Soap Line No. - 3 - IQ-OQ

RECKITT BENCKISER (INDIA) LTD.
SITARGANJ
EQUIPMENT QUALIFICATION PROTOCOL
Protocol No.: UTT 1/EQP/Soap Line 03 003
Page 1 of 38
Equipment: Soap Line No. - 3

Revision :
Date: April. 2012
Soap Line No. - 3

Prepared by:
Signature
Date
Signature
Date
Signature
Date
QA Department
Reviewed by:
Production Executive
Approved by:
Manager Engineering
Production Manager
Quality Assurance manager
Site Head
DOCUMENT HISTORY
Revision
Date
Reason for Changing

SITARGANJ
Page 2 of 38

Revision :
Date: April. 2012
EQUIPMENT
Bottle Air Rinser
EQUIPMENT: QUALIFICATION
PROTOCOL
PROTOCOL NO. : Utt 1/EQP/Soap Line No. - 3 - 003
EQUIPMENT
: Soap Line No. - 3
LOCATION
: Soap Section, Unit - 1
DEPARTMENT
: Production

SITARGANJ
Page 3 of 38

Revision :
Date: April. 2012
OBJECTIVE :
To qualify the installation, operation, instrumentation, and

control system of the equipment. This qualification will also
define and document the evidence needed to verify that the
equipment is installed according to design specification and
complies with standard operating procedures and cGMP
requirements.
PROCEDURE :
Qualification to be carried out in the following sequential

order.
A. Installation qualification
B. Safety qualification
C. Operational qualification
D. Performance qualification & Conclusion

SITARGANJ
Page 4 of 38

Revision :
Date: April. 2012
INDEX
P A G E N O.
1.0
INSTALLATION
QUALIFICATION
5 - 15
2.0
SAFETY & ENVIRONMENTAL

QUALIFICATION
16 - 17
3.0
OPERATIONAL QUALIFICATION
18 - 19
4.0
PERFORMANCE QUALIFICATION
& CONCLUSION
20 40

SITARGANJ
Page 5 of 38

Revision :
Date: April. 2012
INSTALLATION QUALIFICATION
1.1 Objective
To Installed the soap line no. - 3 for

producing finish goods as per the specified
requirement.
1.3 Equipments P.O.

CAP/UTT1/SCE/11/03
CAP/UTT1/SCE/11/04
MIL India
Ltd.
Mazzoni
LB S.P.A.
DESIGN, MANUFACTURING &

SUPPLY OF TOILET SOAP
FINISHING LINE WITH METAL
DETECTOR (BEFORE CAKE
STAMPING) & FIRST FILLS OF OIL
FOR ALL EQUIPMENT:
CAPACITY :3 TON PER HOUR
DESIGN, MANUFACTURING,
SUPPLY, TESTING &
COMMISSIONING OF SOAP
STAMPING MACHINE ALONG WITH
OTHER ACCESSORIES.
(FOB NORTHERN ITALIAN PORT,
PACKED CONDITION)
CAP/UTT1/SCE/11/011
CAP/UTT1/SCE/11/074
CAP/UTT1/SCE/11/061
1.4 Supplier
1.5 Approved Installation

Drg
( Attach a copy of drg,
if any)
1.6 Procedure
Deep
electrical
Dhanvan
thri
Engineer
s Pvt.
Ltd.
Khosla
Machines
Pvt. Ltd.
Laying and fixing of Electrical

fittings
SOAP CONVEYING SYSTEM AS PER
DETAILS OUTLINED IN ANNEXURE2 ENCLOSED HEREWITH.
MIL INDIA
MAZZONI LB
DHANVANTHRI
KHOSLA
------
Toilet Soap wrapping Machine

[Model: WRAPPER - 4000T (3rd
Generation)] as per details

SITARGANJ
Page 6 of 38

Revision :
Date: April. 2012
1.6.1 Installation
Qualification
Checklist
1.6.2 Auxiliary
Equipment Features
1.6.3 List of Spare
Parts
1.6.4 Utility and
Services Required
1.6.5 Non-compliance
and thereafter
Compliance Reports
Details below..
1.6.1
INSTALLATION QUALIFICATION CHECK LIST
1.6.1.1
Equipment Details of Soap Line No. - 3

Equipment
Make
MODEL
YEAR
BATCH WEIGHING
SYSTEM
MIL INDIA
Double sigma mixture
MIL INDIA
simplex plodder
MIL INDIA
triple roll mill
MIL INDIA
HRM-3000
11-Nov
duplex plodder
MIL INDIA
B-350
11-Nov
metal detector
TECHNOFOUR
ELECTRONICS
PVT.LTD.
METALTRAP 03
SEP. 2011
DSM-SMIX-750
SEP. 2011
11-Oct

SITARGANJ
Page 7 of 38

Revision :
Date: April. 2012
stumper
MAZZONI LB
STUR-10/T16
2011
wrapping Machine
KHOSLA
W1- 874, W2874, W3-899,W4

-900
2011
TAPPING MACHINE
ITW
5 FAM
METLER TOLEDO
IND 560
auto weigh check

weigher
1.6.1.2
1.6.1.3
b.
Model / Make
: See in above table
c.
MFG.YEAR
: See in above table
e.
Capacity
f.
Location
: Soap Section, Production
g.
Purpose
: Soap Production
Operating manual Copy:

Available
Location
Purchase order (If available
: Yes
: FINANCE
Material in Product / Commodity contact (Parts Material)
Part
a)
3000 KGS/HRS
: Yes
: MAINT. OFFICER
Available
Location
1.6.1.4
2010
DSM
Specified
MS
Actual
MS
7
Remarks
OK

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Page 8 of 38

Revision :
Date: April. 2012
b)
c)
d)
SRP
TRM
DFP
MS
MS
MS
MS
MS
MS
1.6.1.5 Gear Box Oil:

