MultiMill IQOQPQ

VALIDATION PROTOCOL
FOR
MULTI MILL MACHINE
MODEL: CIMM-200
Purchase Order No.: HPP/181439 DATED 06-10-04
Cip Machineries Pvt. Ltd.

Registered Office :
10,11 Umiya Estate,
Nr.Bharat Party Plot, N.H.No.8,
Amraiwadi, Ahmedabad 380 026.
Gujarat, INDIA.
Phone: 91-79-287 54 10
91-79-289 25 30
91-79-297 04 06-7-8
TeleFax: 91-79-289 14 10
Works :
Plot No.1903, Phase IV,
Opp. Maradia Steel Unit-3,
G.I.D.C., Vatva,
Ahmedabad 380 026.
Gujarat, INDIA.
Phone: 91-79-583 59 08
91-79-583 53 41-2-3
TeleFax: 91-79-583 58 53
E-Mail : cipmachad1@sancharnet.in
sales@cipmach.com
Visit us on Internet at :
www.cipmach.com / www.roll-compactor.com
OUR VISION : TO ACHIEVE LEADERSHIP THROUGH QUALITY
Confidential
CIP MACHINERIES
PVT. LTD
VALIDATION PROTOCOL FOR MULTI

MILL MACHINE
PAGE 2 of 32
OBJECTIVE AND SCOPE:

It is the objective of this protocol to describe in detail the methodology to be adopted to qualify the
Multi Mill Machine GMP Model, intended to use in the manufacturing process. It is to establish
confidence that the Multi Mill Machine GMP Model is capable of consistently operating within
established limits and tolerance.
The protocol comprises of the following.
A) Installation Qualification:
It should describe the following:
1. Equipment Features
2. Pre Qualification
3. Statement of Purpose
4. Installation Checklist
5. Drawings
6. Materials of Construction
7. Major components verification
8. Supporting Utilities
9. Manufacturers recommendation for site acceptance test.
10. Supporting certificates and Drawings
11. Final Report
B) Operational Qualification:
It should cover the operating parameters set for the equipment operation. Validation of equipment
against these parameters should also be described.
It should also describe.
01. System description (Pre requisite of operation).
02. Sequential operational aspects.
03. Critical operational aspects.
04. Statement of purpose.
05. Operator training (user).
06. SOP development.
07. Deficiency (if any) and corrective action report.
Confidential
CIP MACHINERIES
PVT. LTD

MILL MACHINE
PAGE 3 of 32
08. Final report.
C) Performance Qualification:
It should cover the performance parameters set for the equipment performance. Validation of
equipment against these parameters should also be described.
It should also describe.
01. Equipment validation.
02. Performance qualification evaluation.
03. Final report.
D) Design Qualification:
01. Relevant drawings.
02. Final report.
E) Conclusion:
The Multi Mill Machine meets the acceptance criteria in reference to above parameters are declared
validated and released for use.
Confidential
CIP MACHINERIES
PVT. LTD

MILL MACHINE
PAGE 4 of 32
INSTALLATION QUALIFICATION
EQUIPMENT NAME
EQUIPMENT MANUFACTURER
EQUIPMENT LOCATION
: MULTI MILL MACHINE GMP MODEL.

: CIP MACHINERIES PVT. LTD.
:
TABLE OF CONTENTS
01.0 Equipment Features
02.0 Pre Qualification
03.0 Statement of Purpose
04.0 Installation Checklist
05.0 Drawings
06.0 Materials of Construction
07.0 Major Components Verification
08.0 Supporting Utilities
9.0
Manufacturers recommendation for site acceptance test.
10.0 Final Report
Confidential
CIP MACHINERIES
PVT. LTD

MILL MACHINE
PAGE 5 of 32
01.0 EQUIPMENT FEATURES
EQUIPMENT NAME
MODEL NO.
: CIMM-200
SERIAL NO.
: 295
DEPARTMENT
PURPOSE
: Milling of powder.
VALIDATION TEAM
NAME
DESIGNATION
SIGNATURE
DATE:
Q.A.
Manager
Production
Manager
Works
Manager
Maintenance
Manager
Confidential
CIP MACHINERIES
PVT. LTD

MILL MACHINE
PAGE 6 of 32
02.0 PRE QUALIFICATION
EQUIPMENT NAME
: Multi Mill Machine GMP Model
OUTPUT
: 50 to 200 kgs. per hour.(Depending on the material

Characteristic)
VENDOR SELECTED
: M/S Cip Machineries Pvt. Ltd.

