The best transfer is no transfer, but sometimes transfers are the only choice
We help our clients to master the two core processes effectively and efficiently: transfer selection and transfer implementation
The transfer selection process encompasses identification of transfer ideas, assessment of transfer candidates and prioritization of transfer proposals always safeguarding the business rationale behind every intended transfer
The implementation of a transfer is usually a multi-disciplinary project … and, in cases of high complexity and size of the affected product portfolio, a program of projects. Core phases of a transfer project / program are:
- Transfer approach and (initial) project planning
- Preparation of transfer master documents
- Technology transfer – e.g. installation and qualification of equipment, the transfer activities for analytical methods, production and packaging according to the transfer protocols and timelines agreed in the project plan
- Provisioning of registration documents – e.g. site accreditation, CPP, export certificates, CMC and non-CMC documents, registration dossier – and registration samples
- Adaptation of the supply chains so that uninterrupted market supply during and after the transfer is guaranteed incl. sizing of safety stock, master data mgmt., artwork management, and smooth integration of new sites
- Transfer closure
- Transfer monitoring
The transfer of a pharmaceutical product is defined as the documented (partial) production shift of a finished product and / or its intermediates from a sending unit to a receiving unit.
Both, the sending unit and the receiving unit can be part of the internal or external network of manufacturing sites.
The transfer includes all relevant changes and measures along the supply chain to enable the product supply from the receiving unit (e.g. material supply, production, quality control, regulatory compliance, GMP compliance, logistics, safety, industrial hygiene and environmental protection).
JSC has many years of experience in the set-up of transfer units and in managing and supporting transfer projects or programs.
Transfer Excellence – right prioritizing of transfer projects and implementing them right