DSM- SERVO MESH SP-220
SRP SERVO MESH SP-320
TRM SERVO SYSTEM -68, HYDRAULIC OIL GRADE -68
DFP - SERVO MESH SP-320
1.6.1.7 Motor & Gear Box Details:
DOUBLE SIGMA MIXER

MOTOR 1
Make
HP
RPM
:
:
:
NORD
30
19
:
:
:
NORD
40
26
:
:
:
NORD
75:69
PARALLEL GEARED MOTOR
MOTOR 2
Make
HP
RPM
MOTOR 1
Make
Ratio
Size & Type
OK
OK
OK

SITARGANJ
Page 9 of 38

Revision :
Date: April. 2012
MOTOR 2
Make
Ratio
Size & Type
:
:
:
NORD
57:43
PARALLEL GEARED MOTOR
Make
HP
RPM
:
:
:
ABB
40
1500
Make
Ratio
Size & Type
:
:
:
ABB
50:1
HELICAL GEAR BOX
Make
HP
RPM
:
:
:
ABB
45KW
1470
Make
Ratio
Size & Type
:
:
:
ABB
5:1
RI 140
Make
HP
RPM
:
:
:
ABB
50
1500
Make
Ratio
Size & Type
:
:
:
MIL INDIA
50:1
HELICAL GEAR BOX
SRP
TRM
DFP PRELIMINARY

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Page 10 of 38

Revision :
Date: April. 2012
DFP FINAL
Make
HP
RPM
:
:
:
ABB
60
1500
Make
Ratio
Size & Type
:
:
:
MIL INDIA
50:1
HELICAL GEAR BOX
Make
HP
MAZZONI LB
:
:
BONFIGLIOLI RIOOTTORI
.18 KW
Make
HP
RPM
:
:
:
AB (SERVO)
6.79 KW
3000
METAL DETECTOR
Dhanvanthri Conveyers: ALL MOTORS

Make
HP
RPM
:
:
:
SIEMENS
.37 KW
1380
WRAPPING M/C: ALL WRAPPING

Make
HP
RPM
:
:
:
SIEMENS
1.5KW
1400
10

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Page 11 of 38

Revision :
1.6.3
Date: April. 2012
LIST OF SPARE PARTS :

DSM
02. CO3
02. CO4
KEYLESS COUPLING
-2
PRECISION LOCK NUT
-2
02. CO7
OIL SEAL
-3
03. CO1
RINGFEDER LOCKING ELEMENT
-2
03. CO2
BEARING
-2
03. CO3
OIL SEAL
-3
03. CO4
LOCK NUT
-2
03. CO5
LOCK WASHER
-2
03. CO6
O-RING
-2
05. CO6
FRL UNIT FRC
-1
05. CO7
DOUBLE SOLENOID VALVE
05. CO8
SOLENOID VALVE COIL
-2
05. CO9
SILENCER
-2
-1
SRP
250-13-00
BALL BEARING FOR INPUT SHAFT
-1
250-14-00
TAPER ROLL BEARING FOR INPUT SHAFT
-2
250-15-00
Taper roll bearing for 1st intermediate shaft
-2
250-16-00
Taper roll bearing for 1st intermediate shaft
-2
11

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Revision :
Date: April. 2012
250-17-00
Spherical roller bearing for output shaft
-2
250-18-00
Oil seal for input shaft
-1
250-19-00
Oil seal for input shaft
-2
250-20-00
input pinion shaft
-1
250-21-00
input gear
-1
250-22-00
1st intermediate pinion shaft
-1
250-23-00
intermediate gear
-1
250-24-00
2nd intermediate pinion shaft
-1
250-25-00
output gear
-1
250-26-00
out put hollow shaft
-1
TRM
S. NO.
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
EQUIPMENT
PRECISION LOCK NUT
BEARING
TIMING BELT
ROTARY V-SEAL
O RING
BEARING
BEARING
NILOS RING
RADIAL SHAFT SEAL
ROTARY UNION-RH
ROTARY UNION- LH
CIRCLIP
NYLON CHEEK LH
NYLON CHEEK RH
SCRAPPER BLADE
12
PART NO.
01.C1
02.02C1
02.C4
03.01.C7
03.01.C8
03.02.C1
03.02.C2
03.02.C3
03.03.C7
03.07.C1
03.07.C2
03.07.C3
05.02.00
05.03.00
06.06.00

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16
17
18
19
20
21
22
23
24
Date: April. 2012

Page 13 of 38
SOLENOID VALVE
SOLENOID COIL
FRL UNIT
SILENCER
CONVEYOR BELT
BEARING
BUSH
RTD SENSOR
HYLUM FOR BELT SCRAPPER
06.C02
06.C03
06.C06
06.C07
07.00.C2
07.00.C1
09.05.03
07.07.01
SPARES FOR HYDRAULIC SYSTEM

1
2
3
4
5
6
SUCTION STRAINER
FILTER ELEMENT
SPARE SOLENOID COIL FOR DIRECTION VALVE
PRESSURE TRANSDUCER
SPARE DIAPHRAM FOR ACCUMULATOR
SEAL KIT FOR HYDRAULIC CYLINDER
DFP
S. NO.
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
EQUIPMENT
V BELT
V BELT
MAIN SGAFT
COUNTER SHAFT
OIL SEAL
BEARING
O RING
O RING
BEARING
OIL SEAL
OIL SEAL
U CUP OIL SEAL
O RING
O RING
BEARING
PART NO.
2.C4
2.C5
4.3
4.6
4.C1
4.C6
4.C7
4.C8
4.C9
4.C10
4.C12
4.C13
4.C16
4.C17
4.C21
13

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16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
1.6.4
Sr.
No.
a.
b.
f.
Date: April. 2012

