Presented at Karachi in a Tofflon Seminar to Professionals of Pharmaceutical Manufacturing Industry

1. Pakistan’s Pharmaceutical
Scientific & Regulatory Practices
Obaid Ali, R. Ph., Ph. D
Civil Services Officer
Member ISPE & PDA
12 April 2017

2. D
I
S
C
L
A
I
M
E
R
Not the view
of DRAP
Current
judgment
No
obligation
on DRAP
Regulatory
experience
This presentation discusses science and has nothing to do with
any commercial Product.

3. Regulatory
Scientific
Way to move ahead
1
2
3

4. 1
Organizational
Competency &
Capability
2
Pre & Post-
market
Reviews
3
Compliance
&
Enforcement
Regulatory Issues
4
Harmonization
& Global
Compatibility
5
Inherent
resistance to
change

5. Organizational Competency & Capability
Educational
Support
Continuous
Training
Discussion
Forums
Scientific
Dialogues
Structure &
Willingness

6. Pre & Post Market Reviews
Subject based
Reviews
Cross
functional
Reviews
Summary of
Approval
Complete
Response
Communication
Signal
Detection &
Safety Alerts
Monitoring &
Lifecycle

7. Compliance & Enforcement
Site Visit, Tour &
Inspection
Practices
Inconsistent
Inspection
Approaches
Inspector
Discretion &
Polarization
Wrong Tools &
Prioritization
In predictive &
Insecure Working
Environment
Progressive
Roadmap
Uncertainty

8. Compliance and Inspections
Resource
Preparation for
Inspection
On manufacturing
site
Post Inspection
Focused
04 working
days
08 working
days
04 working
days
Integrated
90 working
days
55 working
days
15 working
days

9. Harmonization & Global Incompatibility
ICH PIC/S
Regional
Cooperation
MOU/MRA
Joint
Programs
Exchange
Programs

10. Inherent Resistance to Change
Incompetency Fear of loss Lack of Vision
Knowledge
Gap
Organizational
Ego

11. Product
Development
& Bio-studies
Critical
Quality
Attributes
Blindness
Chemistry,
Manufacturing
& Controls
Manufacturing
Controls &
Inherent
Believes
Major Scientific Issues

12. Shelf Life
& Stability
Claims
Labeling,
Promises &
Negligence
Post
marketing
Surveillance
& Vigilance
Quality
Metrics &
Culture
Major Scientific Issues

13. Product
Development &
Bio-studies
Product Understanding
Process Understanding
Chemistry, Manufacturing
& Controls/CTD
Bioequivalence, BCS & Comparative
Dissolution Profile

14. Critical Quality
Attributes
Blindness
Operational Excellence Misuse
Wrongly Applied Six/Lean Sigma Approach
Dissolution, Content Uniformity, Sterility Etc. Tests
Waiver from End Product Testing
Aseptic Operations without Media Fill, Smoke
Studies Etc.

15. Chemistry,
Manufacturing &
Controls
Drug Master File & Supplier Qualification
Scale up, Process Controls & Manufacturing
Bulk Holding, Container Closure & Stability
Transportations & Storage

16. Manufacturing
Controls &
Inherent Believes
Processing, Technology & Maintenance in
Manufacturing to demonstrate Consistency
Contamination, Cross-contamination reasonably
Heavy, Crossed Traffic Flow & Mix up potentials
Tracking, Tracing, Reliability & Integrity

17. Shelf life &
Stability Claims
Retest & Stability Studies
Meaningless Batch Sizes used for Stability
Contrary Testing Frequency with the agreed ICH
Walking with Misconceptions & Believes without
Science

18. Labeling
Promises &
Negligence
Labels contrary to Innovators
Hiding of Facts & Potential Threats
Absence of Boxed Warnings & Black Box Warning
Smart Promotion of Off Label Use

19. Post Marketing
Surveillance &
Vigilance
Quality Attributes
Complaints Management
Pharmaco-epidemiology
Pharmaco-ecomomics

20. Quality Metrics
& Culture
Indicators of Operational Reliability
Patient is Centre of Everything
Leadership Emphasis on Quality
Employee Empowerment in Decision Making

21. Regulatory Issues & Way to move Forward

22. Simplification
in Regulations
Optimization
Initiatives
Centralized
Submissions
Scientific Issues & Way to move Forward
Third Party
Inspections
Data
Standardization

23. Simplification
in
Regulations
Clear Regulations
Science based
Risk based
Predictive & Certain

24. Optimization
Initiatives
Identify & Cut Overlapping
Align with Global Language
Focus on Science & Risk
Be Smart & Progressive

25. Centralized
Submissions
Online & Computerized
Question based & Uniform
Cross Functions Integration
Efficiency Monitoring

26. Third Party
Inspections
Focus on Importing Country
Prioritization Scale
Reliance & Confidence
MOUs & MRAs

27. Data
Standardization
Common Regulatory Language
Common Format
Reliable Tools
Within ICH Guidance

28. Scientific Issues & Way to move Forward

29. Assess
Capacity &
Capability
Develop
Compliance
Strategy
Secure State
of Control
Scientific Issues & Way to move Forward
Adopt
Innovation &
Emerging
Regulatory
Sciences
Keep Wheel of
Change
Moving

30. Assess Capacity &
Capability
Be Honest First
Analyze Mfg Facilities
Analyze Quality System
Design a Clear Roadmap

31. Develop Compliance
Strategy
Identify Resources
Design Plan Strategy
Empowerment & Proceeding
Review & Critical Review

32. Secure State of
Control
Deviation & Changes
Continuous Update
Expanding Detecting Ability
Be Predictive & Proactive

33. Adopt Innovation &
Emerging Regulatory
Sciences
Knowledge Management
Strengthening the Process
Regulatory Expectations
Dashboard & Back Mirror

34. Keep Wheel of
Change Moving
Change as a Strength
Complain as a Opportunity
Integrity as a Principle
Culture of Quality