Ahmedabad.
VENDER'S ADDRESS
: Plot No. 1903, G.I.D.C,

Phase IV, Opp. Maradia Steel Unit No. 3,
Nr. Neeka Tube Bus Stand,
Vatva, Ahmedabad.
Gujarat - 382 445.
MANUFACTURE'S NAME
: Plot No. 1903, G.I.D.C,

Phase IV, Opp. Maradia Steel Unit No. 3,
Nr. Neeka Tube Bus Stand,
Vatva, Ahmedabad.
Gujarat - 382 445.
TEAM INVOLVED IN SELECTION OF

EQUIPMENT
NAME
DESIGNATION
SIGNATURES
DATE
Project Incharge
Works Manager
Confidential
CIP MACHINERIES
PVT. LTD

MILL MACHINE
PAGE 7 of 32
02.1 PRE QUALIFICATION

EQUIPMENT QUALIFICATION
: Multi Mill Machine GMP Model
CERTIFICATION FROM VENDOR FOR
(A)
MATERIAL OF CONSTRUCTION
Contact parts SS 316 L
ACCEPTED FOR INSTALLATION

INSTALLATION TEAM
01.
02.
03.
04.
THE EQUIPMENT INSTALLATION IS CARRIED OUT AS PER GUIDELINES FRAMED BY

THE MANUFACTURER.
Confidential
CIP MACHINERIES
PVT. LTD

MILL MACHINE
PAGE 8 of 32
03.0 STATMENTS OF PURPOSE
The purpose of this protocol is to provide an outline for the inspection of equipment for
static attributes to verify that:
Each installed sub-component complies with the engineering design and equipment data
sheets / specifications.
The system is installed according to the design specifications and manufacturers

recommendations.
No unauthorized or unrecorded modifications have taken place.
Standard Operating Procedures have been identified and listed.
All supporting utilities are properly connected.
All safety features are accounted for.
All installation-testing reports are available and maintained on file.
Confidential
CIP MACHINERIES
PVT. LTD

MILL MACHINE
PAGE 9 of 32
05.0
INSTALLATION CHECKLIST
It shall be ensured that all civil, mechanical, electrical and instrumental requirement of the
equipment to be installed is fulfill. i.e. as bellow.
Consideration
No.
Statement
01.
Verify that the "As Built" drawings are complete and represent the design
concept.
Verify that major components are securely anchored and protected from
shock.
Verify that there is no observable physical damage
02.
03.
04.
05.
06.
07.
08.
09.
Yes/No
Verify that there is sufficient room for servicing provided

Verify that all piping and electrical connections have been done according
to the drawings.
Required electric connections are tight weather proof and grounded.
Equipment identification nameplate is visible.
Verify that all switches of starter of the machine are working satisfactory.
Proper earthing is made.
Comments: All the above-mentioned consideration is being checked and found satisfactory.
Reviewed & Inspected by: ______________________
Date :
Confidential
CIP MACHINERIES
PVT. LTD

MILL MACHINE
PAGE 10 of 32
06.0
DRAWINGS
Drawings are provided by the manufacturer and are complete.

Supporting relevant drawings / certificates prior to Installation of the equipment.
Sr. No.
01
Details
Ref. Drg.No.
Status
G.A drawing
Reviewed & Inspected by : ______________________
Date :
Confidential
CIP MACHINERIES
PVT. LTD

MILL MACHINE
PAGE 11 of 32
7.1 MAJOR COMPONENT VARIFICATION
Item
Hopper
Sieve
Beaters
Feed Hopper
Specification
CIP Make
CIP Make
CIP Make
CIP Make
Supporting
Certificates
SS 316 L
SS 316 L
SS 316 L
SS 316 L
Comments: Material of construction of equipment is as specified.
Review & Inspected by: _______________________Date:
Actual
Status
Confidential
CIP MACHINERIES
PVT. LTD

MILL MACHINE
PAGE 12 of 32
07.2 CONTACT PARTS MATERIALS OF CONSTRUCTION
Item Description
Hopper
Sieve
Beaters
Feed Hopper
Ref. certificate
As per attached herewith.
As above
As above
As above
Material of Construction
SS 316L
SS 316L
SS 316L
SS 316 L
Confidential
CIP MACHINERIES
PVT. LTD

MILL MACHINE
PAGE 13 of 32
7.3
MAJOR ELECTRICAL COMPONENTS

Item
Supporting Certificates
Motor
Starter
Status
Confidential
CIP MACHINERIES
PVT. LTD

MILL MACHINE
PAGE 14 of 32
08.0
SUPPORTING UTILITIES
List the supporting utilities and record whether or not they are properly connected and identified.
Utility
Properly Connected and

