Methodology

QbD has developed a framework for tech transfers based on best practices and templates. This tech transfer methodology splits the transfer process into four different phases, and QbD offers advice, consultancy and support with implementation for every single phase. Our tech transfer strategy is based on a risk-based approach to increase the chances of success and improve efficiency.

Phase 1. Duties and responsibilities

Phase 1 deals with project preparation. It focuses on two aspects. First, the legal aspect that involves agreement between parties on license rights and secrecy rules. Second the organisational aspect that involves the set-up of a project team, appointing a team leader, setting out duties and responsibilities and determining the timescale of the project.

Phase 2. Data exchange

In phase 2, all parties determine which information relating to specifications, IPC testing, raw materials and the production process they will exchange. Not a simple exercise, because making assumptions can lead to major misunderstandings. QbD offers a tech transfer checklist covering all of the available information, to set out the expectations of both parties clearly. We also help to determine which information is relevant and offer templates to establish exactly where all the information is located.

Phase 3. Testing and process validation

This phase is the most time consuming phase of the tech transfer methodology. The receiving party analyses the process outlined by the sending party, aligns it with its own standard operating procedures and equipment, and validates it. Process validation is of great importance for the life sciences, healthcare and cosmetics industries. It provides proof that products are of consistent quality. Our validation experts are happy to help you validate all the required processes.

Phase 4. Registration dossier and lessons learnt

During the last phase, all the necessary information is assembled in the correct format ready for the registration dossier. This phase often runs parallel with phase 3. All parties will sit down to write a tech transfer report jointly, to describe deviations from the original scope and lessons learnt. The QbD tech transfer checklist includes the various points of interest during this phase, and offers advice on the registration dossier. The lessons learnt of phase 4 will assist with the continuous improvement of the transfer process.

More information?

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