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.

Regulatory

Scientific

Way to move ahead

1

2

3

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

Regulatory Issues & Way to move Forward

Simplification in Regulations

Optimization Initiatives

Centralized Submissions

Scientific Issues & Way to move Forward

Third Party Inspections

Data Standardization

Simplification

in

Regulations

Clear Regulations

Science based

Risk based

Predictive & Certain

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

Data

Standardization

Common Regulatory Language

Common Format

Reliable Tools

Within ICH Guidance

Scientific Issues & Way to move Forward

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

Keep Wheel of

Change Moving

Change as a Strength

Complain as a Opportunity

Integrity as a Principle

Culture of Quality