1. PRODUCT TRANSFER

2. Scope 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

3. 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

4. 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

5. 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

6. Responsibilities
Sending site : supply product to market until final approval from receiving site : avoid stock-out!

7. Requirements Transfer must ensure maintenance of: Product quality
Process robustness
Regulatory compliance

8. Requirements Transfer Process Phases 1 - Pre-evaluation
Originates in company Operational Unit transfer request form describing the product is issued
Regulatory at sending site performs compliance assessment of product in all markets
2 - Feasibility Study
Transfer request form Sending and Receiving sites determine means and timelines

9. Requirements Feasibility Study outcomes are :
Definition of objectives and organization
Appointment of transfer team leader, coordinators at S & R sites, cross-functional transfer team
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)

10. Requirements Feasibility Study outcomes are (cont.) :
Product stability evaluation assessed by sending site based on post-approval 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

11. 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
Accelerated conditions or extended post-approval study in case of stability sensitive product
Zones III/IV markets : stability study to be considered
Transportation stability study to be considered
Protocol reviewed and approved (cf. slide 4)

12. Requirements 4 – Operational Phase
Responsibility : Receiving Site
Analytical transfer : before process transfer
Preparation of Process validation :
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

13. 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
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

14. Requirements 5 – Finalisation of Product Transfer Product Leader
compiles all results in report
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

15. Requirements 6 – Batch Release Batches released to market
Approval from Regulatory Authorities obtained
Validation successfully executed and reported
All products specifications are met including stability data
Release decision : RS Quality Head

16. Thank You
Any Questions