CONTINUED PROCESS VERIFICATION (CPV) INFORMATICS SYSTEMS ... · PDF fileCPV Informatics Systems and Validation 4 •BPOG legacy products paper due for publication •BPOG CPV 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


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

228-Oct-2015

CPV Informatics Systems and Validation


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

3

BioPhorum

BioPhorum

Development Group

CPV and

Informatics

Team

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1. Background

BPOG CPV and Informatics Team

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4

•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

© Biophorum Operations Group Ltd28-Oct-2015


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2. Validation Scope

Data Preparation and Aggregation

Source Systems

AnalysesCPV System

Reports

User Interaction



6

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



7

3. Data Integrity – How to Achieve

Effo

rt

Time

Fully Automated Fully Manual

Cumulative Automated Cumulative Manual


“Risk-based orientation” is a “guiding principle” of the FDA’s CGMPs for the 21st Century Initiative1

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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

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/Manufacturing/QuestionsandAnswersonCurrentGoodManufacturingPracticescGMPforDrugs/UCM176374.pdf



9


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


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

Copy 1

Copy 2

Copy 3



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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


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

=?


Reduce documentation

Re-use configurations

Recycle impact assessments

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6. Change Management - Efficiency

Core

Copy 1

Copy 2

Copy 3



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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

Copy 1

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


Questions

28-Oct-2015


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CONTINUED PROCESS VERIFICATION (CPV) INFORMATICS SYSTEMS ... · PDF fileCPV Informatics Systems and Validation 4 •BPOG legacy products paper due for publication •BPOG CPV informatics

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