Page 14 of 38
LOCK WASHER
LOCK NUT
LOCK WASHER
LOCK NUT
WORM RH
WORM LH
WORM SUPPORTING PIN
SPACER FOR WS PIN
BUSH FOR WS PLATE
SPACER FOR WS PLATE
EYE BOLT
NUT FOR EYE BOLT
WASHER
BUSH
SPACER
SHREDDER DRIVING SHAFT
SHREDDER (RH)
SHREDDER (LH)
O RING
O RING
O RING
4.C22
4.C23
4.C33
4.C34
7.1
7.2
9.1
9.3
9.4
9.5
9.8
9.9
9.1
9.18
9.19B
9.2
9.23B
9.24B
9.C4
10.2.C1
10.3.C1
UTILITIES AND SERVICES REQUIRED

Requirements
Compressed air
Electrical network
Steam
Specification
Verification
6 kg
As per drawing
NA
ok
ok
NA
(Verification to be authorized by the respective Manager)
14
Checked
by
Varun
Varun

SITARGANJ
Revision :
1.6.3
Date: April. 2012

Page 15 of 38
NON COMPLIANCE CONFORMANCE REPORT

Description of Non Compliance
- NA
Activities carried out to conform to the requirements ( Use
separate sheet, if required)
- NA
Result of rechecking
- NA
1.7 CONCLUSION : Since the IQ. Is satisfactory, the machine is qualified for
doing the operational qualification trials.
15

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Date: April. 2012

Page 16 of 38
SAFETY & ENVIROMENTAL QUALIFICATION

2.1
2.2
2.3
New Equipment Checklist

Machine Guarding Checklist
Management of Change
2.1 NEW EQUIPMENT CHECKLIST

1
2
3
Name of Equipment
Location of Equipment
Function of Equipment
4
5
Photograph of equipment
Short Description of modification,
in case of modification
Purpose of Modification
Have interlocks been interlocks on
1. All Guards are hinged and
are removable
2. Guards protect the point of
operation and doors to
hazardous transmission
drive
All interlocks drives in proper
working order on machine? Test
done to Verify?
Is Electrical wiring properly done
with proper electrical grounding? (
To be certified by Electrical
Manager)
Has an Electrical or Mechanical
lock-out capability been provided?
(Zero mechanical state)
Is the equipment safe in flammable
liquid process area?
6
7
8
9
10
11
DSM, TRM, Cutter, Stamper, Conveyor

Soap section Unit 1
Crushing, Refining, extruding, stamping cakes and
packing
NA
NA
Yes
Except the stumper M /c where the die fall when the power
supply goes off. Braking system is not functional
Earthing wire to be provided to inclined conveyor motors
Yes
Yes
16

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Revision :
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
Date: April. 2012
Is air line (if used) proper-specific

air pressure required for Operation
& Isolation capability?
If maintenance work is to be
carried out, can it be done with
Ease & Safely?
Is there enough room around the
machine for all free movement
whilst operating machine?
(Specific clear area measurement)
If a pressure vessel has pressure
test done & approved by
competent person?
Are all caution & special
instruction notices posted on
machine?
Are operating instruction
available?
Has a SOP been developed?
Have machine operators received
training
Has personal protective equipment
been identified obtained
& supplied?
Is operating height suitable so as
not to cause operational hazard?
Does the equipment have any fire
hazard?
If yes , is adequate precaution
taken ? (To be certified by Safety
Head)
Are there normal fire fighting
equipment provided?
Have all necessary material
handling problems been looked
Into & resolved?
Asbestos containing material used
in any part of the machine?

Page 17 of 38
Yes, Pressure vessel tested

Except the stumper machine
No, any work at height job, telescopic ladder cannot be
provided at the area
Pressure vessel test due on 27.06.2012
Yes
Yes
In Process.
Yes
Yes
Yes
No
Yes
Yes, fire extinguishers are placed near to the equipments
FG outer movement from the lollipop are to FG area is
difficult
No.
17

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Page 18 of 38

Revision :
Date: April. 2012
OPERATIONAL QUALIFICATIO
1
CHECK LIST FOR OPERATIONAL QUALIFICATION
3.1.1. SOP SOP to be made.

3.1.2. CALIBRATION - NA
1.4.3.
NO LOAD TRIAL & LOAD TRIAL

MACHINE
DSM1
CURRENT
amp
NO LOAD
18
LOAD
27
DSM2
amp
12
18
SRP
amp
21
39.2
TRM
amp
23
34
DFP1
amp
18.28
49.05
DFP2
amp
23.5
47.7
1.73
1.72
1.74
BELT CONVEYOR 2
1.75
1.74
1.74
LUBRICATION PUMP
1.01
1.02
HYDRAULIC PUMP
0.72
0.73
0.73
DISCHARGE CONVEYOR
0.74
0.74
0.73
VACUUM PUMP
2.49
2.48
2.49
BELT CONVEYOR 1
Parameters to be studied
OBSERVATIONS: ok
18

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Page 19 of 38
3.1.5 EQUIPMENT NON CONFORMANCE REPORT

Description of non- conformance
Sr. No.
Probable reasons for non

conformance
NA
Observation
NA
Correction of non- conformance

Sr. No.
Correction Done
NA
Done by
NA
Checked by
NA
Checked by
NA
REMARKS
NA
COMPLIANCE REPORT
Sr. No.
TRIAL TAKEN
NA
CONCLUSION :
Since the OQ. Is satisfactory, the machine is qualified for
doing the performance qualification trials.
19

