pharmaceutical scientific and regulatory practices (12 april 2017)
TRANSCRIPT
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Pakistan’s Pharmaceutical
Scientific & Regulatory Practices
Obaid Ali, R. Ph., Ph. DCivil Services Officer
Member ISPE & PDA
12 April 2017
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D
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S
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L
A
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M
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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.
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Regulatory
Scientific
Way to move ahead
1
2
3
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1
Organizational Competency &
Capability
2
Pre & Post-market
Reviews
3
Compliance &
Enforcement
Regulatory Issues
4
Harmonization & Global
Compatibility
5
Inherent resistance to
change
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Organizational Competency & Capability
Educational Support
Continuous Training
Discussion Forums
Scientific Dialogues
Structure & Willingness
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Pre & Post Market Reviews
Subject based Reviews
Cross functional Reviews
Summary of Approval
Complete Response
Communication
Signal Detection & Safety Alerts
Monitoring & Lifecycle
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Compliance & Enforcement
Site Visit, Tour & Inspection Practices
Inconsistent Inspection
Approaches
Inspector Discretion & Polarization
Wrong Tools & Prioritization
In predictive & Insecure Working
Environment
Progressive Roadmap
Uncertainty
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Compliance and Inspections
Res
ourc
e Preparation for Inspection
On manufacturing site
Post Inspection
Fo
cuse
d 04 working days
08 working days
04 working days
Inte
gra
ted
90 working days
55 working days
15 working days
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Harmonization & Global Incompatibility
ICH PIC/SRegional
Cooperation
MOU/MRAJoint
ProgramsExchange Programs
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Inherent Resistance to Change
Incompetency Fear of loss Lack of Vision
Knowledge Gap
Organizational Ego
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Product Development & Bio-studies
Critical Quality
Attributes Blindness
Chemistry, Manufacturing
& Controls
Manufacturing Controls &
Inherent Believes
Major Scientific Issues
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Shelf Life & Stability
Claims
Labeling, Promises & Negligence
Post marketing
Surveillance & Vigilance
Quality Metrics &
Culture
Major Scientific Issues
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Product
Development &
Bio-studies
Product Understanding
Process Understanding
Chemistry, Manufacturing
& Controls/CTD
Bioequivalence, BCS & Comparative
Dissolution Profile
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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.
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Chemistry,
Manufacturing &
Controls
Drug Master File & Supplier Qualification
Scale up, Process Controls & Manufacturing
Bulk Holding, Container Closure & Stability
Transportations & Storage
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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
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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
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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
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Post Marketing
Surveillance &
Vigilance
Quality Attributes
Complaints Management
Pharmaco-epidemiology
Pharmaco-ecomomics
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Quality Metrics
& Culture
Indicators of Operational Reliability
Patient is Centre of Everything
Leadership Emphasis on Quality
Employee Empowerment in Decision Making
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Regulatory Issues & Way to move Forward
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Simplification in Regulations
Optimization Initiatives
Centralized Submissions
Scientific Issues & Way to move Forward
Third Party Inspections
Data Standardization
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Simplification
in
Regulations
Clear Regulations
Science based
Risk based
Predictive & Certain
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Optimization
Initiatives
Identify & Cut Overlapping
Align with Global Language
Focus on Science & Risk
Be Smart & Progressive
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Centralized
Submissions
Online & Computerized
Question based & Uniform
Cross Functions Integration
Efficiency Monitoring
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Third Party
Inspections
Focus on Importing Country
Prioritization Scale
Reliance & Confidence
MOUs & MRAs
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Data
Standardization
Common Regulatory Language
Common Format
Reliable Tools
Within ICH Guidance
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Scientific Issues & Way to move Forward
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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
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Assess Capacity &
Capability
Be Honest First
Analyze Mfg Facilities
Analyze Quality System
Design a Clear Roadmap
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Develop Compliance
Strategy
Identify Resources
Design Plan Strategy
Empowerment & Proceeding
Review & Critical Review
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Secure State of
Control
Deviation & Changes
Continuous Update
Expanding Detecting Ability
Be Predictive & Proactive
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Adopt Innovation &
Emerging Regulatory
Sciences
Knowledge Management
Strengthening the Process
Regulatory Expectations
Dashboard & Back Mirror
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Keep Wheel of
Change Moving
Change as a Strength
Complain as a Opportunity
Integrity as a Principle
Culture of Quality