EXPLORING THE FUTURE DIGITAL

TRANSFORMATION 4.0& THE

REVOLUTIONARY IN PHARMA
INDUSTRY

By: Ir. Dr. Nizamil Fairuz Yahya, P.Eng., ACPE, P.Tech., Ph.D.,
PharmEng Technology, Malaysia

Date: 23 May 2024

KL Office: 1 Sentral, Level 16, Jalan

Stesen Sentral 5, KL Sentral, 50470, KL
Johor Office: 9 & 9A, Jalan Bukit Impian,
Taman Impian Emas, 81300 Skudai, Johor
Tel: +603 27879141
 AGENDA
INTRODUCTION

EXPLORING THE FUTURE DIGITAL

TRANSFORMATION 4.0
THE REVOLUTIONARY OF THE DIGITAL
TRANSFORMATION 4.0
EXAMPLE OF DIGITAL TRANSFORMATION 4.0 &
APPLICATION

THE CHALLENGES OF IMPLEMENTING AN

IMMEDIATE CHANGE IN PHARMA INDUSTRY

HOW CAN WE IMPLEMENT WITH COMPLIANCE?

Business Use Only| PharmEng Technology | 2
 INTRODUCTION

Presentation Title Business Use Only| PharmEng Technology | 3

PHARMENG
25+ Years of Consulting
AT A Experience

GLANCE Pharmaceuticals & Life

Sciences focused

300+ Consultants &

Engineers Globally

13 Offices Across the Globe

Diversified Clients &

Capabilities

Kneat Solutions Partner &

Valgenesis Partner
SENIOR
LEADERSHIP
TEAM, ASIA Executive VP & Managing
Director, Asia & Spain
Kenny Peng

Managing Director and Project Business Development Director, Regulatory Affairs Director, Asia Business Development Director,
Governance, Asia Asia Korea
Ir. Dr. Nizamil Fairuz Yahya Dody Tanusubandi YeeJu Chen Sunmi Kim
 GMP TEAM
SOUTHEAST
ASIA
PrM & SME
CSA/CSV, CQV, Technology
Transfer, Process Validation
Ts. Izwan Firdaus
Principal Engineer
SME Lab & Process Validation, Cleaning
Validation & Sterility Assurance
Shaiful Zaini
Senior Validation Engineer
SME CQV, QA/QC, AMV & Lab Testing
Ainaa Balqis
Validation Engineer
SME F&U, CSV & CQV, Process Equipment
Khairunajwa
Managing Director and Project
Governance, Asia
Project Director
SME Project Management, Technology Transfer, CQV,
Process Validation, AMV & AMT Ir. Dr. Nizamil Fairuz Yahya
PM & SME PM & SME PM & SME
Ts. Ahmad Safuan
Facilities, Utilities, Cleanroom, Process Validation, Pilot Scale Lab & Process Validation, Cleaning
W/H & Storage Areas Project, CQV, Technology Transfer Validation & Sterility Assurance
Faizul Ezmat Qadly Ameen Salwa Hussin
Senior Validation Engineer Senior Validation Engineer Senior Validation Engineer Senior Consultant
Principal Engineer Principal Engineer Senior Validation Engineer Senior Validation Engineer SME Facilities & Utilities, Process SME CQV, Process Equipment
SME F&U, CQV & CSV, Process Equipment
SME Process Equipment & CSV SME F&U, CQV, Process Equipment
Qualification, Tech Transfer
SME CSV, Process Equipment & SME IT-CSV, Lab & Process Equipment &
Equipment & Tech Transfer Qualification & QMS SME Regulatory Affairs
Qualification, CSV & Tech Transfer Tech Transfer Tech Transfer
Zamiruddin Hamdan Isa Azizul Izwan Dzairol Adzriem Hafiz Ambar Dr. Hotimah Norashikin Amalina Yusoff
Sr. Engineering Admin Senior Validation Engineer Senior Validation Engineer Senior Validation Engineer Validation Engineer
Senior Validation Engineer Senior Validation Engineer SME QA & Engineering Compliance, SME PMO, CSV, CQV Process Equipment, Tech SME CQV, CSV, Tech. Transfer & Equipment SME CQV & Lab Qualification, HVAC &
Consultant
SME QMS, Doc Control, QA & Engineering SME CQV & Lab Qualification, Process SME CSV, Automation, Process Equipment &
Compliance Equipment
Administration Tech Transfer Transfer & Process Validation Qualification Cleanroom, Process Equipment SME Regulatory Affairs
Nur Farayu Nur Shima Nasyrah Azman Syazirol Mazlan Luqman Nizam Khairin Rahim Ain Syafiqah Shafiqah
Validation Engineer Validation Engineer Validation Engineer Validation Engineer Validation Engineer Validation Engineer Validation Engineer Consultant
SME F&U, CSV & CQV, Process Equipment SME F&U, CQV, Process Equipment SME F&U, CQV, Process Equipment SME F&U, CQV, Process Equipment SME F&U, CQV, Process Equipment SME F&U, CQV, Process Equipment SME F&U, CQV, Process Equipment SME Regulatory Affairs
Sarah Sapahi Zarul Izzat Zulhilmi Yunus Hazmyl Ismail Yazed Rahman Nur Syahirah Rida Hadirah Leow Pui Mun
GMP TEAM
SOUTHEAST
ASIA
Managing Director and Project
Governance, Asia

