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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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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.
1
Organizational Competency &
Capability
2
Pre & Post-market
Reviews
3
Compliance &
Enforcement
Regulatory Issues
4
Harmonization & Global
Compatibility
5
Inherent resistance to
change
Organizational Competency & Capability
Educational Support
Continuous Training
Discussion Forums
Scientific Dialogues
Structure & Willingness
Pre & Post Market Reviews
Subject based Reviews
Cross functional Reviews
Summary of Approval
Complete Response
Communication
Signal Detection & Safety Alerts
Monitoring & Lifecycle
Compliance & Enforcement
Site Visit, Tour & Inspection Practices
Inconsistent Inspection
Approaches
Inspector Discretion & Polarization
Wrong Tools & Prioritization
In predictive & Insecure Working
Environment
Progressive Roadmap
Uncertainty
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
Harmonization & Global Incompatibility
ICH PIC/SRegional
Cooperation
MOU/MRAJoint
ProgramsExchange Programs
Inherent Resistance to Change
Incompetency Fear of loss Lack of Vision
Knowledge Gap
Organizational Ego
Product Development & Bio-studies
Critical Quality
Attributes Blindness
Chemistry, Manufacturing
& Controls
Manufacturing Controls &
Inherent Believes
Major Scientific Issues
Shelf Life & Stability
Claims
Labeling, Promises & Negligence
Post marketing
Surveillance & Vigilance
Quality Metrics &
Culture
Major Scientific Issues
Product
Development &
Bio-studies
Product Understanding
Process Understanding
Chemistry, Manufacturing
& Controls/CTD
Bioequivalence, BCS & Comparative
Dissolution Profile
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.
Chemistry,
Manufacturing &
Controls
Drug Master File & Supplier Qualification
Scale up, Process Controls & Manufacturing
Bulk Holding, Container Closure & Stability
Transportations & Storage
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
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
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
Post Marketing
Surveillance &
Vigilance
Quality Attributes
Complaints Management
Pharmaco-epidemiology
Pharmaco-ecomomics
Quality Metrics
& Culture
Indicators of Operational Reliability
Patient is Centre of Everything
Leadership Emphasis on Quality
Employee Empowerment in Decision Making
Simplification in Regulations
Optimization Initiatives
Centralized Submissions
Scientific Issues & Way to move Forward
Third Party Inspections
Data Standardization
Optimization
Initiatives
Identify & Cut Overlapping
Align with Global Language
Focus on Science & Risk
Be Smart & Progressive
Centralized
Submissions
Online & Computerized
Question based & Uniform
Cross Functions Integration
Efficiency Monitoring
Third Party
Inspections
Focus on Importing Country
Prioritization Scale
Reliance & Confidence
MOUs & MRAs
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
Assess Capacity &
Capability
Be Honest First
Analyze Mfg Facilities
Analyze Quality System
Design a Clear Roadmap
Develop Compliance
Strategy
Identify Resources
Design Plan Strategy
Empowerment & Proceeding
Review & Critical Review
Secure State of
Control
Deviation & Changes
Continuous Update
Expanding Detecting Ability
Be Predictive & Proactive
Adopt Innovation &
Emerging Regulatory
Sciences
Knowledge Management
Strengthening the Process
Regulatory Expectations
Dashboard & Back Mirror