieving (2H) 30

 Silybin phospholipids Raw Materials Powder siever Mesh size: mesh Particle Size Visually
21kg Sieving (2I) 30

 Magnesium Stearate Raw Materials Stainless stell Mesh size : Particle Size Visually
0.300 kg Sieving (2J) sieve mesh 30

 Sieved materials from 1st Mixing Bohle Mixing time: 25 Homogeneity Visually
step 2A Process (3) minutes
 Sieved materials from
step 2B Machine speed:
 Sieved materials from 6 rpm
step 2C

 Materials from step 3 2nd Mixing Bohle Mixing time: 5 Homogeneity Visually
 Sieved materials Process (4) minutes
from step 2D
Machine speed:
6 rpm

 Mixed materials from Slugging Process Manesty D4 Mixing speed - Hardness - Hardness tester
step 4 (5) Tablet Compression - Calipers
Compressing force - Length and
Machine Width

 Slugging material from Sieving (6) Granulator Mesh size: mesh Particle Size Visually
step 5 (MASS A) STC 12
 Manufacturing Critical
Starting Material Equipment Testing Point Analysis Method
Step Parameter
 1/3 of materials from rd
3 Mixing Bohle Mixing time: 25 Homogeneity Visually
step 6 (MASS A) Process (7) minutes
 1/3 of materials from Machine speed:
step 2E (MASS B) 6 rpm
 1/3 of materials from
step 6
 Sieved materials from
step 2F
 1/3 of materials from
step 2E
 1/3 of materials from
step 6 (MASS A)
 Sieved materials from
step 2G
 Sieved materials from
step 2H
 1/3 of materials from
step 2E
 Sieved materials from
step 2I
 Sieved materials from 4th Mixing Bohle Mixing time: 5 Homogeneity Visually
step 2J Process (8) minutes Appearance (color, Visually
 Mixed materials from Machine speed: odor)
step 7 6 rpm Identification:
- Curcuma longa Spectrofotometry
rhizome extract UV-Visible
- Silybin TLC
phospholipids
- Schizandrae TLC
fructus extract
- Choline L- Presipitations
bitartrate
- Vitamin B1 HPLC
- Vitamin B2 HPLC
- Vitamin B6 HPLC
- Vitamin E HPLC
Assay of :
- Vitamin B1 HPLC
- Vitamin B2 HPLC
- Vitamin B6 HPLC
- Vitamin E HPLC
Moisture content Moisture Balance
 Manufacturing Critical
Starting Material Equipment Testing Point Analysis Method
Step Parameter
 Mixed materials from Compressing (9) Manesty D4 Machine Speed Appearance Visually
step 8 Compressing (Form, Color, & Organoleptic
force Odor, Sign)
Thickness Thickness tester
Lenght & Width Calipers

Weight & Weight Electronic Balance

variation
Hardness tester
Hardness Friability tester
Friability Disintegration
Disintegration tester

Identification: Spectrofotometry
- Curcuma longa UV-Visible
rhizome extract TLC
- Silybin
phospholipids TLC
- Schizandrae
fructus extract Presipitations
- Choline L-
bitartrate HPLC
- Vitamin B1 HPLC
- Vitamin B2 HPLC
- Vitamin B6 HPLC
- Vitamin E

Assay of: HPLC

- Vitamin B1 HPLC
- Vitamin B2 HPLC
- Vitamin B6 HPLC
- Vitamin E
Preparation of Coating Solution
COATING Weighing (10) Electronic Quantity - Calibration label/ N/A
SOLUTION: Balance Accuracy: certificate
-Balance checking
 Hydroxypropyl
Calibration - the weighing
Methylcellulose 2910 -Actual Weight result verification
Viscosity 6 cps 4.800 by second person
kg
 Polyethylene Glycol
6000 0.535200 kg
 Talc 1.171200 kg
 Titanium Dioxide
0.596400 kg
 Ethylcellulose N.10
2.558400 kg
 Pigment Yellow No.6
FDC 0.134400 kg
 Methylene Chloride
 Manufacturing Critical
Starting Material Equipment Testing Point Analysis Method
Step Parameter
60 L
 Ethyl Alcohol 60 L
 Ethyl alcohol 25 L Mixing (11) Silverson high Machine Speed: Homogeneity Visually
 Methylene chloride 25 shear 20 - 25 Hz
L Mixing time: 5
minutes

