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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
Pillai & Warman ©Pfizer, Inc Page: 5
Top issues
• Patent expiries• Pressure to reduce drug costs• Challenges to IP • Counterfeiting & Piracy• Unmet needs• Regulatory Pressures
Unprecedented Need For Change
Pillai & Warman ©Pfizer, Inc Page: 6
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
Pillai & Warman ©Pfizer, Inc Page: 7
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
Pillai & Warman ©Pfizer, Inc Page: 8
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
Pillai & Warman ©Pfizer, Inc Page: 9
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
Pillai & Warman ©Pfizer, Inc Page: 10
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
Pillai & Warman ©Pfizer, Inc Page: 11
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
Pillai & Warman ©Pfizer, Inc Page: 13
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.
Pillai & Warman ©Pfizer, Inc Page: 14
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.
Pillai & Warman ©Pfizer, Inc Page: 16
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
Pillai & Warman ©Pfizer, Inc Page: 17
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
Pillai & Warman ©Pfizer, Inc Page: 18
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