Change Control

Pharmaceutical Quality Forum 3rd Symposium

Revised Pharmaceutical Affair Law and Risk Management

Q9 Topic Leader of JPMA

Takayoshi Matsumura

Continuous Improvement   n   o    i    t   a    i   r   a    V    /    t   n   e   m   e    l   p   p   u    S

Customer Requirement

Define Change Control,  Annual Review

Quality Risk  Management

Manufacture Technology Transfer Customer Satisfaction

Pharmaceutical Development

Design

  n   o    i   s   s    i   m    b   u    S   y   r   o    t   a    l   u   g   e    R

Validation of Process M  a n  u f    a  c   t    u r  i   n  g f    a  c  i   l   i    t   i    e  s  M  a n  u f    a  c   t    u r  i   n  g  p r   o  c   e  s   s   e  s 

Design Qualification (DQ) Installation Qualification

(IQ) Operational Qualification

(OQ) Performance Qualification

(PQ)

Pharmaceutical Development

Development stage or historical data (§ 12.11)

Technology Transfer Process Validation (PV)

Optimization study

Industrialization study

Process Validation Protocol Actual production scale

Quality (Management) System Validation Process Validation

Cleaning Validation

Support System

Validations

Computer Validation

Deviation

Method Validation

Out of Specification

Failure Investigation

Corrective Action

Re-Validation

Change Control

Annual Product Review

Exa xam mple of of Risk Manag Management Evaluation of API Supplier (1) Type of API

  n   o    i    t   a   u    l   a   v    E   s   u   o    i   v   e   r    P

   l   a    i   e   p   o   c   a   m   r   a    h   p

High Middle Low

  c    i    t   n  p   o  e   n  s   a

  c    i    t   p   e   s   a

Risk Classification Classification Ⅰ

Risk Classification Classification Ⅱ

Risk Classification Classification Ⅲ

Evaluation of API Supplier (2) No. of deficiency   y   n   a   m

  n   o    i    t   a   c    i    f    i   s   s   a    l    C    k   s    i    R

  e    l    d    d    i   m

  w   e    f

High Priority Middle Priority

Ⅰ Ⅱ Ⅲ

Low Priority

Revised Pharmaceutical Affairs Law and Current GMP n

Communication n

Deviation

n

Change Control

n

Internal Audits Audits / Self-inspection Self -inspection

n

Validation

Three Responsible Person in Revised Pharmaceutical Affair Law Market Approval Holder  Marketing Marketing Supervisor Supervisor - General Final responsibility on product for marketing

Head of Quality Unit

Head of Safety Unit

Primary responsibility on QA operations

Manufacturer

Branch and Sales Offices

Manufacture Supervisor 

Manufacturing Unit

Quality Unit

Responsible Person

Peron in charge of DI

Peron in charge of DI

Responsible Person

Contract Receiver of PMS operations

Quality Management Organization and Communication Market Approval Holder  Marketing Supervisor General

Management

Head of Quality Unit

Manufacturer  Manufacture Supervisor 

Quality Unit

Manufacturing Unit

Manufacturing & Release Procedures (Released by Quality Unit in Manufacturer) Market Approval Holder  Market Supervis Supervisor or - General

Head of Quality Unit ⑤ Periodical Audit

④ Result of 

① Assignment of person in QU, and PMS information

Product Release

Procedures for mfg. And Q. control and product release

③ Reports of 

Manufacturer 

Deviation and Change

Quality Unit ② Manufacturing and quality control results

Shipment

Final Product

Intermediate Product

IPC

Raw Materials

Change Control System Processing Step

Raw materials

Change control committee in Manufacturer 

Specification

Support System

Change control committee in Manufacturer 

Change control committee in Market Approval Holder 

Decision Market Approval Holder 

Change

Subjects for Internal Audit / Self-inspection Market Approval Holder  Market Supervisor Supervisor - General

Oversight

Reporting

Head of Quality Unit Self-inspection Periodic Audit (internal Audit)

Manufacturer  Report of Corrective action

Quality Unit Self-inspection