Preparation of Granule



 16 liters of mixed Mixing (12) Silverson high Machine Speed: Homogeneity Visually
material from step shear 50 Hz
11 (solvent) Mixing time: 15
 Hydroxypropyl minutes
Methylcellulose
2910 viscocity 6 cps
2kg
 2 liters of mixed Mixing (13) Silverson high Machine Speed: Homogeneity Visually
material from step shear 50 Hz
11 (solvent) Mixing time: 15
 Ethylcellulose N.10 minutes
1.066 kg
 8 liters of mixed Mixing (14) Silverson high Machine Speed: Homogeneity Visually
material from step shear 50 Hz
11 (solvent) Mixing time: 15
 Polyethylene glycol minutes
6000 223 gram
 8 liters of mixed Mixing (15) Silverson high Machine Speed: Homogeneity Visually
material from step shear 50 Hz
11 (solvent) Mixing time: 15
 Talc 448 gram minutes
 Titanium dioxide
248.5 gram
 Pigment yellow
No.6 56 gram
 Mixed material from Mixing (16) Silverson high Machine Speed: Homogeneity Visually
step 13 shear 50 Hz
 Mixed material from Mixing time: 15
step 14 minutes
 Mixed material from
step 15
 Solvent 16 L
Preparation of Coating Solution
 Manufacturing Critical
Starting Material Equipment Testing Point Analysis Method
Step Parameter
 Uncoat caplet from Coating process Coating Coating Pan - Appearance Visually
step 9 (17) Machine Thai Rotation - Color Visually
 Coating solution from coater - Odor Organoleptic
step 16 - Thickness Thickness tester
- Sign Visually
- Weight Balance
- Hardness Hardness tester
- Water content Karl Fisher
- Heavy metal of:
Plumbum (Pb) AAS
Cadmium (Cd)
Arsen (As)
Hydragyrum
(Hg)
 Coated Caplet Stripping Chen tai Leak test Appearance Vacuum chamber
from step 17 process (18) Stripping Leakage
 Polycellonium Machine
 ATTACHMENT 2
PROCESS SCHEMATIC FLOW
 ATTACHMENT 3
ROOM MONITORING RESULT

BATCH :
Relative Humidity 40-70% Temperature
Room Inspection by/Date Note
and 15-35% 18-26°C

Weighing

Temperature
Room Relative Humidity 15-35% Inspection by/Date Note
18-26°C

Mixing
Temperature
Room Relative Humidity 15-35% Inspection by/Date Note
18-26°C
Compressing
Temperature
Room Relative Humidity 40-70% Inspection by/Date Note
18-26°C
Coating
Temperature
Room Relative Humidity 40-70% Inspection by/Date Note
18-26°C
Stripping

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 ATTACHMENT 4
QUALIFICATION OF EQUIPMENTS

QUALIFICATION OR
CALIBRATION CHECK BY
NO EQUIPMENTS BRAND & TYPE REMARKS
& DATE
NUMBER DATE
Electronic Balance cap. METTLER TOLEDO –
1
300 g PL303
Electronic Balance cap. METTLER TOLEDO –
2
6 kg MonoBloc