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Date: April. 2012

Page 20 of 38
Performance Qualification
SUBJECT: Process Validation of Soap Manufacturing and packing process of Soap to be
manufactured using new Soap Line no 3 at Unit 1 Reckitt Benckiser India Limited,
Sitarganj.
PROTOCOL NUMBER
REVISION: 0
DATE: 19.04.12
SITE: Reckitt Benckiser India Limited , Unit 1
B 96 ELDECO , SIDCUL
Industrial Park , Sitarganj
EQUIPMENTS:
1. Sigma Mixer
2. Simplex Plodder
3. Triple Roll Mill
4. Duplex Plodder
5. Metal detector
6. Stamper
7. Wrapping Machines
8. Auto checkweigher Machine
9. IJP Outer coding Machine
OBJECTIVE:
To provide documented evidence that Soap when manufactured using Soap Line no 3 to meet the
desired quality standards.
Since the new soap line is being used for Manufacturing, Wrapping & packing, validation is required.
PREPARED BY:
Parveen Guleria / Girish Singh
Officer - QA
REVIEWED BY:
P. Ramudu
Manager - QA
SIGNATURE
Kuldip singh
Manager Production
T. Jayachandran
Manager - Maintenance
APPROVED BY:
20
DATE

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Date: April. 2012

Page 21 of 38
K.N. Jha
FM
Nitin Shetty
Head of QA South East Asia
Document History
Revision
Date
Reason of Changing
Original Issue
Table of Contents
Page No.
1.0 General Introduction
1.1 Background
1.2 Scope
1.3 Validation Team
3
3
3
2.0 Responsibilities
2.1 Technical Assurance
2.2 Site Manufacturing
2.3 Quality Assurance
3
3
3
3.0 Pre PQ Checklist
4
5
4.0 Performance Qualification (PQ) Trials

4.1 Lot Size
4.2 Equipment
4.3 Process Parameter Matrix
4.4 Critical Process Parameters
6
6
6
6
5.0 Acceptance Criteria
6.0 Failure Investigation
7.0 Conditional Acceptance
8.0 Disposition of Product
Attachment I Packaging Materials Confirmation Checklist
21

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Page 22 of 38
Attachment II Test Instrument Calibration Checklist
Attachment III- Sigma Mixer Data
Attachment IV Simplex Plodder Data
Attachment V Simplex Plodder, TRM and Metal detector Check list
Attachment VI Data Collection form
10-11
Attachment VII - Packing Operation
12-13
Attachment VIII - Chemical Analysis Report

1.0
GENERAL INTRODUCTION
1.1
1.2
1.3
Background:
In the View of Substantial Expansion Capacity, this Soap mfg & packing Line has been
commissioned in Unit 1
This Soap line no 3 will be used for Manufacturing, wrapping & packing of al variants &
SKUs of Soap.
Scope:
This is a prospective validation will involve Manufacturing, Wrapping and packing of 3
consecutive days of production to confirm the process consistency and reproducibility.
Validation Team:
RBIL QA
RBIL Production
RBIL Maintenance
2.0
14-15-16
: Girish Singh ,Parveen Guleria ,P Ramudu,

: Kuldip Singh ,Sanjay Tripathy
: T.Jayachandran, Varun, T Jeewahn, Dharampal
RESPONSIBILITY:
2.1
2.2
Technical Assurance
2.1.1
Approved Process, Product Specification
2.1.2
Approved RM/PM Specification.
2.1.3
Approved test methods
Site Manufacturing
22

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2.2.1

Page 23 of 38
Documentation of all process settings, conditions & adjustments during

validation in BMR
2.3
2.2.2
Staff/crew for process operation
2.2.3
Assist QA in completion of pre-PQ Checklist.
Quality Assurance:
2.3.1
PQ Protocol and approval prior to the process qualification runs
2.3.2
Testing and release of all raw materials.
2.3.3
Assist collection of the process qualification run samples and testing
2.3.4
Completion of validation run and report.
4.0 Pre-PQ checklist:

All relevant reference documents are listed below.
Check points
Product manufacturing license no. & issuance date.
Material Specifications
RM
PM
Process Specification
23
Number/Date
No change
Verified by
PG
No change in
formulation and
PMS
PG
No change in Batch
Manufacturing.
PG

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Date: April. 2012

Page 24 of 38
Check points
Product manufacturing license no. & issuance date.
Product Specification
Approved Art work copies
Approved Shade Cards (Light Standard Dark)
Approved Packaging Reference Materials
Product attributes & variables criteria
(Attachment IV)
Approved Standard Test Methods
Raw Materials
Packaging Materials
In-process Bulk
Finished Product
Testing Capability
Availability of Equipment & Accessories
Trained & Qualified Analyst
Released Materials
RM
PM
Instrument Calibration Records
Manufacturing
Stamping
Packing
Testing
Pre-Validation Equipment Cleaning & Sanitizing

Manufacturing
Process Validation Protocol
Number/Date
No change
Verified by
PG
No change in FG
specification
No change in AW of
Wrapper.
Existing shade
cards of Wrapper
are applicable
Same as existing
Existing AQL of
Soap are
applicable.
No change
PG
Available
PG
RM/PM Released
as per existing
protocols
Manufacturing ,
Stamping
Packaging,& testing
validation data is
attached
Packing
configuration is
same as existing.
PG
New Line
PG
PG
PG
PG
PG
PG
PG
PG
24

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Date: April. 2012

Page 25 of 38
PERFORMANCE QUALIFICATION (PQ) TRIALS:

