PRODUCT TRANSFER
Scope
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This scope applies to all Product transfers of marketed :
Active Pharmaceutical Ingredient
Intermediate
Pharmaceutical product
Medical Device
From :
one site to another site within the same company
one site to an external sub-contractor or visa versa
Between two sub-contractors
This scope does not apply to transfers of new products
from Development to commercial manufacturing
Responsibilities
• Operational Sourcing Committee : propose,
review, approve transfers
• Project leader : solution of transfer-related
issues, preparation of transfer protocol,
communication with sites and operational
management
• Site project coordinator : at sending and
receiving sites, focal point for
communication, ensure coordination and
oversight within their site, can be project
leader
Responsibilities
• Cross-functional transfer team
(representatives from involved functions at
sending and receiving sites) : performing
activities associated with transfer :
manufacturing and control processes
• Quality at originating site assess compliance
status of receiving site / feasibility study
• Regulatory at both sites: define regulatory
strategy with Quality
 CMC
Responsibilities
• Regulatory at sending site: assess receiving site is
authorised by Regulatory Authorities for
Manufacture and testing of concerned API or
pharmaceutical form
• Site quality management :
 sending and receiving site review and approve
transfer protocol and report
 Receiving site review and approve validation protocol
• Quality function has final responsibility to accept
or reject transfers
Responsibilities
• Sending site : supply product to
market until final approval from
receiving site : avoid stock-out!
Requirements
• Transfer must ensure maintenance of:
Product quality
Process robustness
Regulatory compliance
Requirements
• Transfer Process Phases
1 - Pre-evaluation
o Originates in company Operational Unit
transfer request form describing the product is
issued
o Regulatory at sending site performs compliance
assessment of product in all markets
2 - Feasibility Study
o Transfer request form
Sending and
Receiving sites determine means and timelines
Requirements
• Feasibility Study outcomes are :
o Definition of objectives and organization
o Appointment of transfer team leader, coordinators
at S & R sites, cross-functional transfer team
o Quality and compliance assessment of receiving
unit : company own site or subcontractor with
audit result. For subcontractor: in case no audit
available
perform GMP audit. If critical
findings : raise CAPA prior to starting operational
transfer phase
• Regulatory evaluation : regulatory strategy
defined (cf. slide 4 for responsibilities)
Requirements
• Feasibility Study outcomes are (cont.) :
 Product stability evaluation assessed by sending site based on postapproval study results
 Technical feasibility evaluation :
» sending site creates transfer dossier with technical details
» existing documents available to receiving site
» receiving site assess technical feasibility : process and
product
» if changes needed : pilot or industrial trials to be performed
and evaluation of impact
» major change required (development/new process)
outside of this scope
» complete study documented
Requirements
• 3 - Transfer Protocol
 Defined and based on feasibility study results
 All activities, associated responsibilities and timelines described
 Stability protocol and Regulatory strategy/actions included
 APIs : protocol must include strategy how to include new
manufacturing site in all dossiers and necessary stability studies
of medicinal products or medical device
 Stability protocol : validation batches with 3 months stability
results assessment before receiving site batches release
o Accelerated conditions or extended post-approval study in
case of stability sensitive product
o Zones III/IV markets : stability study to be considered
o Transportation stability study to be considered
 Protocol reviewed and approved (cf. slide 4)
Requirements
• 4 – Operational Phase
 Responsibility : Receiving Site
 Analytical transfer : before process transfer
 Preparation of Process validation :
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Review of process validation performed in SS by the RS
Quality assessment based on APR or separate risk analysis
Production of pilot or industrial batches at RS
Orders of required materials, components, equipments
• Installation of required qualification of equipments, utilities
and facilities. Any change
change control ; equipment
transferred to be requalified prior to use
• RS Staff trained and documented on all aspects of transfer
process
Requirements
• Preparation of Process validation (cont.)
 New product introduced in cleaning validation plan at RS
• Process validation
 Performed by RS according to validation protocol
 Manufacture 3 consecutive batches at least
 Representative of SS can be requested
 Validation performed when all validation protocol requirements
are met and RS quality management approves report
• Regulatory Activities
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prepares documents for variations
Review and submission : same process as usual
In case Pre-AI, submission after review and approval by Quality
Other submissions after review and approval by Site Quality Head
Requirements
• 5 – Finalisation of Product Transfer
Product Leader
o compiles all results in report
o Assesses the overall success of transfer
In-case of development report : included in
transfer report
SS and RS Quality Heads review and approve
product transfer report
Regulatory approvals must be obtained before
project is considered completed
Requirements
• 6 – Batch Release
Batches released to market
o Approval from Regulatory Authorities obtained
o Validation successfully executed and reported
o All products specifications are met including
stability data
Release decision : RS Quality Head
Thank You
Any Questions