Cover Page Lorem Ipsum · 2019-06-07 · Connecting Pharmaceutical Knowledge ispe.org Pharma 4.0...

Pharma 4.0Departure Into a New Dimension

Lothar Hartmann, Ph.D.

Connecting Pharmaceutical Knowledge ispe.org 2

A Story about

Algorithms and Filter Bubbles

Connecting Pharmaceutical Knowledge ispe.org

Pharma 4.0Departure into a New Dimension

1. Introduction Into the Topic

2. Pharma 4.0 – Operating Model

3. Pharma 4.0 - Enablers

4. Holistic Control Strategy

5. From Pharma 2.0 to Pharma 4.0

6. How the Future Can Look Like

Source: Lawrence Yu, Ph.D. Deputy Director, Office of Pharmaceutical Quality FDA Center for Drug Evaluation and Research

Future of Pharmaceutical Quality and the Path to Get There, 3rd PQRI/FDA Conference on Advancing Product Quality, March 22-24, 2017

„Even as it [the pharmaceutical industry] invents futuristic new drugs, itsmanufacturing techniques lag far behind those of potato-chips andlaundry-soap makers.”

‚The Wall Street Journal’, September 3, 2003

What is the Challenge we are faced with?A look into history....

ISPEs initiative

to provide

guidance for the

transformation

process

Where we are coming from...

ICH Q10

ICH Q10 +

Digitisation

Acatech

Ind.4.0

Pharma 4.0

The Idea Behind

ICH Q10 plus digitisation

(developed by ISPE)

The Operating Model

The Acatech Model

Merging the Concepts

The Result

• Architecture

• Traceability

• Data Management

• Mindset

• Risk based decision

taking

• Anxiety-free

communication

• Networks

• Lifecycle approach

• Process based

• Infrastructure

• Availability

• Interface Human / Machine

ISPE Working Groups

• PQS

• QRM

• KM

• Data Integrity

• Digital Maturity

Pre-requisits for Pharma 4.0

Process as part of a process map

Draw flow chart

Determine scope, objective, provider &

receiver

List activities performed

Describe each activity

Consider risks06

Communicate process09

Set up process description 07

Consider optimization

Agreement achieved?

Dept. X

Dept. Y

Dept. Z

Activity

ActivityDecisionyes

Enabler:

Pharmaceutical Quality System

Enabler:

Pharmaceutical Quality System

The change towards a PQS entails a cultural change within a company

Ignorance

• Business as usual

• No need for

processes

Stand-alone Solutions

• Important processes are

described, but not

synchronized with one

another

PQS• Processes are the

basis for the

company

• Departments work

together independent

of functions

• Processes are

adjusted towards a

company-wide

system of objectives

Cultural change

Enabler:

Quality Risk Management

anagem

Risk ReviewRisk Communication

Risk Assessment

Risk Evaluation

InitiateRisk Management Process

unacceptable

Risk Control

Output / Results of theRisk Management Process

Risk Analysis

Risk Reduction

acceptable

Risk Identification

Risk Communication

Review Events

Risk Acceptance

Enabler:

Quality Risk Management

Enabler:

Knowledge Management

Facts:

Numbers, text

Relationship:

Facts within context

Guidance:

Utilisation of Information

Learning:

Application of Knowledge

Result of pharmceutical

application to Knowledge

Management?

Enabler:

Knowledge Management

Enabler:

Data Integrity

“The degree to which a collection

of data is complete, consistent,

and accurate.”

Data Lifecycle ≠ Computer Lifecycle

Enabler:

Data Integrity

Source: Acatech Study Industry 4.0 Maturity Index, April 2017

Enabler:

Digital Maturity

<<<<<<

Information Systems

Culture

Resources

Visibility

Transparency

Predictability

Adaptability

Computerization

Connectivity

Organizational

Structure

Enabler:

Digital Maturity

Pharma 4.0 is more than a

technology revolution.

A successful transformation

requires the balance of 4

segments and 6 maturity levels

Extended ICH Q10 Model

Holistic Control Strategy

PHARMA 4.0:Digital Maturity & Data Integrity by Design

Knowledge Management & Quality Risk Management

Process Performance &

Product Quality Monitoring SystemCorrective Action

Preventative Action (CAPA) System

Change Management

Management Review

Elements

Enablers

Management Responsibilities

PHARMA 4.0: Resources: Digitalization, Workforce 4.0, Available & Qualified

Information Systems: Holistic Value Network Integration & Traceability

Organization & Processes: Holistic Control Strategy, Lifecycle Management

Culture: Communication & Decision Making

Enablers

New PQS

Elements

Product DiscontinuationCommercial ManufacturingTechnology TransferPharmaceutical Development

Investigational Products

• Control Strategy− Based on ICH Q10

− Product-related

− Established during development

• Manufacturing Control Strategy− Process-related

− Defines Master Batch Record

− Enables ongoing process verification

• Holistic Control Strategy− Systematic and controlled concept for developing and managing information

throughout entire period

− End-to-end view (lifecycle management)

Definitions

Control

Strategy

Manufacturing

Control Strategy

Holistic

Control

Strategy

Implementation Methodology

4. “Optimized” Data Flow

2. Process Data Maps

1. Process Maps

3. Critical Thinking

current

Control Strategy

Holistic

Control Strategy

Without detailed knowledge of the processes, an

organisation of the data flow can not be made.