Validation is demonstrated by establishing documented evidence from 5 validation batches,
which provide a high degree of assurance that a specific process will consistently produce a
product meeting its pre-determined specifications and quality attributes. Entire product
manufactured during the validation run must comply with the requirements set out in this
protocol.
5.1
Equipment:
Equipment
ID No.
Make
Sr. No.
MIL INDIA
PROJECT NO 455-02
TAG NO TSF- 2
MIL INDIA
PROJECT NO 455-04
TAG NO TSF- 3
MIL INDIA
PROJECT NO 455-07
TAG NO TSF- 5
MIL INDIA
PROJECT NO 455-10
TAG NO TSF- 7
DOUBLE SIGMA
MIXTURE
SIMPLEX PLODDER
TRIPLE ROLL MILL
DUPLEX PLODDER
METAL DETECTER
TECHNOFOUR
ELECTRONICS PVT.LTD.
STAMPER
MAZZONI LB
186/2011
WRAPPING MACHINE
KHOSLA
WTT/LIQ/FLG/LI
Z/WS-01
METLER TOLEDO
W1-875
W2-874
W3-899
W4-900
-
AUTO WEIGH
CHECKWEIGHER
Critical Process Parameters

Operation
5.2.1 Mfg : Soap Mixer
Critical steps & sampling

plan
Criteria for Acceptance
Observation
Collect samples from two

different places of sigma
mixer for each batch for 5
consecutive batches from the
TCC content and color in all

the 5 Batches checked must
be complying with FPS.
Annexure III
25

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Page 26 of 38
Double Sigma mixer for TCC

content & colour.
5.2.2 Simplex Plodder
Check the Cleaning and pore

size of Mess of Plodder on
shift basis for three days.
It should be neat and clean,

bulk should come out
smoothly.
Annexure IV
5.2.3 TRM
Check the feeding and

discharging roller mill gap in
every shift for 3 days.
Annexure V
5.2.4 Duplex Plodder
Check the Vaccum and

temperature of chiller.
Check the metal detector with
three standard once in every
shift for three days.
This must be :
Feeding Roller Gap :0.3mm
Discharging Roller Gap :
0.15mm
It should be approperiate
Metal detector functioning
should be ok
Annexure V
Should be complies with

RBIL Quality Standards
Annexure VI
Should be complies with

RBIL Quality Standards
Annexure VII
Should complies the

Standard
Annexure II
Should be accurate, proper

visible and readable.
Annexure VII
Criteria for Acceptance
Observation
5.2.5 Metal detector
5.2.6 Stamper
5.2.7 Wrapping
Machines
5.2.8 Auto
checkwiegher
5.2.9 IJP Outer coding
Check the soaps of Both dye

hourly basis for Weight, cake
finishing , Logo Apearance
etc.
Check the soaps of all
wrapping machines at hourly
basis for coding , wrapping
Quality.
Check the functioning,
calibration and tolerance of
machine shift basis for three
days.
Check outer coding on hourly
basis for three days.
Annexure
5.3 Critical FG Parameters

Parameters
Critical steps & sampling

plan
26

SITARGANJ
Revision :
Date: April. 2012

Page 27 of 38
5.3.1 Physical
Check every pallet as per

root +1 scheme for all FG KPI
parameters.
Should comply as per RBIL

AQL.
Annexure VII
5.3.2 Chemical
Collect the sample randomly

and check for all chemical
parameters on shift basis.
Should comply to Existing

Soap Analysis protocol.
Annexure VIII
6.0
ACCEPTANCE CRITERIA:
Validation will be deemed successful upon, product compliance for all Critical Product and
Process Parameters in accordance with the requirements set out in this protocol.
7.0
DEVIATION/FAILURE INVESTIGATION:
Any & all deviations with respect to meeting the requirements are to be investigated by the
validation team and documented as a failure investigation summary section in the validation
report. Failure investigation summary must include the following components
7.1
Description of the nature of the failure and its implications for product performance & consumer
acceptance.
7.2
Assessment of the cause of failure.
7.3
Corrective action plan.
7.4
Timeframe for completion of corrective action plan.
The failure investigation will remain open until the corrective action is complete. At the
completion of corrective actions, a failure investigation closure report will be written and
approved.
8.0
CONDITIONAL ACCEPTANCE:
The validation may be accepted by the validation committee, if one or more of the acceptance criteria
are not met, with the following conditions
27

SITARGANJ
Revision :
Date: April. 2012

Page 28 of 38
8.1
The justification for conditional acceptance shall be documented in the PQ report
8.2
Consideration of potential impact on product function and consumer acceptance.
8.3
Review of potential causes and corrective actions.
Corrective action plan shall be defined and shall come with designees and a schedule. Outputs of the
conditional acceptance are documented in a Validation Report, reviewed and approved by validation
committee.
9.0
DISPOSITION OF PRODUCT:
All products produced during PQ runs will be held, until completion of the validation program.
Following successful completion of the validation program products produced during PQ and
meeting requirements can be considered for release.
ANNEXURE I
Packaging Materials Confirmation Checklist
Packaging Material
Stiffener
Wrapper
Outer
Self Adhesive BOPP Tape
TDS No.
A.R. No.
0267111
D0267101
D0271408
PU12D/1459
PU12B/919
PU12D/1669
PU12D/0794
ANNEXURE II
Test Instrument Calibration Records
28
Verified by /
Date
19.04.12/GS
19.04.12/GS
19.04.12/GS
19.04.12/GS

SITARGANJ
Revision :
Date: April. 2012
Instrument
Instrument
Identification
Production
Balance
Capacity : 6kg

Page 29 of 38
Last
Calibration
Date
Next
Calibration
Date
Verified by /
Date
GS
RU/WB/SOAP/09
Auto checkweigher
Calibration
18/04/12
18/07/12
WTT/LIQ/FLG/LIZ/WS09/09/11
01
08/09/12
GS
ANNEXURE III
Sigma Mixer Data
Parameter
Batch No.1
Batch No.2
Batch No.3
Batch No.4
Batch No.5
TCC content
Color
Checked By
0.66 & 0.67
OK
Firoz
0.66 & 0.68
OK
Firoz
PG/ GS
OK
Firoz
PG/ GS
0.67 & 0.66
OK
Firoz
PG/ GS
0.67 & 0.68
OK
Firoz
PG/ GS
Checked By
Verified by
0.68 & 0.68
Verified by
PG/ GS
ANNEXURE IV
Simplex Plodder Data
Parameter
19.04.12 G Shift
20.04.12 G Shift
21.04.12 G Shift
Cleaning
OK
Mess pore size

