Lot 2-B-1, Phase 1B,

First Philippine Industrial Park,

JMS Healthcare PHL, Inc. Special Economic Zone,
Tanauan City, Batangas, Philippines

Document Code: INF-VPIQ-014-19

JMSH(P) IQ VALIDATION PROTOCOL

SEALING MACHINE No.4 FOR INFUSION SET LINE 4

Written By Checked By Approved By

Kristel Mae P. Balba
Production 1
Maintenance Engineer
Takuya Ono
QA/QC Deputy General
Manager/Management
Representative
Alvin F. De Mesa
Production 1
Maintenance Supervisor

Masaaki Shinkawa
Production Director

CONTENTS PAGE

INTRODUCTION / BACKGROUND 2
SCOPE 2
OBJECTIVE 2
VALIDATION PLAN / TEST PROCEDURE 2
VALIDATION TIMELINE 2
DESIGN QUALIFICATION 2
INSTALLATION CHECK 3
CRITERIA FOR REVALIDATION / VALIDATION 3
APPENDICES 4

M-00H005-002
 Lot 2-B-1, Phase 1B,
First Philippine Industrial Park,
JMS Healthcare PHL, Inc. Special Economic Zone,
Tanauan City, Batangas, Philippines

Document Code: INF-VPIQ-014-19

INTRODUCTION/BACKGROUND

This validation protocol consists of Installation Qualification (IQ) of Sealing Machine No.4.

The function of this Sealing Machine is to apply the final seal on Ribbon Pack (RP) Bag of Infusion Set.

Sealing Machine

This applies to Installation Qualification (IQ) of Sealing Machine No.4 of Infusion Set
SCOPE
Line 4.
To check the physical and ensure that the machine is functional after fabrication.
OBJECTIVE To verify and ensure that the parts from this new machine is good and suitable for
mass production.
V VALIDATION
A TIMELINE
L
I
D
A
T
I
O
N

P
L
A
N
/
T
E DESIGN
S QUALIFICATION
T

P
R
O
C

M-00H005-002
 Lot 2-B-1, Phase 1B,
First Philippine Industrial Park,
JMS Healthcare PHL, Inc. Special Economic Zone,
Tanauan City, Batangas, Philippines

Document Code: INF-VPIQ-014-19

E The purpose of this IQ is to demonstrate that the equipment specification is verified
D INSTALLATION and properly set up for Operational Qualification (OQ). This includes verification
U CHECK against items listed in INF-VPIQ-014-19-001 – “INSTALLATION QUALIFICATION
R CHECK LIST”.
E Takuya Ono
QUALITY PRODUCTION
QA/QC Deputy General
PERSON IN PERSON
Manager/Management
CHARGE IN CHARGE
Representative
CRITERIA FOR Re-validation shall be performed when there are major changes to material,
REVALIDATION / machine/equipment, methods, measurement and re-location.
VALIDATION Re-validation shall be performed when there are major failures, repairs or modification
to the machine/equipment.
Re-validation shall be performed when there are new material/parts being introduced
to the system/process.
APPENDIX INF-VPIQ-014-19-001 – INSTALLATION QUALIFICATION CHECK LIST

M-00H005-002