Identified (Yes/No)
Electrical connection
Water Connection
Air connection to clean the Machine
Comments: Utilities are properly attached.
Reviewed & Inspected by: ______________________
Date :
Checked by
Date
Confidential
CIP MACHINERIES
PVT. LTD

MILL MACHINE
PAGE 15 of 32
09.0
MANUFACTURERS RECOMMENDATION FOR SITE ACCEPTANCE TEST
Sr.No.
01
02
03
04
Description
Electrical Connection
Water Connection
Foundation
Compressed Air
connection
Specification
Four core cable to be connected to the machine
To clean the machine
Not applicable
Pressure 8 kg/cm2 for cleaning purpose.
Actual
Sign and Date:
Service Engineer
Plant Manager
Quality Engineer
Confidential
CIP MACHINERIES
PVT. LTD

MILL MACHINE
PAGE 16 of 32
10. SUPPORTING CERTIFICATES & DRAWINGS :
Sr. No.
1
2
3
Descriptions
RELEVENT DRAWINGS
MOC CERTIFICATES
BOUGHTOUT ITEMS CERTIFICATES
Actuals
Confidential
CIP MACHINERIES
PVT. LTD

MILL MACHINE
PAGE 17 of 32
11.0
FINAL REPORT
11.1
Summary:
The equipment shall be procured as per specification to M/s ALEMBIC LIMITED,
Installation is carried out as per manufacturers recommendations and user applicability.
supporting utilities will be connected.
11.2 Analysis / Evaluation:

The machine shall be installed at the location. Supporting utilities shall be connected and
Used for Functioning properly. Standard operating procedure shall be identified and listed.
History card shall be prepared for the equipment. All relevant critical document and
drawing shall be verified by the user.
Reviewed & Inspected by: ___________________
Date :
Confidential
CIP MACHINERIES
PVT. LTD

MILL MACHINE
OPERATIONAL QUALIFICATION
EQUIPMENT NAME
EQUIPMENT MAKE
EQUIPMENT LOCATION :
TAB LE O F C O N T E N T S
1.0
System Description (Pre requisite of operation)
2.0
Sequential Operational aspects.
3.0
Critical Operational aspects.
4.0
Statement of Purpose
5.0
Operator Training (User)
6.0
SOP Development
7.0
Deficiency (if any) and Corrective Action Report
8.0
Final Report
PAGE 18 of 32
Confidential
CIP MACHINERIES
PVT. LTD

MILL MACHINE
PAGE 19 of 32
01.0 SYSTEM DESCRIPTION
CIP MACHINERIES PVT LTD, Multi Mill Machine is a machine for milling of the powder with
output of 75-100 kg/hour. The unit consists of:
Base Plate
Support Pillar
Motor mounting
Hopper assembly
Sieve
Feed Hopper
The system has utilities like electrical connection and air connection connected to it.
Confidential
CIP MACHINERIES
PVT. LTD

MILL MACHINE
PAGE 20 of 32
01.1 SYSTEM DESCRIPTION
Item
Base Plate
Support Pillar
Motor mounting
Description
Hopper Assembly
The base plate is mounted on four wheels.

Drive assembly is mounted on the support pillar.
Motor is mounted on the motor mounting plate with the
help of four bolts.
Hopper assembly consists of Rotor assembly, Beaters etc.
Sieve
Sieve is mounted inside the hopper assembly.
Feed Hopper
Feed hopper is mounted on the upper portion of the

hopper.
Status
Confidential
CIP MACHINERIES
PVT. LTD

MILL MACHINE
PAGE 21 of 32
02.0 SEQUENTIAL OPERATION ASPECTS
Sr.No.
01
02
03
04
05
06
07
08
Operation / Activity
Cable from machine to main switch.
Specification
It should be four core three
phase.
Fix the plug as per the cable and It should be suitable to the
main switch.
three phase supply
Hopper assembly should be
dismantled to clean the
machine before use and should
be assembled as per the
instruction.
To start the machine.
Starter should be ON to start
the machine.
To stop the machine.
Starter should be OFF to stop
the machine.
Reverse / Forward Direction
Machine should be rotate in
Reverse / forward direction
depend upon the required
milling.
Pour the powder into the feed Powder quantity should be
hopper.
decided depending upon the
characteristic of the same.
Powder Collection after sieving
Powder should be collected
with the suitable drum,
collection bowl, polyethylene
bag etc. from the discharge
chute.
Actual
Confidential
CIP MACHINERIES
PVT. LTD