OK
OK
OK
OK
OK
29
Pankaj
Pankaj
Firoz
PG
PG
PG

SITARGANJ
Revision :
ANNEXURE V
Simplex Plodder, TRM and Metal detector Check list
Parameter
19.04.12 G Shift
20.04.12 G Shift
21.04.12 G Shift
Cleaning
of SP
Mess pore
size of SP
Gap of
feeding
roller
Gap of
Discharging
roller
Functioning
of Metal
Detector
OK
OK
OK
OK
Clean
Verified
by
PG
Clean
OK
OK
OK
OK
PG
Clean
OK
OK
OK
OK
PG
Annexure VI
Data Collection Form
Fill weight check: Recommended Tablet Weight
70gm :
68.6 gm to 71.4gm (Average weight should not be less than 70gm
120gm :
Soap - 70g Weight - Line NO. 3 at Unit - 1
ate : 19/04/12
ange in gm 70g 2%
Cavity
No./ Time
9:45
Date: April. 2012

Page 30 of 38
Shift - General
( 68.6 to 71.4 )
Upper Dye
Cavity 1
70.83
Cavity 2 Cavity 3
70.16
70.96
Cavity
4
71.11
Lower Dye
Cavity
5
70.99
Cavity
6
70.90
30
Cavity
1
70.77
Cavity Cavity
2
3
70.83 71.33
Cavity
4
71.1
Cavity 5
71.02
Cavity
6
71.09

SITARGANJ
Revision :
10:40
11:30
12:40
1:40
2:30
3:40
4:40
5:40
Average
aximum
Minimum
Date: April. 2012
70.24
71.06
70.13
71.11
71.1
71.31
70.36
71.25
71.29
71.04
71.36
70.67
71.22
71.01
70.34
71
71.36
70.24
71.41
70.97
71.27
70.95
70.68
71
71.41
70.13
71.37
71.03
71.09
71.26
70.91
71
71.37
70.91
71.15
70.76
71.53
71.21
70.97
71
71.53
70.36
71.44
70.86
71.05
70.94
70.76
71
71.44
70.76
Shift - General
( 68.6 to 71.4 )
70.16
70.96
70.13
71.1
71.11
70.36
71.99
71.29
ate : 20/04/12
ange in gm 70g 2%
9:45
70.83
10:40
70.24
11:30
12:40
71.06
71.11
71.31
71.25
71.09
1:40
14:45
15:55
17:15
17:50
19:00
20:00
20:45
21:45
Average
aximum
Minimum
71.36
71.17
70.93
70.33
70.27
71.41
71.22
70.83
70.2
70.36
71.34
71.12
71.1
70.25
70.64
71.15
70.5
70.4
70.27
70.35
71.44
71.27
71.15
70.39
70.74
70.37
70.4
71
71.36
70.24
71.05
70.47
71
71.41
70.13
71.4
71.1
71
71.4
70.25
70.68
70.44
71
71.25
70.27
70.27
70.76
71
71.99
70.27

Page 31 of 38
71.28
Bypass
STOP
Bypass
Bypass
Bypass
Bypass
Bypass
71
71.28
70.9
71.11
71.17
71.27
71.32
71.64
71.16
71.23
71.25
70.09
71.42
71.23
71.12
71.17
71.22
71.63
71.54
71.06
71
71.63
70.77
71.31
71.01
70.95
71.63
70.54
71
71.63
70.54
71.37
70.99
70.91
71.09
71.12
71
71.64
70.91
71.27
71.17
70.95
71.05
71.06
71
71.27
70.95
71.29
71.18
71.24
70.97
71.08
71
71.42
70.09
71.39
71.11
71.26
70.99
71.08
71
71.39
70.99
70.90
71.28
By
Pass
Stop
By
Pass
71.3
71.25
70.33
70.22
Stop
Stop
70.64
70.65
71
71.3
70.22
70.77
71.11
70.88
71.27
71.33
71.64
71.1
71.23
9:45
10:40
70.83
70.24
71.17
71.32
71.16
71.25
11:30
71.06
71.17
70.17
71.05
70.33
70.34
71.31
71.12
71.08
70.36
70.25
71.37
70.8
70.6
70.29
70.36
71.27
71.12
70.8
70.37
70.64
1:40
14:45
15:55
17:15
17:50
71.36
71.17
70.93
70.33
70.27
70.32
70.68
71
71.17
70.17
70.65
70.35
71
71.32
70.25
70.7
70.27
71
71.64
70.27
70.25
70.34
71
71.27
70.25
20:45
21:45
Average
Maximum
Minimum
70.37
70.4
71
71.36
70.24
Soap - 70g Weight - Line NO. 3 at Unit - 1

31

SITARGANJ
Page 32 of 38

Revision :
Date: April. 2012
Date :21/04/12
Range in gm
Shift - A+B
70g
2%
( 68.6 to 71.4 )
Upper Dye
Cavity No./ Time Cavity 1
7:10
70.51
8:15
9:20
70.52
10:32
11:30
69.97
12:35
70.1
1:45
70.16
2:50
69.92
3:50
70.16
5:10
69.78
6:15
70.17
7:10
70.16
8:00
70.12
9:00
10:00
Average
70
Maximum
70.52
Minimum
69.78
Lower Dye
Cavity
2
70.48
Cavity
3
70.76
Cavity
4
70.5
Cavity
5
70.4
70.6
70.49
70.4
70.62
70.1
70.25
70.19
69.68
70.22
70.32
70.19
70.06
70
70.08
69.96
70.03
69.78
69.9
69.96
70.16
70
69.92
70.16
70.19
69.91
70.16
69.92
69.97
69.96
70.1
69.84
69.97
70.12
69.96
69.8
69.94
70.1
69.94
69.92
69.99
70
70.6
69.68
70
70.76
69.78
70
70.5
69.84
70
70.62
69.8
Cavity Cavity Cavity Cavity Cavity Cavity Cavit

