CONTINUED PROCESS VERIFICATION (CPV) INFORMATICS SYSTEMS ... · PDF fileCPV Informatics...
Transcript of CONTINUED PROCESS VERIFICATION (CPV) INFORMATICS SYSTEMS ... · PDF fileCPV Informatics...
© Biophorum Operations Group Ltd
CONTINUED PROCESS VERIFICATION (CPV) INFORMATICS SYSTEMS AND VALIDATION
OUTPUT FROM BIOPHORUM OPERATIONS GROUP (BPOG) COLLABORATION OF BIOTECH COMPANIES
Carly Cox, Process Informatics Manager, Pfizer
on behalf of BPOG CPV Team
© Biophorum Operations Group Ltd
Outline – CPV Informatics Systems and Validation
1. Background on BPOG and CPV/I Team
2. Validation Scope
3. Data Integrity
4. Risk-Based Approach
5. Optimized Testing
6. Change Management
7. Conclusions
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1. Background
BioPhorum Operations Group (BPOG)
Industry-wide collaboration on BioPharma drug substance operations• Started in 2008
• 29 member companies, over 1000 participants
• Networking and best practice sharing
• Regular teleconferences/web meetings and periodic face-to-face meetings
Established industry best practices on a wide range of quality, engineering and organizational topics considered central to the challenge of mastering effective biotech drug substance operations
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BioPhorum
BioPhorum
Development Group
CPV and
Informatics
Team
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1. Background
BPOG CPV and Informatics Team
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•BPOG legacy products paper due for publication
•BPOG CPV informatics system paper due for publication
2017
•BPOG responses to signals paper published
2016
•BPOG roadmap for CPV implementation published
2015
•BPOG CPV case study published
•BPOG CPV and Informatics teams merged
2014
•BPOG CPV Informatics team formed
2013
•BPOG CPV team formed
2012
•FDA releases process validation guidance with CPV
2011
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2. Validation Scope
Data Preparation and Aggregation
Source Systems
AnalysesCPV System
Reports
User Interaction
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3. Data Integrity – What is Required
Source Systems
CPV System
Data from CPV system must match data from the source systems
Statistical and graphical outputs from CPV system must match data
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3. Data Integrity – How to Achieve
Effo
rt
Time
Fully Automated Fully Manual
Cumulative Automated Cumulative Manual
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“Risk-based orientation” is a “guiding principle” of the FDA’s CGMPs for the 21st Century Initiative1
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4. Risk-Based Approach
1 Pharmaceutical CGMPs for the 21st century - A Risk-Based Approach
Risk Priority = Severity x Probability x Detectability
Depends on intended use
Depends on system design
Depends on system design
Severity Examples
High OOS batch released
Medium GMP document incorrect
Low Time wasted
Probability Examples
High >10% chance
Medium 1-10% chance
Low <1% chance
Detectability Examples
Low Very hard to detect
Medium Can detect, but takes effort
High Easily detected
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4. Risk-Based Approach
Probability
Low
Med
ium
Hig
h
Seve
rity High 2 1 1
Risk C
lass
Medium 3 2 1
Low 3 3 2
Detectability
Hig
h
Med
ium
Low
Ris
k C
lass 1 M H H P
riority
2 L M H
3 L L M
Risk Priority = Severity x Probability x Detectability
Automated Manual
Method of Transfer
GMP Non-GMP
Source System Type
Well-designed Non-existent
CPV System Procedures
Blinded None
Manual Entry Verification
Visual
Automated None
Source Change Notification
Manual
Automated None
Atypical Data Notification
Manual
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System Design
• Create reusable core objects
• Create configuration libraries
• Maximize use of master data
Documentation
• Leverage from vendor
• Eliminate redundancy
• Procedures for routine tasks
Testing
• Leverage from vendor
• Leverage procedures
• Align testing to risk priority
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5. Optimized Testing
Risk Priority Level of Testing
High Positive and negative; Objective evidence or second person verification
Medium Positive testing; Clear documentation
Low Minimal testing; Pass/Fail Only
Core
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6. Change Management – Why it matters
CPV System
Hardware
SoftwareConfigurations
CPV Plan
LIMS System
Instruments
Batch Records
Control SystemHistorian
ERP System
Investigation System
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Proactive notifications
• Change controls
• Master data change requests
• Document revisions
• Investigations
Automated reactive notifications
• Master data comparisons
• Duplicate data checks
• Missing data checks
AVOID MANUAL REACTIVE NOTIFICATIONS!
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6. Change Management - Awareness
=?
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Reduce documentation
Re-use configurations
Recycle impact assessments
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6. Change Management - Efficiency
Core
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7. Conclusion
Validation Scope
Data Integrity
Risk-Based Approach
Optimized Testing
Change Management
Effo
rt
Time
Probability
L M H
Seve
rity
H M H H Risk C
lassM L M H
L L L M
Core
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Copy 2
Copy 3
Detectability
H M L
Ris
k C
lass
1 M H H Prio
rity
2 L M H
3 L L M
CPV System
Hardware
SoftwareConfigurations
CPV Plan
LIMS System
Instruments
Batch Records
Control SystemHistorian
ERP System
Investigation System