Transfer Validation Requirements By Site Transfer Morning
Session #3 Robert Beall, PMP
Slide 2
Introduction 2Confidential Robert Beall 2 Transfer Experience
Solids Transfer Engineer for Optimization in North America (OPINA)
132 Product transfers Managed Europe to USA NDA product transfers
for 3 blockbuster product lines. Head of International transfers
between Germany, US and India for WW distribution 18 products Head
of Life-Cycle product transfer for parenteral manufacturing 64
products. Solids Transfer Manager for animal Healthcare products 32
products Medical Device Transfer Consultant 4 products Biological
product transfer leader 4 products Hometown: Syracuse, NY Home:
Providence, RI Family: Gnther (Son), Maren (Daughter), Calvin (Son)
Hobbies: Sailing, Travel, Olympic Weightlifting Education: RIT BS -
Engineering PMP
Slide 3
Agenda 3Confidential Lifecycle Validation Requirements by
transfer type: 1)Definitions 2)Stage 1 Development Site to Site
Site to CMO CMO to CMO 3) Stage 2 - Validation Site to Site Site to
CMO CMO to CMO 4) Stage 3 Lifecycle Site to Site Site to CMO CMO to
CMO 3
Slide 4
Definitions 4Confidential Lifecycle Validation Requirements by
transfer type: 1)CMO Contract Manufacturing Organization 2)Site to
Site The Market Autherization Holder (MAH) transfering production
to another site operated by the MAH. 3) Site to CMO The Market
Autherization Holder (MAH) transfering production to a CMO. 4) CMO
to CMO The Market Autherization holder transferrring production
from one CMO to another CMO 5) NA, Normal, Minor, Major Not
applicable, Normal -standard procedure, Minor Reduced, Major
Additional resource utilization required. 4
Slide 5
Lifecycle Validation Requirements 5Confidential 5 Stage 1
Development
Slide 6
Lifecycle Validation Requirements 6Confidential 6 Stage 1
Development Preliminary Documents RequirementMAH to MAHMAH to
CMOCMO to CMO Confidentiality AgreementNANormal Capacity
AssessmentMinorNormal Quality AgreementMinorNormalMajor Development
AgreementNAMajor Transfer AgreementMinorNormalMajor Transfer
PlanMinorNormalMajor Change Management (Q12)MinorNormalMajor
Communication PlanMinorNormalMajor
Slide 7
Lifecycle Validation Requirements 7Confidential 7 Stage 1
Development RequirementMAH to MAHMAH to CMOCMO to CMO Risk
MethodologyNAMajor Quality Target ProfileNormal Major QbD +
Historical DataNormalMajor Process Flow DiagramNormal Major Risk
Priority NumbersNANormal Control StrategyNormal Development
DatabaseNormal Major Item Code GenerationNormalMajor
Slide 8
Lifecycle Validation Requirements 8Confidential 8 Stage 1
Development RequirementMAH to MAHMAH to CMOCMO to CMO Analytical
MethodsMinorNormalMajor Analytical VariationMinorNormalMajor
Analytical Variation in CPPs MinorNormalMajor PVMP outlineNANormal
Statistical Analysis PlanNANormalMajor RPN Reduction
StrategyNANormalMajor Summary ReportMinorNormal
Slide 9
Lifecycle Validation Requirements 9Confidential 9 Stage 2
Process Qualification
Slide 10
Lifecycle Validation Requirements 10Confidential 10 Stage 2
Process Qualification Preliminary Documents RequirementMAH to
MAHMAH to CMOCMO to CMO Confidentiality AgreementNANormal Quality
AgreementMinorNormalMajor Qualification AgreementNAMajor Transfer
AgreementMinorNormalMajor Transfer PlanMinorNormalMajor Change
Management (Q12)MinorNormalMajor Communication
PlanMinorNormalMajor
Slide 11
Lifecycle Validation Requirements 11Confidential 11 Stage 2
Process Qualification RequirementMAH to MAHMAH to CMOCMO to CMO
Stage 1 Summary Report Facility, Utility AssessmentNANormalMajor
Equipment AssessmentNormalMajor Materials Qualification
Qualification Methodology Statistical Terms and formulas Rationale
for Acceptance Rationale for number of batches
Slide 12
Lifecycle Validation Requirements 12Confidential 12 Stage 2
Process Qualification RequirementMAH to MAHMAH to CMOCMO to CMO
Sampling Plan for RPN>100Normal Agreement on Control
chartsNormal Major Acceptance Criteria CPK, PPKNormalMajor Training
on when to adjustMinorMajor Related SOPsMinorNormalMajor Batch
Record ReviewMinorNormalMajor CPP/ CQA Matrix ReviewNormal Major
Risk EvaluationNormal Stage 2 Summary ReportNormal
ArtworkNormalMajor
Lifecycle Validation Requirements 14Confidential 14 Stage 3
Continued Process Verification RequirementMAH to MAHMAH to CMOCMO
to CMO Confidentiality AgreementNANormal Quality
AgreementMinorNormalMajor Supply AgreementNAMajor Transfer
AgreementMinorNormalMajor Transfer PlanMinorNormalMajor Change
Management (Q12)MinorNormalMajor Communication
PlanMinorNormalMajor
Slide 15
Lifecycle Validation Requirements 15Confidential 15 Stage 3
Continued Process Verification RequirementMAH to MAHMAH to CMOCMO
to CMO Stage 2 Summary ReportNormal Revised Batch RecordsNormal
Monitoring AgreementNAMajor Release, Acceptance agreement NAMajor
RPN Reduction AgreementNANormalMajor Process MonitoringNANormal OOT
/ OOS AgreementNANormal Metrics AgreementNANormal
