CONTINUED PROCESS VERIFICATION (CPV) INFORMATICS SYSTEMS AND VALIDATION

Transcription

1 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

2 Outline 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 2

3 1. Background BioPhorum Operations Group (BPOG) BioPhorum BioPhorum Development Group CPV and Informatics Team Industry-wide collaboration on BioPharma drug substance operations Started in 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

4 1. Background BPOG CPV and Informatics Team FDA releases process validation guidance with CPV BPOG CPV team formed BPOG CPV Informatics team formed BPOG CPV case study published BPOG CPV and Informatics teams merged BPOG roadmap for CPV implementation published BPOG responses to signals paper published BPOG legacy products paper due for publication BPOG CPV informatics system paper due for publication 4

5 2. Validation Scope Source Systems User Interaction CPV System Data Preparation and Aggregation Analyses Reports 5

6 3. Data Integrity What is Required Source Systems Data from CPV system must match data from the source systems CPV System Statistical and graphical outputs from CPV system must match data 6

7 3. Data Integrity How to Achieve Effort Fully Automated Cumulative Automated Fully Manual Cumulative Manual Time 7

8 4. Risk-Based Approach Risk Priority = Severity x Probability x Detectability Depends on intended use Depends on system design Depends on system design Risk-based orientation is a guiding principle of the FDA s CGMPs for the 21 st Century Initiative 1 Severity Examples Probability Examples Detectability Examples High OOS batch released High >10% chance Low Very hard to detect Medium GMP document incorrect Medium 1-10% chance Medium Can detect, but takes effort Low Time wasted Low <1% chance High Easily detected 1 Pharmaceutical CGMPs for the 21st century - A Risk-Based Approach 8

9 4. Risk-Based Approach Severity Low Medium High Risk Class High Medium Low Risk Priority = Severity x Probability x Detectability Probability Detectability High Medium Low Method of Transfer Automated Manual Risk Class Source System Type GMP Non-GMP CPV System Procedures Well-designed Non-existent 1 M H H 2 L M H 3 L L M Source Change Notification Priority Automated Manual None Atypical Data Notification Automated Manual None Manual Entry Verification Blinded Visual None 9

10 5. Optimized Testing System Design 1 Create reusable core objects Create configuration libraries Maximize use of master data 3 Core 2 Documentation Leverage from vendor Eliminate redundancy Procedures for routine tasks Testing Leverage from vendor Leverage procedures Align testing to risk priority Risk Priority High Medium Low Level of Testing Positive and negative; Objective evidence or second person verification Positive testing; Clear documentation Minimal testing; Pass/Fail Only 10

11 6. Change Management Why it matters CPV Plan LIMS System Investigation System Software Configurations CPV System Hardware Instruments Batch Records ERP System Control Historian System 11

12 6. Change Management - Awareness 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! 12

13 6. Change Management - Efficiency Reduce documentation Re-use configurations 1 3 Core 2 Recycle impact assessments 13

14 Severity Risk Class Effort 7. Conclusion Validation Scope Data Integrity Probability Time Detectability Risk-Based Approach L M H H M H H M L M H L L L M Risk Class H M L 1 M H H 2 L M H 3 L L M Priority Optimized Testing 3 1 Core 2 Change Management Investigati on System Configurati ons CPV Plan Software CPV System Hardware LIMS System Instrument s Batch Records ERP System Control System Historian 14

15 Questions 15