Transcript How will PAT and new GMP's impact current & future

Plug and Play PAT Anyone?
Presented at AutomationXchange
August 2005
Outline
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Thought for the day!
Acknowledgements
Top issues
Why GMPs for the 21st Century?
PAT at Pfizer
Impacts on Architecture/Infrastructure
Current Challenges
Common PAT Software
Call for action
Desired outcome: Plug and Play PAT Everyone!
©Pfizer, Inc
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Pillai & Warman
Thought for the day
“…Be the change you want to see in the
world…” M.K.Gandhi
©Pfizer, Inc
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Acknowledgements
• Martin Warman
Sr. Manager/Team Leader of Process Analytical Support
Group, Pfizer Global Manufacturing
• Jeff Miller
Strategic Sourcing Manager, Pfizer Global Sourcing
Common PAT Software Project Core Team Member
©Pfizer, Inc
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Top issues
• Patent expiries
• Pressure to reduce drug costs
• Challenges to IP
• Counterfeiting & Piracy
• Unmet needs
• Regulatory Pressures
Unprecedented Need For Change
©Pfizer, Inc
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What is GMPs for the 21st Century?
• FDA focus on manufacturing
– Manufacturing is inefficient
– Industry has failed to innovate
– Compliance record is unacceptable
• Recognition that barriers to adoption of
innovation and continuous improvement
– PAT framework
• Advances in quality systems & science
• GMP regulations has not changed
Report on Pharmaceutical GMPs for 21st Century
was published©Pfizer,
September
2004
Inc
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GMPs for the 21st century
• Focus on risks to public health
• Risk-based orientation
• Mfg. Science based policies and standards
• Integrated quality systems approach
• Harmonization & alignment with other
regulations
FDA is providing science and risk based guidance documents
related©Pfizer,
to GMPs
Inc
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Fundamental shifts
• Corrective action to continuous improvement
• Continuous quality verification
–Quality by testing to Quality by design
• Diverse supply chains
• New measurements
• More information about the process
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Role based
Event based
Scalable, reliable, flexible, secure and timely information
required in Pharmaceutical
Manufacturing
©Pfizer, Inc
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PAT at Pfizer
• Analytical technology used to gain more
information on the process to identify sources
of variability
• Not lab based, although measurement
techniques similar
• Not just regular measurement
– Temperature, pH, Pressure
– Complex data and measurement technology
• At-line
• In-line
©Pfizer, Inc
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Why PAT?
• Key enabler for Mfg. Science
–Establish Product/Process Knowledge- CtQA
–Process capability Data – Ability to meet CtQA
–Process understanding…Know all variability
• Technology barriers are dissolving
–What took hours or days now is possible in real-time
–Real-time feedback and control now using PAT for all
CtQA’s is feasible.
–New measurements being characterized everyday
©Pfizer, Inc
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Block diagram PAT measurement
•Control spectrometer
•Acquire data
•Run predictions
•Displays prediction
•Store data
•Maintain calibration, event log etc
•Generate methods
•Pre-treat spectral data
•Extract constituent data
Data Analysis
Method
Spectrometer
Configuration
Hist
PAS
System
Functions
Tank
DB
PC
AT
Detector
Data Modelling
Process
Configuration
About 3000 floating point
values for 500 samples
PAT is a tool as a part of a system to verify process robustness
©Pfizer, Inc
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Impacts on Infrastructure/Architecture
Process
Justify
Risk Analysis
Understanding Innovation & Mitigation
R&D
Informatio
n
Multi-factorial
Analysis
Customers
Shared Knowledge
Management
Over Product Lifecycle
Lab
Analysis
On-line
Measureme
nts
Raw
Materials
Process
Design
Weigh
&
Dispense
Continuous
Improvement
Process
Control
Processing
Packaging
Final
Product
Distribution
©ARC Advisory Group. Used with permission
New requirements
This requirement poses new challenges to current infrastructure
©Pfizer, Inc
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Current IT Challenges
• Islands of Automation
• Platform based initiatives
• Infrastructure planning driven by point
application needs
• Domain silos (Process control, IT)
• Tactical Solutions archipelago
• Measurement System Capabilities
• Need for to manage and facilitate collaborative
views on process information in near real-time
This is not about technology alone.
Collaboration is critical to©Pfizer,
overcome
these
challenges.
Inc
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What can we do till we get there?
• Standardize measurements
• Standardize data
• Identify process owners and uses for data
• Master plan: Impact assessment on
architecture, applications, infrastructure
• Leverage existing infrastructure
–Slipstream new capabilities
• Lay the foundation first, build as you go
Build bridges to cross the chasm
©Pfizer, Inc
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Call for action
• Common PAT Software
– Standard modelers, interfaces
• Standardize Data
– Recipes, Item masters, Measurement data, Production
Information
– Develop life-cycle management models for data
• Standardize schema to exchange information
• Migrate to Single Integrated Architecture
We are not in this alone.
©Pfizer, Inc
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Common PAT Software
• Set up and run Process Analyzers
• Provide a common modeling environment
• Single environment to build and configure
Process Analyzers
• Facilitate archiving of PAT data into storage
systems
©Pfizer, Inc
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Common PAT Software
Functional Architecture
Design of Experiment
PAT Common User Interface
Process
Control
System
On-line
Prediction & Monitoring
PAT
Instrument Control
Off-line
Method Builder
Off-line
Retrieval, Analysis
Common Data Access
Storage
Instrument and Sensor Interface
Sensors/Control
Devices
Protocol Adapter
Protocol Adapter
Instrument
Sensor
Protocol Adapter
Protocol Adapter
Prop. Inst. Software
Instrument
Transient
PAT Data
Protocol Adapter
Unit
Operation
Future
Inst
PROCESS
©Pfizer, Inc
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PAT Paradigms of Use
PAT Mode: Monitor
PAT Mode: Control
Method
•Instrument Control
Interface
•Instrument Control
•Data Analysis
Interface
•Data Analysis
PAT Mode: Optimize
•Instrument Control
Modeller
•Data Analysis
Interface
•Controller Interface
•Method Builder
•Predictive Modeling
•Controller Interface
Method
Analyzer
Analyzer
Process
Process
Controller
©Pfizer, Inc
Analyzer
Controller
Process
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