Ir. Dr. Nizamil Fairuz Yahya

Business Development Director,
Asia

Dody Tanusubandi

Validation Engineer Validation Engineer Validation Engineer Consultant

Marketing Executive Senior Quality & Halal Consultant SME QA, Facilities & Utilities, CQV & CSV, Lab & SME Facilities & Utilities, Process
SME Technical Services & Tech Transfer, Process Validation, Quality SME Facilities & Utilities, Process SME Regulatory Affairs
Process Equipment Equipment & Tech Transfer
Systems, and Quality Audits Equipment & Tech Transfer

Roseline Tio Tatiani Hartanti A. Citra Rachmawati Abdi Setyadi Yuki Lavigne Nur Azizah
 OUR Europe

OFFICE
DENMARK
North America IRELAND
SPAIN
CANADA
(ON) USA

S
(NC, GA)

Asia-Pacific
INDONESIA
ATLANT MALAYSIA
IC OCE SINGAPOR
AN E TAIWAN

PACIF
PHARMENG IC OC
EAN
TECHNOLOGY INDIA
N OCE
Latin America
HAS 13 PUERTO
AN
RICO BRAZIL
OFFICE DOMINICAN
REPUBLIC
LOCATIONS
ACROSS THE
GLOBE
Multi-Discipline Organization
Malaysia Office 1 Sentral, Level 16,
Processes: mRNA, Cell Cultures, Aseptic Filling, OSD Jalan Stesen Sentral 5, KL Sentral, 50470, KL

Facilities: HVAC & Cleanroom Tel: +603 27879141

Equipment: Manufacturing Process, Laboratory & Support SPECIALIZED GMP & REGULATORY AFFAIRS
Clean Utilities: PSG, WFI, Gases Systems FOR LIFESCIENCE INDUSTRY
PharmEng Technology (“PharmEng”) Malaysia is a multinational, fully-integrated professional engineering and
Automation Systems: BAS, EMS, ERP, LIMS, SCADA
Engineering Design Services consulting company serving the regulated lifescience industries in pharmaceutical, biotechnology, and medical
Support Systems: CIP, SIP, Instrumentation & Control device. As a full-solution provider, PharmEng delivers the comprehensive capability to assists our clients
Process Design & Utilities throughout the entire lifecycle of a regulated product – from engineering design, product development,
commissioning, qualification & validation (“CQV”), to regulatory affairs.
Architectural & Facility

Automation: Software / Hardware

“Your Road-Map for Lifescience
Mechanical, Electrical & Piping (MEP) Industries Excellence”
Instrumentation & Control

Commissioning,
Technical SpecificationQualification & Validation

Services
Design Review
Risk Management Tools: SIA, CA, FRA
Commissioning / Qualification / Validation Master Plans

Commissioning Test Procedures : Facility, Utilities, Process,

Equipment and Automation

Qualification (DQ/IQ/OQ/PQ) Protocols: Critical Utilities,

Equipment and Instrument, Process System, Controlled

Temperature Units, Process Control Systems
Regulatory Affairs Services
Validation Activities: Process, Cleaning,
Regulatory Agency Liaison
Validation, Thermal Validation, Method Validation
Drugs Clinical Trial Application
https://www.pharmeng.com
Computer Systems
https://www.linkedin.com/
company/pharmeng-technology
https://www.youtube.com/PharmEng
Technology/Experts in Life Sciences
Technology and Regulatory Affairs

New Drug Application/Submission (NDA/NDS/PLA/EU)

Abbreviated New Drug Application/Submission (ANDA/ANDS)

Package Insert/Product Monograph/Labelling

ASIA Team CSV Support

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Malaysia
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Indonesia

