Technology Transfer Regulatory Requirements

The WHO guidelines define technology transfer as a logical procedure that controls the transfer of products, processes, and knowledge, together with their documentation and professional expertise, within a facility or between facilities. It may involve development, manufacturing, and testing sites. The transfer may occur during a product’s development phases or after obtaining marketing authorization.

The WHO guidelines, as well as ICH Q10 and ICH Q12, consider the transfer of technology part of a pharmaceutical product’s lifecycle.

When the transfer is between different companies, in addition to regulatory and quality implications, it may also have legal and economic implications that need to be considered and addressed when planning the technology transfer.

The goal of a Technology Transfer

Depending on the development phase, the goal of the technology transfer is to transfer product and process knowledge between development and manufacturing, between small-scale manufacturing lines to large-scale manufacturing lines, or between manufacturing sites to achieve product realization.

The knowledge transferred forms the basis for establishing the manufacturing process, control strategy, process and methods validation approach, and ongoing continuous improvement.

What does the Technology Transfer project include?

• Documented project plan covering the different aspects of the project, relevant responsibilities, and timelines.
• Detailed description of the process steps and analytical methods.
• Detailed quality risk management plan.
• Comprehensive gap analysis to assess the capabilities of the receiving unit (RU) and the sending unit (SU) in terms of facilities, equipment, QC laboratories, quality, and regulatory aspects. This may be achieved by way of thorough due diligence.

The success of a technology transfer process depends heavily on the communication, transparency, and goodwill of both the SU and the RU.

Comparability between the original process to the transferred process

Whether it is during the development phases or post-approval, a comparability exercise to support the technology transfer should be executed. Based on the project step, the complexity and number of changes will define the extent of comparability to be conducted.  ICH, FDA, and EMA guidelines on comparability should be consulted.

Guidelines about post-approval changes should be considered to understand how to manage the change and the reporting requirements.

Meeting with regulatory authorities prior to initiation of the technology transfer

It is important to consult with the relevant regulatory authorities prior to the initiation of the technology transfer. If it is a product in the development phase with an active IND, ensure you provide the FDA with the technology transfer plans, including the comparability protocol, before engaging in the process. This will allow the FDA to provide you with timely comments. For an approved product, it is even more important and relevant to provide the regulatory authority with your plans for future changes to avoid risking your commercial supply.

Conclusion

Technology transfer of a manufacturing process is a key and complex activity in the pharmaceutical industry. It requires careful planning and execution, as well as consideration of which development stage it is recommended to encompass in such a process. Stakeholders from different expertise should be consulted, and regulatory expectations should be taken into consideration, all to ensure a successful transfer and continuation of product development or commercialization.

List of guidelines:

1. WHO guidelines on transfer of technology in pharmaceutical manufacturing, 2011
2. New Version on WHO Guidelines on Process Transfer, 2021
3. ICH Q10 Pharmaceutical Quality System
4. ICH Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management

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