Plug and Play PAT Anyone?

Presented at AutomationXchange

August 2005

Pillai & Warman ©Pfizer, Inc Page: 2

Outline

• 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!

Pillai & Warman ©Pfizer, Inc Page: 3

Thought for the day

“…Be the change you want to see in the world…” M.K.Gandhi

Pillai & Warman ©Pfizer, Inc Page: 4

Acknowledgements

• Martin Warman Sr. Manager/Team Leader of Process Analytical Support

Group, Pfizer Global Manufacturing

• Jeff MillerStrategic Sourcing Manager, Pfizer Global Sourcing

Common PAT Software Project Core Team Member

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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

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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 September 2004

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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 to GMPs

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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

• Role based• Event based

Scalable, reliable, flexible, secure and timely information required in Pharmaceutical Manufacturing

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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

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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

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Block diagram PAT measurement

Tank

ATPC

PASHist

Detector

DB

System FunctionsSpectrometer

Configuration

ProcessConfiguration

Data Modelling

MethodData Analysis

•Control spectrometer•Acquire data•Run predictions•Displays prediction•Store data•Maintain calibration, event log etc•Generate methods

•Pre-treat spectral data•Extract constituent data

About 3000 floating point values for 500 samples

PAT is a tool as a part of a system to verify process robustness

Pillai & Warman ©Pfizer, Inc Page: 12

Impacts on Infrastructure/Architecture

CustomersCustomers

R&DInformatio

nMulti-factorial

Analysis

Shared Knowledge Management

Over Product Lifecycle

ProcessUnderstanding

Risk Analysis& Mitigation

JustifyInnovation

ProcessDesign

ContinuousImprovementLab

Analysis

Weigh &

DispenseProcessing PackagingRaw

MaterialsFinal

Product

On-lineMeasurem

ents

ProcessControl

Distribution

©ARC Advisory Group. Used with permission

New requirementsThis requirement poses new challenges to current infrastructure

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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 overcome these challenges.

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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

Pillai & Warman ©Pfizer, Inc Page: 15

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.

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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

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Common PAT SoftwareFunctional Architecture

Instrument and Sensor InterfaceInstrument and Sensor Interface

P R O C E S SP R O C E S S

Sensors/ControlSensors/ControlDevicesDevices

FutureFutureInstInst

Protocol AdapterProtocol Adapter

InstrumentInstrument

InstrumentInstrument

Prop. Inst. SoftwareProp. Inst. Software

Protocol AdapterProtocol Adapter Protocol AdapterProtocol Adapter

Unit Unit OperationOperation

Protocol AdapterProtocol Adapter

TransientTransientPAT DataPAT Data

Protocol AdapterProtocol Adapter

SensorSensor

PAT Common User InterfacePAT Common User Interface

On-lineOn-linePrediction & MonitoringPrediction & Monitoring

PATPATInstrument ControlInstrument Control

Off-lineOff-lineMethod BuilderMethod Builder

Common Data AccessCommon Data Access

Off-lineOff-lineRetrieval, AnalysisRetrieval, Analysis

StorageStorage

ProcessProcessControl Control SystemSystem

Design of ExperimentDesign of Experiment

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PAT Paradigms of Use

PAT Mode: Monitor PAT Mode: Control PAT Mode: Optimize

Process

Analyzer

Interface•Instrument Control

•Data Analysis

Process

Analyzer

Interface

•Instrument Control

•Data Analysis

•Controller Interface

Controller

MethodProcess

Analyzer

Interface

•Instrument Control

•Data Analysis

•Method Builder

•Predictive Modeling

•Controller Interface

Controller

Method Modeller