Applying known standards,

tools and methods to determine

actual business &

manufacturing processes:

• Process Maps

• Flow Charts

• Cross-functional Maps

• RACI Matrix

• Interfaces

• KPIs

• …

Step 1: Process Maps

Process Maps “Optimized” Data FlowProcess Data Maps Critical Thinking

The Way Towards A Holistic Control Strategy Lifecycle Management

Determine actual data which

can be obtained from the

business & manufacturing

processes:

• What data are available?

• For which purpose are data

• Who enters or changes data

and why?

• What kinds of data errors

may appear?

• How do data move through

an organisation?

• …

Re-Assess and challenge

actual processes and Data

Flows to:

• Conduct data analysis

• Identify essential data

• Identify redundant data

• Eliminate unused data

• Detect different formats of

the same data

• Question interfaces (manual

& automated)

• Detect data integrity issues

• …

Re-Design and optimize actual

processes, Data Flows and

interfaces:

• Harmonize data formats

• Reduce amount of data

• Improve data availability

• Dataflow among networks

• Implement ALCOA/ALCOA+

Principles

• enable data besed decisions

• …

Step 2: Process Data Maps

processes:

and why?

may appear?

an organisation?

• …

actual business &

• Process Maps

• Flow Charts

• RACI Matrix

• Interfaces

• KPIs

• …

Flows to:

the same data

& automated)

• …

interfaces:

Principles

• …

Step 3: Critical Thinking

Flows to:

the same data

& automated)

• …

actual business &

• Process Maps

• Flow Charts

• RACI Matrix

• Interfaces

• KPIs

• …

processes:

and why?

may appear?

an organisation?

• …

interfaces:

Principles

• …

Step 4: "Optimized " Data Flow

interfaces:

Principles

• …

Flows to:

the same data

& automated)

• …

processes:

and why?

may appear?

an organisation?

• …

actual business &

• Process Maps

• Flow Charts

• RACI Matrix

• Interfaces

• KPIs

• …

Flow of Data

Manufacturing Control Strategy

Commercial ManufacturingTechnology TransferPharmaceutical Development

Investigational ProductsProduct Discontinuation

ICH Q10: Knowledge Management & Quality Risk Management

Data Integrity & Digital Maturity

Control Strategy

Utilisation of Data

Wisdom

Knowledge

Information

Data Data Capturing / Generation

Product Process

Data Analytics

Value chain Management

Value Chain Life CycleManagement

Data Mining

Trend Reporting

Product Life Cycle Management

Commercial ManufacturingTechnology TransferPharmaceutical Development

Investigational ProductsProduct Discontinuation

tManufacturing Control Strategy

Enabler

Pharma 2.0 – Current Situation

• Non-effective and efficient manufacturing

• Improper handling of data

• Exploding amount becomes unmanageable

• Generate data, but don’t use it

• Too much paper (paper silos)

• Manual review no longer adequate

• 2.0 does not connect systems

• Missing interfaces between systems

• No use of real time data

• No decision making by automated systems

• Too many ‘home-made’ systems

• Silo culture

• No clear definition of processes, data flow and responsibilities

• Regulated environment slows down innovation

Pharma 4.0 – The Desired State

• Harmonised platforms (exchange of data among systems)

• Data based decisions

• Self-explaining rather than training (e.g. video SOPs)

• Vitual communities

• Collaboration with universities and authorities

• Independet of locations

• Cloud solutions and cyber security

• Knowledge Management

• Digital acceptance of decisions instead of 4 eyes principle

• Dynamic submissions (eCTD)

• Real time control and self-oprimisation

• Robust decisions

• Saving of resources

• No drug shortage

A look into the crystal ball

Operations

✓ Production Schedule Attainment

✓ Cycle Times

✓ Yield

✓ Right First Time

✓ Breakdown times

✓ Stock Level

✓ Raw Materials delivery

✓ Transportation Schedule Attainment

These tasks can be

virtually be done from

anywhere in the world

Operations

Engineering

✓ Preventive / Predictive Maintenace Program Schedule Attainment

✓ Calibration Schedule Attainment

✓ Stock Level of Critical Equipment

✓ Projects on Time

✓ Qualification / Validation Status

✓ Power Supply

✓ HVAC Status

Service group of people

required to keep

production running

Engineering

Regulatory Affairs

Will become

mediators between

company and

authority

Quality Assurance

✓ Batch Record Review

✓ Release Time

✓ Deviations

✓ CAPAs

✓ APR / PQR

✓ Complaints

✓ Overdue Items

✓ Ensuring preventive/predictive maintenance and calibration

• Approving CMO

• Approving SOPs and MBR

• Approving Changes

• Conducting Audits

Now, what will be the task of the Quality Department

in the future when we operate in a Pharma 4.0 world

The Quality Department

will be the

Master of Data…

…or with other words:

Knowledge

Management

Idea Execution

Judgement,

Coordination &

Control

The evolution of mankind…..

….has brought us to Industrialisation.

Let’s take the chance that digitalisation will

bring us back into the right position.…..

Thank You for Your Attention!

Phact GmbH · Christoph Merian-Ring 11 · CH-4153 Reinach BL · +41 (0)61 717 14 15 · info@phact.ch · www.phact.ch

Cover Page Lorem Ipsum · 2019-06-07 · Connecting Pharmaceutical Knowledge ispe.org Pharma 4.0...

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