3 Powder Sifter Lao Soung

4 Drum Mixer PHARMA TEKNIK

5 Granulator Granulator STC
6 Tablet Press Manesty D4
7 Coating machine Thai coater
8 Stripping machine Chentai 1

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 ATTACHMENT 5
CRITICAL PARAMETER RESULT DURING PROCESS

Critical Acceptance Actual Actual Actual

Mfg. Stage Pass/Fail
Parameter Criteria BN : BN : BN :
Step 2A
 Mixing Time  5 minutes
 Mesh Size  Mesh 30
Step 2B
Mesh Size Mesh 30
Step 2C
Mesh Size Mesh 30
Step 2D
Mesh Size Mesh 30
Step 2E
Sieving and
 Mixing Time  5 minutes
Mixing
Process  Mesh Size  Mesh 30
Step 2F
Mesh Size Mesh 20
Step 2G
Mesh Size Mesh 30
Step 2 H
Mesh Size Mesh 30
Step 2I
Mesh Size Mesh 30
Step 2J
Mesh Size Mesh 30
 Critical Acceptance Actual Actual Actual
Mfg. Stage Pass/Fail
Parameter Criteria BN : BN : BN :
Step 3
 Mixing Time  25 minutes
 Machine  50 Hz
Sieving and
Speed
Mixing
Step 4
Process
 Mixing Time  5 minutes
 Machine  50 z
Speed
Step 5
Slugging  Diameter  2 cm
and Sieving  Hardness  5-8 kg/cm2
Process Step 6
Mesh Size  Mesh 12
Step 7
 Machine  50 Hz
Speed
Mixing  Mixing Time  25 minutes
Process Step 8
 Machine  50 Hz
Speed
 Mixing Time  5 minutes
Step 9
Compressing
Caplet Weight 776-824 mg
Process
Setting
 Critical Acceptance Actual Actual Actual
Mfg. Stage Pass/Fail
Parameter Criteria BN : BN : BN :
Step 10
 Coater Speed  65 rpm
 Exhaust  1000-1500
Coating
Temperature rpm
Process
 Supply  10 minutes
Temperature
 Spray Rate  1-10 kW

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ATTACHMENT 6
PROCESS VALIDATION RESULT PROCESS

Manufacturing Acceptance Results Pass/

Operation Critical Parameter
Stage Criteria BN : BN : BN : Fail
Mixing Process Mixing Appearance Homogeneous
Color Brownish orange
Odor Specific
Assay of :
- Vitamin B1
95.0-150.0%
- Vitamin B2
- Vitamin B6
Assay of :
95.0-165.0%
- Vitamin E
Identification : Positive
- Curcuma longa
rhizome extract
- Silybin
phospholipids
- Schizandrae fructus
extract
- Choline L-Bitartrate
- Vitamin B1
- Vitamin B2
- Vitamin B6
- Vitamin B12
- Vitamin E
 Manufacturing Acceptance Results Pass/
Operation Critical Parameter
Stage Criteria BN : BN : BN : Fail
Moisture content Not more than 6 %
Compressing Compressing Appearance Homogeneous
Process
Form Caplet
Length 16.6 mm
Wide 8.6 mm
Thickness 6.3 ± 0.5 mm
PCI of thickness  1.33
Color Orange brown
Odor Specific
Sign Plain-plain
Weight of caplet 800 mg ± 3 %
PCI of weight  1.33
Not more than 2
caplets deviate from
Weight variation the average mass by
more than 5% and
none deviate by
more than 10%.
Hardness 5-8 kg/cm2
PCI of hardness  1.33
Friability Not more than 1.0 %
Disintegration time Not more than 30
minutes
 Manufacturing Acceptance Results Pass/
Operation Critical Parameter
Stage Criteria BN : BN : BN : Fail
Assay of :
- Vitamin B1 95.0-150.0%
- Vitamin B2
- Vitamin B6 95.0-150.0%
Compressing
Compressing Assay of :
Process 95.0-165.0%
- Vitamin E
Appearance Homogeneous
Form Film coated caplet
Thickness 6.7 ± 0.5 mm
Color Orange
Odor Odorless
Sign Plain-plain
Weight of caplet 840 mg ± 3 %
Not more than 30
Disintegration time
minutes
Water content Not more than 10%
Coating Process Coating Microbial enumeration
Total aerobic microbial Not more than
count 10,000 cfu/g
Total combined yeast and Not more than 1000
mold cfu/g
Absence of Eschericia Absence of
coli Eschericia coli in 10
g
Absence of salmonella Absence of
spp salmonella spp in
10 g
 Manufacturing Acceptance Results Pass/
Operation Critical Parameter
Stage Criteria BN : BN : BN : Fail

Heavy metal
Timbal (Pb) Not more than 10
ppm
Cadmium (Cd) Not more than 0.3
Coating Process Coating ppm
Arsen (As) Not more than 5
ppm
Mercury (Hg) Not more than 0.5
ppm
Stripping Process Stripping Leakage strip No leakage
Actual yield
product is
To be defined
Reconciliation counted and
( theoretical yield
compare with
32,298 caplets )
theoretical
yield
Note :

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