MILL MACHINE
PAGE 22 of 32
03.0 CRITICAL OPERATIONAL ASPECTS
Sr.No.
01
02
03
03
04
05
Operation / Activity
Specification
Hopper assembly should be
dismantled to clean the machine
before use and should be
assembled as per the instruction.
To start the machine.
Starter should be ON to start the
machine.
Reverse / Forward Direction
Machine should be rotate in
Reverse / forward direction
depend upon the required
milling.
To stop the machine.
Starter should be OFF to stop the
machine.
Pour the powder into the hopper Powder quantity should be
assembly.
decided depending upon the
characteristic of the same.
Powder Collection after sieving
Powder should be collected with
the suitable drum, collection
bowl, polyethylene bag etc. from
the discharge chute.
Actual
Confidential
CIP MACHINERIES
PVT. LTD

MILL MACHINE
PAGE 23 of 32
NAME OF EQUIPMENT: MULTI MILL MACHINE
04.0
STATEMENT OF PURPOSE
The purpose of this protocol is to validate the above equipment for the operational qualification to
1. Demonstrate that the equipment / system will perform reproductively and consistently within its
full dynamic range of operation according to manufacturers specifications.
2. Documents initial performance of the equipment / system.
3. Assure that the equipment / system performance is adequate to support the process for which the
system is designed.
4. Demonstrate the suitability of the SOP is established for the equipment / system.
Confidential
CIP MACHINERIES
PVT. LTD

MILL MACHINE
PAGE 24 of 32
06.0 SOP DEVELOPMENT
Subject
:
: Standard Operating procedure for the operation of
Multi Mill Machine.
Testing Date
Operating Personnel :
Observing Personnel :
Observation
Observation - Yes / No
(If no state why in comments)
Operating Personnel understand and follow SOP

description and requirements.
Most current revision in use
SOP provides adequate direction and control to
ensure uniform equipment operation.
Comments: Machine is operated as per Standard Operating Procedure.
Reviewed & Inspected by: _____________________
Date :
Confidential
CIP MACHINERIES
PVT. LTD

MILL MACHINE
PAGE 25 of 32
07.0
DEFICEINCY (IF ANY) AND CORRECTIVE ACTIONS REPORT:
Description of deficiency and date observed:
Person responsible for corrective action and date assigned:
Corrective actions taken and date conducted:
Conducted By:
Conducted By:
Date:
Date:
Comments (If any):
Verified By:
Name:
Signature:
Date:
Confidential
CIP MACHINERIES
PVT. LTD

MILL MACHINE
PAGE 26 of 32
08.0
FINAL REPORT
Summary
Analysis / Evaluation
Certification
The operation of the equipment MULTI MILL MACHINE GMP MODEL. was carried
out as per standard operating procedure.
The equipment performs within the assigned limits when operated as per approved
standard operating procedure.
Operating parameters that have a significant impact on the equipment ability to operate and
achieve the process are satisfactory and conforms to the acceptance criteria.
The equipment: MULTI MILL MACHINE - GMP MODEL.
Model No. CIMM-200
Location
Purpose
Equipment No.: 295
:
:
Use for sieving of the powder.
Frequency of Validation : Validation due on

or the event of any change in
critical component of the machine.
"THE EQUIPMENT "MULTI MILL MACHINE VALIDATED AND RELEASED FOR
USE.
DATE
Q.C. MANAGER
WORKS MANAGER
MAINTENANCE
MANAGER
Q.A. MANAGER
Confidential
CIP MACHINERIES
PVT. LTD

MILL MACHINE
PAGE 27 of 32
PERFORMANCE QUALIFICATION
EQUIPMENT NAME
EQUIPMENT MANUFACTURER
EQUIPMENT LOCATION
: MULTI MILL MACHINE - GMP MODEL.

:
TABLE OF CONTENTS
01. Equipment Validation.
02. Performance Qualification Evaluation.
03. Data Evaluation And Conclusion:
04. Final Report.
Confidential
CIP MACHINERIES
PVT. LTD

MILL MACHINE
PAGE 28 of 32
01.0
EQUIPMENT VALIDATION
The simulation of the process was carried out by sieving of the powder from the machine.
Simulation of the process consist of the following:
Sr.No.
Activity
01
Proper assembly of hopper.
02
Position of Sieve
03
Pouring of Powder
04
Powder collection
Functional Acceptance
Criteria
As per the details given with
the operating manual
It should be properly fixed
with the wings nut.
It should from the feed
hopper.
It should be from the
discharge chute.
Status / Observation
Confidential
CIP MACHINERIES
PVT. LTD

