Revised Pharmaceutical Affair Law

and
Risk Management
Q9 Topic Leader of J PMA
Takayoshi Matsumura
Pharmaceutical Quality Forum
3rd Symposium
Customer Satisfaction
Define
Design
Manufacture
Change Control,
Annual Review
Technology
Transfer
Pharmaceutical
Development
Quality
Risk
Management
Customer Requirement
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Continuous Improvement
Validation of Process
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Industrialization study
Optimization study
Process Validation (PV)
Design Qualification
(DQ)
Installation Qualification
(IQ)
Operational Qualification
(OQ)
Performance Qualification
(PQ)
Development stage or historical data ( 12.11)
Process Validation Protocol
Actual production scale
Technology
Transfer
Pharmaceutical
Development
Quality (Management) System
Process
Validation
Cleaning
Validation
Support System
Validations
Computer
Validation
Method
Validation
Deviation
Re-Validation
Change Control
Corrective Action
Failure Investigation
Out of Specification
Validation
Annual Product Review
Low
Middle
High
Type of API
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Risk Classification
Risk Classification
Risk Classification
Example of Risk Management
Evaluation of API Supplier (1)

No. of deficiency
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High Priority
Middle Priority
Low Priority
Evaluation of API Supplier (2)
2004.11.22
Revised Pharmaceutical Affairs Law
and Current GMP
n Communication
n Deviation
n Change Control
n Internal Audits / Self-inspection
n Validation
Three Responsible Person
in Revised Pharmaceutical Affair Law
Manufacturer Branch and
Sales Offices
Contract
Receiver of
PMS
operations
Market Approval Holder
Manufacture Supervisor
Manufacturing
Unit
Quality
Unit
Responsible
Person
Responsible Person
Peron in
charge of DI
Final responsibility on
product for marketing
Marketing Supervisor - General
Head of Quality Unit Head of Safety Unit
Primary responsibility on QA operations
Peron in
charge of DI
Quality Management Organization
and Communication
Market Approval Holder
Manufacturer
Marketing Supervisor -
General
Head of Quality Unit
Manufacturing Unit Quality Unit
Manufacture Supervisor
Management
Manufacturing & Release Procedures
(Released by Quality Unit in Manufacturer)
Shipment
Manufacturer
Market Approval Holder
Market Supervisor - General
Head of Quality Unit
Quality Unit
Final Product
Intermediate
Product
Raw
Materials
IPC
Assignment of person in QU, and PMS information
Procedures for mfg. And Q. control and product release
Manufacturing and quality control results
Reports of
Deviation
and Change
Periodical Audit Result of
Product Release
Change Control System
Processing Step Raw materials Specification Support System
Change control committee
in Manufacturer
Change control committee
in Market Approval Holder
Change
Decision
Change control committee
in Manufacturer
Market Approval
Holder
Subjects
for Internal Audit / Self-inspection
Manufacturer
Market Approval Holder
Market Supervisor - General
Head of Quality Unit
Reporting Oversight
Quality Unit
Self-inspection
Self-inspection
Periodic Audit
(internal Audit)
Report of Corrective action