10
EXPLORING THE FUTURE DIGITAL
TRANSFORMATION 4.0
INTRODUCTION
HISTORY OF DIGITAL TRANSFORMATION

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EXPLORING THE FUTURE DIGITAL
THE FRONTIER OF DIGITAL TRANSFORMATION
TRANSFORMATION 4.0
 Internet of Things

 Blockchain Technology

 Machine Learning

 Artificial Intelligence

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EXPLORING THE FUTURE DIGITAL
THE FRONTIER OF DIGITAL TRANSFORMATION
TRANSFORMATION 4.0
 Internet of Things in Pharma 4.0
IoT systems integration of four distinct components:
 Sensors/Devices, Connectivity, Data Temperature 4G / Ethernet

Processing, and a User Interface.

GxP IoT Solutions provides …for both ongoing monitoring and
environmental parameters project-based logging, combined
Advantages of IoT include the following: including temperature, humidity,
and pressure …
with centralized management and
GxP validation documentation
 Enables access to information from anywhere at
any time on any device.
 Improves communication between connected
electronic devices.
Monitoring / GxP Validation
 Enables the transfer of data packets over a Logging
Humidity Pressure
connected network, saving time and money.

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EXPLORING THE FUTURE DIGITAL
THE FRONTIER OF DIGITAL TRANSFORMATION
TRANSFORMATION 4.0
 Blockchain Technology
 Blockchain technology is an
advanced database mechanism
that allows transparent
information sharing within a
business network.
 Stores Data in blocks and linked
together.
 Simplifies processes
 Reducing processing time
 Managed & Secured data

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 EXPLORING THE FUTURE DIGITAL
THE FRONTIER OF DIGITAL TRANSFORMATION
TRANSFORMATION 4.0
 Machine Learning
 ML is a sub-discipline of
AI.
 ML primarily involves the
ability of computers to
learn a task by monitoring
data and using statistical
tools in order to derive
some general knowledge
from these data (via the
development of
mathematical
relationships) without
external input or prompt
(McCarthy et al., 2004)
EXPLORING THE FUTURE DIGITAL
THE FRONTIER OF DIGITAL TRANSFORMATION
TRANSFORMATION 4.0
 Artificial Intelligence

 AI involves the integration of digital data and computational analysis for the purpose of making
decisions normally made by humans (McCarthy and Thomason, 1989).
 AI that rely on computer-based intelligence may involve reasoning, problem solving, learning, and
decision-making among others.
 The application of AI in pharmaceutical manufacturing has already begun with examples including
the use of machine vision technology replacing:
 human visual inspection of packaging, caps and vials;
 predictive equipment maintenance to reduce disturbances,
 risks, and production downtime; and automated quality control
 scheduling of analytical testing, continuous process quality assurance, and enhanced data
integrity.

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EXPLORING THE FUTURE DIGITAL
THE FRONTIER OF DIGITAL TRANSFORMATION
TRANSFORMATION 4.0
 Artificial Intelligence

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 THE REVOLUTIONARY OF THE
DIGITAL TRANSFORMATION 4.0

Presentation Title Business Use Only| PharmEng Technology | 19

REVOLUTIONARY
HOW DIGITAL TRANSFORMATION 4.0 CHANGE IN THE PHARMA INDUSTRY?
REVOLUTIONARY
HOW DIGITAL TRANSFORMATION 4.0 CHANGE THE PHARMA INDUSTRY

PHARMA 4.0 IS TRANSFORMING CONTROL IN THE

MANUFACTURING PROCESS BY:
 THE TECHNIQUES USED IN ADVANCED ANALYTICS, MACHINE PROCESSING &
PREDICTION AND IMPROVED MANUFACTURING EFFICIENCIES

 PHARMA 4.0 TECHNOLOGIES CAN IDENTIFY QUALITY ISSUES EARLY IN THE

MANUFACTURING PROCESS.

 IMPROVED SUPPLY CHAIN MANAGEMENT

REVOLUTIONARY
HOW DIGITAL TRANSFORMATION 4.0 CHANGE THE PHARMA INDUSTRY
 THE USE OF ADVANCED ANALYSIS & MACHINE PROCESSING & PREDICTION
AND MANUFACTURING EFFICIENCY

 Operational Efficiency  Improved Manufacturing

 Real-time Monitoring  Supply Chain Management

 Data Analysis  Blockchain for Transparency

 Faster Time to Market  Streamlined Regulatory Compliance

REVOLUTIONARY
HOW DIGITAL TRANSFORMATION 4.0 CHANGE THE PHARMA INDUSTRY

 PHARMA 4.0 TECHNOLOGIES CAN IDENTIFY QUALITY ISSUES EARLY IN THE

MANUFACTURING PROCESS.

