Discussion Forum on ICH-Q8 & Q10 at Getz Auditorium on 24 Sep 2017

1. Recap with
Simple & Clear Take Home Messages
Obaid Ali
Civil Service Officer / Deputy Director, DRAP
Member ISPE, PDA

2. Q10 is for your Benefit not a Scientific or Regulatory Burden
Robustness of Mfg Process
Continual Improvement
Risk / Variation

3. Q10 is for your Benefit not a Scientific or Regulatory Burden
Harmonized
Global
Language
Language
of Science

4. Q10 is for your Benefit not a Scientific or Regulatory Burden
Harmonized
Global
Language
Language of
Science
Consistency
Consistency

5. Q10 is for your Benefit not a Scientific or Regulatory Burden
System Processes Organization
Management
Responsibility
Promotes
Transparency

6. Q10 is for your Benefit not a Scientific or Regulatory Burden
Clarity in
understanding
applied
Quality System
Throughout the
Lifecycle

7. Q10 is for your Benefit not a Scientific or Regulatory Burden
Product
consistency
& availability
Product
failure
& complaints
GreaterAssurance
ReducedRisk
Better
Process
Performance

8. Q10 is for your Benefit not a Scientific or Regulatory Burden
Optimal use
of resources
Opportunity
Confidence
in product
quality
Enhanced
Industry Regulators
Increased
Understanding

9. Q10 is in place; Lets Demonstrate
Documentation Processes
Training/
Qualification
Management
Continual
Improvement
Performance
Key Performance Indicators

10. Q10 is in place; Lets Demonstrate by responding the questions
Is it simple for Management, Staff & Regulator to understand PQS
operation across the lifecycle?
For e.g. Quality Manual, Documentation, Flow Charts, Procedures
Is your system under surveillance through audit for
verification of system functioning at its best?

11. Be Strong; Keep knowledge managing & with you
Developmental
Information
• Design Space
• Chemometric Model
• Risk Management
At
Developmental
Site

12. Be Strong; Keep knowledge managing & with you
Basis of
Manufacturing Process & Control Strategy
Rationale of Selection for
Critical Process Parameters & Critical Quality Attributes
At Manufacturing Site

13. Understanding of
Product & Process
for Installation of
Appropriate Controls

14. DRAP strategy is aligned with the
DRAP is capable to implement
DRAP is sincere to implement
Be honest in
responding
Do you
think
Quality
Vision of
ICH

15. Manufacturer’s strategy is aligned with
Manufacturer is capable to implement
Manufacturer is sincere to implement
Be honest in
responding
Do you
think
Quality
Vision of
ICH

16. Hope you had a good day
Email: cultureofcultivatingknowledge@gmail.com
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Thank You