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Summary Caldece 112.8 KG New
Summary Caldece 112.8 KG New
Prepared by:
Function Name/Title Signature Date
Novita Purwanti /
Production
Process Validation Coordinator
Frisky Almuksiti /
Validation
Process Validation Engineer
SUMMARY
SANMOL FORTE Tablet is one of toll manufactured product from PT. Sanbe Farma to PT.
Caprifarmindo Laboratories. Process validation of SANMOL FORTE Tablet batch number
OK8501 has been performed on October 28th, 2013 according to the process validation protocol
document number VAL-PV/PVP/MB/068 dated September 09th, 2013. The objective of this
validation is to ensure that the production process of SANMOL FORTE Tablet based on the batch
record for 120 kg batch size will produce high degree quality product consistently. The validation
covers mixing, granulating, compressing and stripping process of SANMOL FORTE Tablet.
The critical parameters in mixing and granulating process are mixer speed, mixing time, mass
appearence, identity, moisture content and assay.
During granulating process, adding water and mixing time over than from the written in the batch
record. This is because the massa have been yet to perfect wet. Statement noted in the batch
record.
The result of sampling on mixing and granulating process, could be seen at table below :
Loss on Drying
Sampling Point Loss on Drying (%) Acceptance Criteria Pass/Fail
A1 1.9 Pass
A2 1.9 Pass
A3 1.5 Pass
A4 1.6 Pass
T1 1.8 Pass
≤ 3.0 %
T2 1.6 Pass
T3 1.5 Pass
T4 1.5 Pass
B1 1.4 Pass
B2 1.4 Pass
Assay of Acetaminophen
Sampling Assay Average Standard RSD
Pass/Fail
Point (97.0 – 105.0 %) (%) Deviation (≤ 5%)
Top (A) 97.9 99.8 2.1 2.1 Pass
Top (B) 102.4
The critical parameters and testing points in compressing step are machine speed, compression
force, tablet weight, identity, uniformity of dosage units, hardness, thickness, friability,
disintegration time and related subtance comply with acceptance criteria.
Assay of Acetaminophen
Sampling Assay Average Standard RSD Pass
Point (97.0 – 105.0 %) (%) Deviation (≤ 5%) /Fail
Beginning 98.1
Middle 98.5 98.1 0.4 0.4 Pass
End 97.8
Related Subtances
Acceptance Criteria Result Pass/Fail
peak area 4-aminofenol sample ≤ peak area
MS Pass
4-aminofenol 3rd solution (0.1%)
peak area 4-cloroasetanilida sample ≤ peak
MS Pass
area 4-cloroasetanilida 4th solution (10 bpj)
nothing peak area contamination over than
MS Pass
main peak area 2nd solution (0.25%)
Acceptance
Sampling Point Assay (%) Average (%) Pass/Fail
Criteria
Beginning 95.6 Pass
> 85% (Q+5) in 45
Middle 91.7 94.5 Pass
minutes
End 96.3 Pass
The critical parameters and testing points in stripping step are temperature roller and leakage test.
All critical parameters comply with specification and no one leakage on stripping process.
All critical point and testing result comply with the acceptance criteria. Based on the described
data above, process validation of SANMOL FORTE Tablet batch number OK8501 has passed the
test parameter of finished product. Therefore the result of this validation is PASS.
RECOMMENDATION
The batch record can be implemented for routine production.
TABLE OF CONTENTS
SUMMARY.......................................................................................................................................2
1. OBJECTIVE................................................................................................................................8
2. SCOPE.........................................................................................................................................8
3. VALIDATION TEAM..................................................................................................................8
3.1. Team Member.....................................................................................................................8
3.2. Responsibilities...................................................................................................................8
3.2.1. Production Department.........................................................................................8
3.2.2. QC Department.....................................................................................................9
3.2.3. QA Department.....................................................................................................9
3.2.4. Validation Department..........................................................................................9
3.2.5. R&D Department..................................................................................................9
3.2.6. Engineering Department.....................................................................................10
3.2.7. PPIC Department................................................................................................10
4. PROCESS VALIDATION STAGE............................................................................................10
4.1. Responsible Personnel......................................................................................................10
4.2. Starting Material................................................................................................................10
4.2.1.Formula.....................................................................................................................10
4.2.2.Specification & Test Procedure Number of Raw Materials......................................10
4.2.3. Specification & Test Procedure Number of Packaging Materials............................11
4.2.4. Specification & Test Procedure Number Finished Product.....................................11
4.2.5. Machines/ Equipments.............................................................................................11
4.3. Room Condition................................................................................................................12
4.4. Process Schematic Flow....................................................................................................13
4.5. Production Process, Critical Parameter, Testing Point and Analysis Method...................14
4.6. Sampling Plan...................................................................................................................17
4.6.1. Sampling in FBD Jaw Chuang............................................................................17
4.6.2. Sampling in BOHLE...........................................................................................18
5.6.1. Sampling During Tablet Pressing.......................................................................18
5.6.2. Sampling during Stripping..................................................................................19
4.7. Acceptance Criteria...........................................................................................................20
5. CONCLUSION OF THE PROCESS VALIDATION................................................................20
The result of comparison between the actual yield and theoretical yield of SANMOL FORTE
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 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.
3. VALIDATION TEAM
3.1. Team Member
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
\\Cimareme\Release\Capri\Val\VAL-PV\Report\MB\068-B2 – Sanmol Forte Tablet Process Validation Report- R00.doc
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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
Responsible for:
1. Reviewing and approving validation protocol and report for SANMOL
FORTE Tablet.
2. Ensuring that cleaning validation activities conform with quality assurance
requirements.
Personnel who are responsible for each step of production process is attached in
attachment 1.
PL = Polycellonium
PT = Plain Transparant
4.5. Production Process, Critical Parameter, Testing Point and Analysis Method
Croscarmellose
Sodium (3.600 kg) Sieving (2E) Granulator Screen 2 mm
Talc (1.200 kg) Jaw Chuang
OG
Silicon Dioxide
Colloidal (2.400 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
A
TOP
D
B
C
MIDDLE
E
H
BOTTOM F
G
I
TOP
MIDDLE B
A
D
C BOTTOM
E F
5.
Picture 2. Sampling Point in BOHLE
The result of comparison between the actual yield and theoretical yield of SANMOL FORTE
Tablet batch number OK8501 is 98.3 %.
All critical point and testing result comply with the acceptance criteria. Based on the
described data above, process validation of SANMOL FORTE Tablet batch number OK8501
has passed the test parameter of finished product. Therefore the result of this validation is
PASS.
6. DISCUSSION
N/A
7. RECOMMENDATION
The batch record can be implemented for routine production.
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
\\Cimareme\Release\Capri\Val\VAL-PV\Report\MB\068-B2 – Sanmol Forte Tablet Process Validation Report- R00.doc
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DEVIATION REPORT
( ) ( ) ( )
Revision
Date Description Originator
No.
00 02 July 2014 Initial Release Frisky Almuksiti