current situation and updates of qms inspection in …current situation and updates of qms...
Post on 06-Mar-2020
5 Views
Preview:
TRANSCRIPT
Current Situation and Updates of QMS
Inspection in Japan
Office of GMP/QMS InspectionPharmaceuticals and
Medical Devices Agency
1
Framework of Approval Review and QMS Inspection on Medical Device
2
Application Form
ApprovalApplication
Form
Review Divisions 軽微変更届出
Design transfer to manufacturing site
Approval
Minor ChangeNotification
1) Acceptance2) Confirmation
at regularinspection
QMS inspectionbefore approval
Partial ChangeApplication
1) Review2) QMS inspection
Actual production
QMS inspection every 5 years after approval
Pre-approval Post-approval
Product realization,Measurement,Analysis of data,Improvement
Types of QMS Inspection
3
Compliance inspection
1 Pre-approval inspection 2 Post-approval inspection
(periodic inspection)
For-cause inspection
Authority of GMP/QMS Inspection
4
Site Location Domestic Foreign
IVDs
・New drugs・Radioactive drugs PMDA PMDA
Products without CS* Prefectures PMDA
Products with CS* Registeredcertification body
Registeredcertification body
Medical Devices
・New medical devices・Cell / Tissue-based
medical devices・Class Ⅳ products
PMDA PMDA
Class Ⅲ and Class Ⅱproducts (without CS*) Prefectures PMDAClass Ⅱ products(with CS*)
Registeredcertification body
Registeredcertification body
*CS : Certification Standards
Compliance Inspection by PMDA
5
* New medical devices are, as a rule, limited to ones that have new principle or new functional characteristics.
Target Products Target Sites1. New medical devices*2. Cell-tissue-based
medical devices3. Class IV medical devices4. Radioactive IVDs
1. Manufacturing Sites2. Sterilization Facilities3. Storage Facilities4. Testing Laboratories5. Design and
development institutes
On-site Inspection and Document Review
6
Complexity of manufacturing processes
Risk associated with the use of products
Results of the previous on-site inspections
Previous nonconformity, recall, or the contents
On-Site Inspection Document Review
Principle of QMS On-site Inspection and Document Review (Concrete Example)
7
Facility A
1st application of QMS inspection (Product “a”) 2nd application
(Product “b”)3rd application(Product “c”)
4th application(Product “d”)
On-site inspection
On-site inspectionDocument
review ※Document review ※
2 years* (time after the 1st notification of QMS compliance result)※ Document review is confined to the facility not having
experienced Class-1 recalls and field corrections.Major manufacturer concerned with the product for marketing
approval application ※※
※※ Major manufacturer of the product : Facility A is supposed.
Manufacturing sites concerned with the product for marketing approval application(Example)
Assembling
Contract Sterilization
Packaging, Labeling or Storage
Packaging, Labeling or Storage(domestic)
Facility A
Facility A’ (backup of Facility A)
Facility B
Facility C
Facility D
On-site inspection
On-site inspection
Document review
Document review
Document review
a: PTCA Catheter b: Pacemaker c: Stent d: Defibrillator
Relation between MHLW MinisterialOrdinance #169 and ISO13485:2003
8
MHLWOffice Memorandum
May 30, 2011
Q & A regarding the relation between Ministerial Ordinance #169 and ISO13485:2003
9
Relation between MHLW MinisterialOrdinance #169 and ISO13485:2003
MHLW Ministerial
Ordinance #169ISO13485:2003
Additional Requirements
(almost) Equal Requirements
10
Contents of MHLW Ministerial Ordinance #169(QMS Ordinance)
Chapter 1 General Provisions
Chapter 2 Medical Devices
Manufacturers, etc.Chapter 4
Biological-origin Medical Device, etc. Manufacturers,
etc.
Chapter 3 Labeling, etc. – Category
Medical Devices Manufacturers, etc.
*Chapter 5 : In-Vitro Diagnostics Reagents Manufacturers, etc.(The provisions of Chapter 2 and 3 shall be applied Mutatis Mutandis.)
11
Relation between MHLW MinisterialOrdinance #169 and ISO13485:2003
Min
iste
rial
Ord
inan
ce #
169
Req
uire
men
ts
ISO13485:2003Requirements
#169
Cha
pter
2 R
equi
rem
ents
Additional Requirements
#169 Chapter 3Requirements
#169Chapter 4
Requirements
12
Additional Requirements
Retention period of obsolete controlled documents and records
Written procedure of training
Additional Requirements regarding infrastructure
#169
Cha
pter
2A
dditi
onal
Req
uire
men
ts
13
Check!! MHLW Ministerial Ordinance #169
http://www.pmda.go.jp/english/service/ministerial.html
Available PDF File:Ministerial Ordinance #169
More information about details of PMDA’s QMS Inspection
14
http://www.pmda.go.jp/english/service/qms.html
15
Thank you very muchfor your kind attention!!
top related