6
1
2
3
4
5
6
70.71
70.2 70.62 70.81 70.54 70.59 70.7
STOP
70.81 70.76 70.21 70.41 70.61 70.29 70.6
STOP
70.3
69.98 69.91 70.08 69.72 70.1 69.9
69.96
69.9 69.91 70.14 70.06
70
69.9
69.94 70.16 69.96 70.22 70.1
69.9
69.9
70.13 69.72 69.92 69.72 70.01 70.03 69.8
70.2
70.16 70.19 69.9 69.92 69.83 69.7
69.81 69.68 69.85 69.88 70.1 69.68 70.0
69.61 69.95 70.06 70.22 69.9
70.1 70.1
70.01 70.03 69.96 69.99 69.99 69.86 70.2
70.1
70.02 69.92 69.91 70.04 70.05 70.1
STOP
STOP
70
70
70
70
70
70
70
70.81 70.76 70.62 70.81 70.61 70.59 70.7
69.61 69.68 69.85 69.72 69.72 69.68 69.7
Annexure VII
DATA COLLECTION FORM
32

SITARGANJ
Page 33 of 38

Revision :
Date: April. 2012
DATE: 19.04.12, SHIFT G

Packing Operation
Parameter LOGO
Wrapping
Quality
9:45
10:40
11:30
12:40
1:40
2:30
3:40
4:40
5:40
Coding on
Wrapper
Coding on
Outer
Outer
Taping
Quality
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
Check
weigher
Performan
ce
OK
OK
OK
OK
OK
OK
OK
OK
OK
Verified by
PG
PG
PG
PG
PG
PG
PG
PG
PG

Packing Operation
Parameter
LOGO
9:45
10:40
11:30
12:40
1:40
14:45
15:55
17:15
17:50
Wrapping
Quality
Coding on
Wrapper
Coding on
Outer
Outer Taping
Quality
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
Verified
by /
Date
PG
PG
OK
OK
OK
OK
OK
PG
OK
OK
OK
OK
OK
PG
OK
OK
OK
OK
OK
PG
OK
OK
OK
OK
OK
PG
OK
OK
OK
OK
OK
PG
OK
OK
OK
OK
OK
PG
OK
OK
OK
OK
OK
PG

Packing Operation
33

SITARGANJ
Page 34 of 38

Revision :
Parameter
7:10
8:15
9:15
10:30
11:30
12:30
13:30
14:50
15:50
17:10
18:15
19:10
20:00
21:00
10:00
Date: April. 2012

LOGO
Wrapping
Quality
Coding on
Wrapper
Coding on
Outer
OK
OK
Outer
Taping
Quality
OK
OK
Verified
by /
Date
GS
GS
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
GS
OK
OK
OK
OK
OK
GS
OK
OK
OK
OK
OK
GS
OK
OK
OK
OK
OK
GS
OK
OK
OK
OK
OK
OK
GS
OK
OK
OK
OK
GS
OK
OK
OK
OK
OK
GS
OK
OK
OK
OK
OK
GS
OK
OK
OK
OK
OK
GS
OK
OK
OK
OK
OK
GS
OK
OK
OK
OK
OK
OK
GS
OK
OK
OK
OK
GS
OK
OK
OK
OK
OK
GS
Annexure VIII
Chemical Analysis Report (Reference: FPS: 104197, Issue No. 02, Date: 01 April 12.)
Date: 19.04.12, Shift:
G
34

SITARGANJ
Revision :
Date: April. 2012

Page 35 of 38
Parameter
Specification
Findings
Verified by
Appearance
Essentially free from abrasion marks, pitting, sharp

surface marking and surface dirt. Color should be uniform
with no patchy appearance
Strong orange colored soap cake, comparable with
Standard Shade Range
As per approved art work from RBIL, QA.
Characteristic pineceous and phenolic odour, Comparable
to standard.
The word "Dettol (R)" with a sword logo is embossed on
one face. Letter size for the word "Dettol" and regd. trade
mark (R) and size of sword logo should be as per the
approved art work.
When packed should be within +/- 2 % of the filled weight
claimed.
14 % w/w maximum.
71% w/w minimum
0.8% w/w maximum
Complies
PG
Complies
PG
Complies
PG
Complies
PG
Not less than 250 ml.
309.83
0.05% w/w maximum.
0.035
0.665% - 0.77%, w/w.
0.693
10 ppm maximum.
0.47-0.58% w/w.
6.45 g/50 cm2 maximum
0.565
5.73
Should be grade 7 or better

Appearance, colour and odour should be comparable to
the standard.
4
4
Coulor
Shape of cake
Odour
Surface marking
Tablet weight
Loss on drying
Total Fatty Matter
Chloride as Nacl
Lather (5 % Aq.
Soln.)
Free caustic alkali
as NaoH
TCC Content
Chloroaniline
content
Total Phenolic
Mush
Bar feel Wash
down
Dry Crack Test
Wet Crack Test
Accelerated aging
test
Rosin acid % by
Mass of TFM
Matter insoluble
in alcohol
Free Carbonated
PG
Complies
70.16
13.18
71.35
0.523
Complies
3 % w/w maximum.
10 % w/w maximum.
7.19
1 % w/w maximum.
35
PG
PG
PG
PG
PG
PG
PG
PG
PG
PG
PG
PG
PG
PG
PG
PG
PG

