Welcome to Fukuoka BC

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h234m
Fukuoka
h84m
F212m
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Plasma fractionation center
Chitose
Inventory hold Specimen storage
Hokkaido Island
Center for NAT Quarantine
77,983km2
Honshu Island
820km
22,7961km2
Fukuchiyama
NAT center
Fukuoka
Tokyo
900km
36,737km2
Kyushu Island
4,000 islands 378,000km2 3,000km
Shikoku Island
860km
18,298km2
Okinawa Island
1,207km2
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200mL 1,615 400mL
46,455 Apheresis 15,268 total 63,338
Fukuoka-Kitakyushu RC BC
237 medical facilities
1.7M
4,844km2
Fukuoka RC BC
Centralized Plant
409 medical facilities
3.3M
200mL 3,562 400mL
84,983 Apheresis 47,037 total 135,582
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JICA training for NBTS Sri Lanka (Blood Bank
Development Project)
Objectives of the program a. To provide a basic
understanding on the system of the blood
transfusion services in Japan b. To provide a
general overview and awareness of the
principles, techniques and standards of the blood
banking practices as applicable to the
training center. c. To provide an opportunity
to acquire knowledge and hands on skills in
specific areas of the blood bank activities. d.
e.
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GMP in Japan
Ministerial Ordinance on Standards for
Manufacturing Control and Quality Control for
Drugs and Quasi-drugs
GMP was fully amended on December 24th, 2004 in
accordance with the provisions of Article
14,Paragraph 2, Item 4 of the Pharmaceutical
Affairs Law that specifies that such standards
shall be provided by the Ministry of Health,
Labor and Welfare Ministerial Ordinances. .
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Content of Ministerial Ordinances
Chapter 1 General Provisions (Article 1 to
3) Chapter 2 Manufacturing Control and Quality
Control at the
Manufacturing Plants of Drug Manufactures, etc.
Section 1 General Rules (Article 4 to 20)
Section 2 Manufacturing Control and Quality
Control of Drug Substances
(Article 21 to 22) Section 3 Manufacturing
Control and Quality Control of
sterile Drugs (Article 23 to 25) Section 4
Manufacturing Control and Quality Control of
Drugs of Biological-origin
(Article 26 to 30) Section 5 Miscellaneous
Provisions (Article 31) Chapter 3 Manufacturing
Control and Quality Control at the
Manufacturing Plants of Quasi-drug
Manufacturers, etc. (Article
32) Supplementary Provisions
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Chapter 2 Manufacturing Control and Quality
Control at the Manufacturing Plants of
Drug Manufactures, etc. Section 1 General
Rules (Article 4 to 20) A4. Processing
Department and Product Quality
Department A5. Product Security Pharmacist A6.
Employees A7. Product Master Formula A8.
Procedure Manual, etc. A9. Buildings and
Facilities A10. Manufacturing Control A11.
Quality Control A12. Management of releasing
product from manufacturing plant
Continued
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Chapter 2 Manufacturing Control and Quality
Control at the Manufacturing
Plants of Drug Manufactures,
etc. A13. Validation A14. Management of
amendments A15. Management of deviations A16.
Handling information about the quality of the
product and measures against quality
defects, etc. A17. Recall actions A18.
Self-inspections A19. Education and Training
A20. Management of document and records
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A3The licensed marketing approval holders of the
drugs shall have the manufacturer, etc.
conduct the manufacturing control and
quality control of the products in the
manufacturing plant.

Manufacturer, etc.
A4
Plant
Product Security Pharmacist (Doctor)
A5
Product Quality Department Responsible person
in charge of quality control
Processing Department Responsible person in
charge of manufacturing control
A4
A6
etc
etc
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Chapter 2 Manufacturing Control and Quality
Control at the Manufacturing Plants of
Drug Manufactures, etc. Section 1 General
Rules (Article 4 to 20) A7. Product Master
Formula A8. Procedure Manual, etc.
Continued
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Documents
Manufacturing control standard code
Products Master Formula
Hygienic control standard code
Old Standard Operation Procedure
Standard Operation Procedure
Operation Procedure
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Records of Manufacturing
41years
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Chapter 2 Manufacturing Control and Quality
Control at the Manufacturing Plants of
Drug Manufactures, etc. Section 1 General
Rules (Article 4 to 20) A9. Buildings and
Facilities A10. Manufacturing Control
Continued
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Dressing facility for changing shoes and clothes
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Entrance of Operation Room
No entry of non staff
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The person who is not a preparation staff
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How to change shoes
Take of the shoes
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How to change shoes
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Take another shoes
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How to wash
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Mirror
Sample
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2006.11.2 2006.12.1
Open day Expiry day
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Samples
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Opening strict prohibited
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Pass box
Entrance for aseptic room
Aseptic room
out
in
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Damper for differential pressure
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Sample
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Changing time of ultraviolet rays lamp
How to enter and go out
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Air shower
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Pass box-in
Differential pressure meter
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Pass box-out
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Inside of aseptic room
Clean bench
100 particles/f3
10,000 particles/f3
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Maintenance of equipments
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Central alarm system 1
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Central alarm system 2
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Temperature Record Form
Person 1
Person 2
Person 3
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Date of maintenance2005/11/25 Date of next time
2006/11
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Date of changing record paper
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Date of maintenance2005/12/14 Date of next time
2006/12
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After the repair, approval of section head is
needed before use of equipment.
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Report on annual maintenance of aseptic room
Cleaning and sterilization,
Environmental monitoring
in 2006
Sani-clean Corporation
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Cleaning and sterilization
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Bacteria test on the surface
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Checking performance of filter
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X control chart of cell counter
_
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Cleaning freezer
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??
Cleaning freezer
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Cleaning record form
person
Place
Good
Bad
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??????(???)
Bad
Good
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Validation plan for year
Same as education/training
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Validation of freezer
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Validation data
Product Security Doctor
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Incident report form
Incident monthly report
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Materials control
Materials room 1
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Insert
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Insert for FFP
Certificate by Quality Control Section
Not for use yet
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Source blood
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Attention
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Acceptance source blood
Weekly schedule for receiving blood
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Checking weight
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Shortage of volume
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Input lot number by bar code reader
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Program No
Integrated G
6
person
1
2
4
3
5
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MAP soln
Plasma
Buffy coat
Red cell
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MAP
Plasma
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Appearance test
Approval by section head
Standard for ?????
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Appearance test
Standard for hemolysis
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Appearance test
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Input of lot number
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X ray irradiation process
How to put into
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Number of products in the tray
8 unit
MAP
10 unit
Platelet
X ray indicator
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X ray label note
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Integrated gray
Time to exchange X ray lamp
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Integrated gray
Color change
Integrated time
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Draw oblique line
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One way
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Refrigerator
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Checking test result
Positive blood
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Write with red pen
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Discarded as Infectious disposable and burned
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Label printer
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Thank you for your listening!
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