QUALIFICATION REPORT
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Address:
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INSTALLATION AND OPERATIONAL QUALIFICATION –
Facility:
Estimate complete date:
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Prepared by ……………………………………..…… ……………….
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Agreed by ……………………………………..…… ……………….
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Reviewed by ……………………………………..…… ……………….
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Approved by ……………………………………..…… ……………….
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Authorized by ……………………………………..…… ……………….
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PART A. Filling And Capping Machine (IQ&OQ)
PART B. Labeling Machine (IQ&OQ)
PART C. Cartoning Machine (IQ&OQ)
PART D. Cellophane Wrapping Machine (IQ&OQ)
PART E. Overall Summary of Cannabis Oil Packing System
FINAL REPORT
Conclusion Results
Qualification Report Review Reference Page
(Pass/Fail)
IQ Report has been reviewed. Pass/ Fail
OQ Report has been reviewed. Pass/ Fail
Overall Conclusion:
All IQ/OQ acceptance criteria are met.
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Pass / Fail
Recommendation: For general GMP, validation status maintenance, calibration, requalification,
risk potentials awareness, and safety requirements.
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PART A.
INSTALLATION
QUALIFICATION
TABLE OF CONTENTS
FINAL REPORT 2
I. INTRODUCTION 5
II. PURPOSE 5
III. SCOPE 5
IV. RESPONSIBILITY 6
V. INSTALLATION QUALIFICATION (IQ) 6
1. Machine Description 6
2. Machine Identification 7
3. Utilities 8
4. Major Components 9
5. Safety Features 10
6. Documents Required to Support IQ Requirements 10
7. Installation Qualification (IQ) Deviation Report 11
8. Installation Qualification (IQ) Report 12
VI. OPERATIONAL QUALIFICATION (OQ) 13
1. General Modes of Function in Both Cleaning Units 13
2. Quality Mode of Function in Cleaning for glass bottle 60 ml. 14
3. Cleanliness Test Results 14
4. Safety Mode of Function in Both Cleaning Units 15
5. Documents Required to Support OQ Requirements 16
6. Operational Qualification (OQ) Deviation Report 17
7. Operational Qualification (OQ) Report 18
VII. REPORT ACCEPTANCE CRITERIA 19
VIII. REFERENCES 19
IX. APPENDIX 19
X. ATTACHMENTS 19
DOC No. :
I. INTRODUCTION
Background
1. According to PIC/S [1&2] and WHO [3] Guidelines, qualification of equipment
including installation qualification (IQ) and operational qualification (OQ) is required to
confirm its installation per manufacturer’s specifications and intended functionality as initially
designed.
2. The Cannabis Oil Packing System Machine is manufactured by Data-Pak, And The
Machine is planned to install by A Grateful Rich Co., Ltd. in Government Pharmaceutical
Organization Facility (GPO) Patumthani Branch . in July 2021 and requires such a
qualification.
Rationale
3. The IQ/OQ study will be carried out to confirm the machine’s conformance to installation
and operational requirements.
IQ requirements include identification of the basic machine and auxiliary unit’s major
components (generating impact on product quality and safety to product, personnel, or
environment as appropriate) and supporting utilities as well as calibration reports of key
instruments and identification of manufacturer’s Operation & Maintenance (O & M) Manuals
and major change/spare parts.
OQ requirement includes verification of all key modes of function (having an impact on quality
and safety as appropriate). The scope of IQ/OQ studies can be summarized as below.
II. PURPOSE
1. To verify that the machine is installed in compliance with GMP regulations,
manufacturer’s specification, and The GPO engineering & safety standards (IQ objective).
2. To identify the key instruments which need to be calibrated and ensure that the
calibration reports are in place.
3. To identify the major components and supporting utilities as well as the manufacturer’s
Operation & Maintenance (O&M) Manuals and major change/spare parts (IQ objective).
4. To verify that the machine does operate as designed in all key modes of function (OQ
objective).
III. SCOPE
The scope of this qualification report is applied to Installation, and Operational Qualification
Cannabis Oil Packing System Machine is manufactured by Data-Pak, And The Machine is
planned to install by A Grateful Rich Co., Ltd. in Government Pharmaceutical Organization
Facility (GPO) Patumthani Branch
Checked by A Grateful Rich Review by GPO Approved by GPO
Name: Name: Name:
Date: Date: Date:
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