 Internet of Things (IoT)

 Real-time Monitoring and Sensors

 Advanced Analytics & Data Analytics

 Predictive Maintenance
REVOLUTIONARY
HOW DIGITAL TRANSFORMATION 4.0 CHANGE THE PHARMA INDUSTRY

 IMPROVED SUPPLY CHAIN MANAGEMENT

 Improved Tracking Management

 Improved Inventory

 Improved Distribution

 Eliminating Counterfeit
REVOLUTIONARY
RISK-BENEFIT & OPPORTUNITIES OF 4.0 INDUSTRIAL REVOLUTION FOR PHARMA INDUSTRY

 It takes time and capital to adopt the

 The production process is fast &
latest technology
efficient
 Upgrade skill personnel
 Eliminates human error
 Maintaining complex software,
 Improve product quality and prevent
hardware, automation, machines
recalls
 Handling big data (integrity, security,
 Improve materials tracking
storage)
RISK BENEFIT
 EXAMPLE OF DIGITAL
TRANSFORMATION 4.0
& APPLICATION

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EXAMPLE OF DIGITAL TRANSFORMATION 4.0 &
APPLICATION
MANUFACTURING EXECUTION SYSTEMS (MES)
EXAMPLE: IMPLEMENTING MES
THE CHALLENGE: In a challenging environment,
manufacturers of pharmaceuticals,
biopharmaceuticals, and cell and gene therapies must
remain competitive and leverage digital
transformation to achieve operational excellence.

MANUFACTURING EXECUTION SYSTEMS (MES) are

playing a crucial role in the digital ecosystem of
manufacturing operations.

MES controls, monitors, and documents the processes

digitally and in real time across the entire production
cycle. It enables the systems efficiency, lower the fault
rate, and reduce production costs.

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 THE CHALLENGES OF
IMPLEMENTING
IMMEDIATE CHANGE IN
PHARMA INDUSTRY

Presentation Title Business Use Only| PharmEng Technology | 28

THE CHALLENGES OF IMPLEMENTING IMMEDIATE
CHANGE IN PHARMA INDUSTRY
WHAT ARE THE CHALLENGES?
 REGULATORY CHALLENGES: Pharmaceutical Industries are Stringently Regulated Industries.
The Industries Has Many Stringent Requirements.

 HUMAN LABOUR CHALLENGES: Potential displacement of human workers as advanced technologies

is integrated into industries which lead to job losses and shift labor market dynamics.

 LOGISTIC CHALLENGES: Potential disruption of traditional supply chains. The use of advanced
technologies in production may emphasize customization and flexibility, leading to the
decentralization of manufacturing and the emergence of smaller supply chains.

 CYBER-ATTACK RISK: Rises as the use of connected devices and networks increases.

 TECHNICAL CHALLENGES: Shifting policies and regulations concerning data privacy, intellectual
property, and trade.

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 HOW CAN WE IMPLEMENT
WITH COMPLIANCE?

Presentation Title Business Use Only| PharmEng Technology | 30

HOW CAN WE IMPLEMENT WITH COMPLIANCE?
PLANNING PHASE

PLANNING TO IDENTIFY AND ANALYZE THE PROBLEM OR

OPPORTUNITY FOR DIGITAL TRANSFORMATION CHANGES IN
PHARMA INDUSTRY:

 UNDERSTAND REGULATORY REQUIREMENTS

 TRAINING AND AWARENESS

 QUALITY MANAGEMENT SYSTEMS (QMS)

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HOW CAN WE IMPLEMENT WITH COMPLIANCE?
COMPLIANCE GUIDANCE PHASE

 GAMP 5 Edition 2 introduced the new Appendix D11 – Artificial Intelligence and Machine
Learning (AI/ML) (1), which provides guidance on how to ensure compliant integration and
fitness for use in a validated environment

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HOW CAN WE IMPLEMENT WITH COMPLIANCE?
IMPLEMENTATION PHASE

IMPLEMENTING TO EXECUTE THE PLANNING AND MAKE IT EFFECTIVE:

 ELECTRONIC RECORDS AND SIGNATURES
 RISK MANAGEMENT
 VALIDATION PROCESSES
 CONTINUOUS MONITORING & IMPROVEMENT
 DATA SECURITY & PRIVACY
 CROSS-FUNCTIONAL COLLABORATION

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THANK YOU

• Ir. Dr. Nizamil Fairuz Yahya

• nizamil.f@pharmeng.com
• www.pharmeng.com

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