SITARGANJ
Revision :
Date: April. 2012

Page 36 of 38
alkali
Annexure VIII
Chemical Analysis Report (Reference: FPS: 104197, Issue No. 02, Date: 01April, 2012
G
Parameter
Specification
Findings
Verified by
Appearance

surface marking and surface dirt. Color should be
uniform with no patchy appearance
Complies
GS
Complies
GS
Shape of cake
Complies
GS
Odour
Characteristic pineceous and phenolic odour,

Comparable to standard.
one face. Letter size for the word "Dettol" and regd.
trade mark (R) and size of sword logo should be as per
the approved art work.
claimed.
14 % w/w maximum.
71% w/w minimum
0.8% w/w maximum
Complies
GS
309.83
0.05% w/w maximum.
0.044
0.665% - 0.77%, w/w.
0.691
10 ppm maximum.
0.47-0.58% w/w.
0.565
5.55

Appearance, colour and odour should be comparable to
the standard.
4
4
Coulor
Surface marking
Tablet weight
Loss on drying
Total Fatty Matter
Chloride as Nacl
Lather (5 % Aq.
Soln.)
Free caustic alkali
as NaoH
TCC Content
Chloroaniline
content
Total Phenolic
Mush
Bar feel Wash
down
Dry Crack Test
Wet Crack Test
Accelerated aging
test
36
GS
Complies
70.24
13.15
71.77
0.525
Complies
GS
GS
GS
GS
GS
GS
GS
GS
GS
GS
GS
GS
GS
GS

SITARGANJ
Page 37 of 38

Revision :
Rosin acid % by
Mass of TFM
Matter insoluble
in alcohol
Free Carbonated
alkali
Date: April. 2012
3 % w/w maximum.
10 % w/w maximum.
7.05
1 % w/w maximum.
GS
GS
GS
Annexure VIII
Chemical Analysis Report (Reference: FPS: 104197, Issue No. 02, Date: 01April, 2012
G
Parameter
Specification
Findings Verified by /
Date
Complies
Appearance
PG
surface marking and surface dirt. Color should be uniform
with no patchy appearance
Complies
PG
Color
Complies
PG
Shape of cake
Odour
Surface marking
Tablet weight
Loss on drying
Total Fatty Matter
Chloride as Nacl
Lather (5 % Aq.
Soln.)
Free caustic alkali
as NaOH
TCC Content
Chloroaniline
content
Total Phenolic
Characteristic pineceous and phenolic odour,

Comparable to standard.
one face. Letter size for the word "Dettol" and regd.
trade mark (R) and size of sword logo should be as per
the approved art work.
claimed.
14 % w/w maximum.
71% w/w minimum
0.8% w/w maximum
Complies
303.79
0.05% w/w maximum.
0.034
0.665% - 0.77%, w/w.
0.691
10 ppm maximum.
0.47-0.58% w/w.
0.538
37
PG
PG
Complies
70.19
13.09
71.72
0.524
PG
PG
PG
PG
PG
PG
PG
PG
PG

SITARGANJ
Revision :
Date: April. 2012

Page 38 of 38
PG
Mush
Bar feel Wash
down
Dry Crack Test
5.94
PG
Wet Crack Test
PG
Accelerated aging
test
Rosin acid % by
Mass of TFM
Matter insoluble
in alcohol
Free Carbonated
alkali
Appearance, color and odour should be comparable to

the standard.
Complies
3 % w/w maximum.
10 % w/w maximum.
7.46
1 % w/w maximum.
38
PG
PG
PG
PG
PG

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RECKITT BENCKISER (INDIA) LTD.

Equipment: Soap Line No. - 3

Date: April. 2012

Soap Line No. - 3

Reason for Changing

RECKITT BENCKISER (INDIA) LTD.

Equipment: Soap Line No. - 3

Date: April. 2012

PROTOCOL NO. : Utt 1/EQP/Soap Line No. - 3 - 003

: Soap Line No. - 3

: Soap Section, Unit - 1

RECKITT BENCKISER (INDIA) LTD.

Equipment: Soap Line No. - 3

Date: April. 2012

To qualify the installation, operation, instrumentation, and

Qualification to be carried out in the following sequential

RECKITT BENCKISER (INDIA) LTD.

Equipment: Soap Line No. - 3

Date: April. 2012

SAFETY & ENVIRONMENTAL

RECKITT BENCKISER (INDIA) LTD.

Equipment: Soap Line No. - 3

Date: April. 2012

To Installed the soap line no. - 3 for

1.3 Equipments P.O.

DESIGN, MANUFACTURING &

1.5 Approved Installation

Laying and fixing of Electrical

Toilet Soap wrapping Machine

RECKITT BENCKISER (INDIA) LTD.

Equipment: Soap Line No. - 3

Date: April. 2012

INSTALLATION QUALIFICATION CHECK LIST

Equipment Details of Soap Line No. - 3

Double sigma mixture

triple roll mill

RECKITT BENCKISER (INDIA) LTD.

Equipment: Soap Line No. - 3

Date: April. 2012

W1- 874, W2874, W3-899,W4

auto weigh check

: See in above table

: See in above table

: Soap Section, Production

Operating manual Copy:

Material in Product / Commodity contact (Parts Material)

RECKITT BENCKISER (INDIA) LTD.

Equipment: Soap Line No. - 3

Date: April. 2012

1.6.1.5 Gear Box Oil:

DOUBLE SIGMA MIXER

RECKITT BENCKISER (INDIA) LTD.

Equipment: Soap Line No. - 3

Date: April. 2012

RECKITT BENCKISER (INDIA) LTD.

Equipment: Soap Line No. - 3

Date: April. 2012

Dhanvanthri Conveyers: ALL MOTORS

WRAPPING M/C: ALL WRAPPING