MILL MACHINE
PAGE 29 of 32
2.0
PERFORMANCE QUALIFICAION EVALUATION:
NAME OF MATERIAL:
PERFORMANCE CRITERIA - BEFORE MILLING:
1. APPERANCE:
2. SIEVE ANAYALSIS
PERFORMANCE CRITERIA - AFTER MILLING:
1
APPERANCE
SIEVE ANAYALSIS
Confidential
CIP MACHINERIES
PVT. LTD

MILL MACHINE
PAGE 30 of 32
03.0
DATA EVALUATION AND CONCLUSION:

Based on the quality control results generated by simulating the process and its review, it
can be said that machine performs satisfactory and conforming to the acceptance
criteria.
Reviewed by: _____________________Date :
Confidential
CIP MACHINERIES
PVT. LTD

MILL MACHINE
PAGE 31 of 32
04.0
FINAL REPORT
Summary
Analysis / Evaluation
Certification
The performance of the equipment MULTI MILL GMP MODEL. was carried out as
per
The equipment performs within the assigned limits when operated as per approved
Performance parameters that have a significant impact on the equipment ability to operate
and achieve the process are satisfactory and confirms to the acceptance criteria.
The equipment: MULTI MILL MACHINE - GMP MODEL.
Model No. CIMM200
Location
Purpose
Equipment No.: 295
:
:
Use for milling of the powder.
Frequency of Validation : Validation due on

or the event of any change in
critical component of the machine.
"THE EQUIPMENT "MULT MILL MACHINE VALIDATED AND RELEASED FOR
USE.
DATE
Q.C. MANAGER
WORKS MANAGER
MAINTENANCE
MANAGER
Q.A. MANAGER
Confidential
CIP MACHINERIES
PVT. LTD

MILL MACHINE
PAGE 32 of 32

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VALIDATION PROTOCOL

Cip Machineries Pvt. Ltd.

OUR VISION : TO ACHIEVE LEADERSHIP THROUGH QUALITY

VALIDATION PROTOCOL FOR MULTI

OBJECTIVE AND SCOPE:

VALIDATION PROTOCOL FOR MULTI

08. Final report.

VALIDATION PROTOCOL FOR MULTI

: MULTI MILL MACHINE GMP MODEL.

Manufacturers recommendation for site acceptance test.

10.0 Final Report

VALIDATION PROTOCOL FOR MULTI

: MULTI MILL MACHINE GMP MODEL.

VALIDATION PROTOCOL FOR MULTI

: Multi Mill Machine GMP Model

: 50 to 200 kgs. per hour.(Depending on the material

: M/S Cip Machineries Pvt. Ltd.

: Plot No. 1903, G.I.D.C,

: Plot No. 1903, G.I.D.C,

TEAM INVOLVED IN SELECTION OF

VALIDATION PROTOCOL FOR MULTI

02.1 PRE QUALIFICATION

: Multi Mill Machine GMP Model

CERTIFICATION FROM VENDOR FOR

Contact parts SS 316 L

ACCEPTED FOR INSTALLATION

THE EQUIPMENT INSTALLATION IS CARRIED OUT AS PER GUIDELINES FRAMED BY

VALIDATION PROTOCOL FOR MULTI

The system is installed according to the design specifications and manufacturers

No unauthorized or unrecorded modifications have taken place.

Standard Operating Procedures have been identified and listed.

All supporting utilities are properly connected.

All safety features are accounted for.

All installation-testing reports are available and maintained on file.

VALIDATION PROTOCOL FOR MULTI

Verify that there is sufficient room for servicing provided

Reviewed & Inspected by: ______________________

VALIDATION PROTOCOL FOR MULTI

Drawings are provided by the manufacturer and are complete.

Reviewed & Inspected by : ______________________

VALIDATION PROTOCOL FOR MULTI

Comments: Material of construction of equipment is as specified.

Review & Inspected by: _______________________Date:

VALIDATION PROTOCOL FOR MULTI

Comments: Material of construction of equipment is as specified.

Review & Inspected by: _______________________Date:

VALIDATION PROTOCOL FOR MULTI

MAJOR ELECTRICAL COMPONENTS

Comments: Material of construction of equipment is as specified.

Review & Inspected by: _______________________Date:

VALIDATION PROTOCOL FOR MULTI

Properly Connected and

Comments: Utilities are properly attached.

Reviewed & Inspected by: ______________________

VALIDATION PROTOCOL FOR MULTI

MANUFACTURERS RECOMMENDATION FOR SITE ACCEPTANCE TEST

Sign and Date:

VALIDATION PROTOCOL FOR MULTI

VALIDATION PROTOCOL FOR MULTI

11.2 Analysis / Evaluation:

Reviewed & Inspected by: ___________________

VALIDATION PROTOCOL FOR MULTI

System Description (Pre requisite of operation)