Professional Documents
Culture Documents
(Compressed) True Sense
(Compressed) True Sense
Test 3. Test1
(Visual Inspection) Test 10. Test4
(Electric resistance measurement ) (Visual Inspection)
Mfg.
Mfg. ISO Class 7 GHI
ABC Assembly 4. Assembly 2
(Welding process) Storage
(Coating)
Cleaning 5. Cleaning
Test 11. Test 5
6. Test 2 (Visual Inspection)
Test
(Visual Inspection)
(Leakage current measure) Mfg. Packaging / Labeling 12. Outer containers
JKL
Cleaning / Packaging /
7. Cleaning/Packaging/Labeling 13.Final Inspection
Labeling Final Inspection
(Cleaning) (Visual Inspection)
(Sterilized packaging process)
Test 8. Test 3 Decision on whether the
(Visual Inspection) products an be shipped
(Bio burden testing) Registration
0
Example
Sample2 Mutual relations of QMS
Marketing Authorization
Holder(JKL, Ltd.) Agreement QMS(ABC, Co.)
実地調査
MNO, Co.(Registration)
Design facility
GHI Distribution Center
(Inspection・Storage)
ABC Mfg. site
STU, Mfg. site.
(Registration)
Assembling plant
Main assembling plant
Agreement
JKL Distribution Center
QMS(DEF, Co.) :Same QMS
(Registration)
(Distribution Center)
DEF, Mfg. site(Registration)
(Sterilizer) :Information
exchange
1
Example
Form2 Outline of MAH/RMS (1/2)
Outline of manufacturing site As of DD/MM/YY
Product utilizing
medicine/cellular and
tissue-based product
Specified biological product
Changes history of mfg. site Changes of product / mfg. process (if important)
(please select items, and specify Changes of QMS organization
details.) Changes of top management or management representative
Others ( )
No Change
Details
Not applied article 4 and article 83 of QMS ordinance (MHLW Ministerial Ordinance No.169 in 2004)
History of QMS inspections by regulatory authorities and registered certification body over the past 5 years.
Name regulatory Inspection date The products subject to Inspection results Type of Inspection
authorities/registered the inspection (On-site or Desk-top)
certification body
3
Example
Form3 Products list for application
No. Product Generic Trade Approval classification Date of Expiry * Mfg. site
family name name (certification) approval date registration
No. (Certification)
* If sterilizer or distribution center are different, write these mfg. site’s name.
4
Example
Sample3 Layout of RMS
Aerial photograph
Site boundary of or location map of
RMS RMS.
S Building
Distinguish a
Q Building building affecting a
subject of product.
T Building
R Building
5
Example
Sample4 Floor plan of RMS(1/2)
ISO Class 7
a passage way differential
pressure
Manufacturing Manufacturing (>10Pa)
Sterilizer
Shipping
Warehouse Sterilization
Sterilizer 1 Sterilizer 2
6
Example
Sample4 Floor plan of RMS(2/2)
KIKOU JIRO
Human Quality & Regulatory Affairs Finance Global
Resource Reconstruction operation
Management Representative
Regulatory Mfg QA
Affairs department department
department
Mfg. site A QC
department
9
Example
Sample7 Seihin Hyojyun Syo
Requirements Reference documents(name, number, etc) Location
(sites)
10
Sample8 Example
Soldering 1/1/2014 1/2/2014 1/3/2014 ABC Repairing Soldering Soldering iron D-01,
iron D-01, D-02 D-02
Packing N/A 1/2/2014 1/3/2014 ABC Change setting value Heat Sealer P-01
(Temp:105℃→110℃)
11