The definition of technology transfer (TT) may vary depending on the type of TT. It is generally referred as bridge between academia and industry, though it may also involve transfer of knowledge within the industry. In the pharmaceutical industry, TT would very often include transfer of new product and process from development to manufacturing. It may also include transfer of analytical method from research to testing laboratories.

In general, the TT includes activities undertaken to transfer knowledge generated during research and development to small scale regulated for clinical trials production and/or commercial production and/or regulated testing for product release.

Planning and Designing the Technology Transfer Process

The TT process must be planned appropriately. Its design should commensurate the risk and the stage of the product life cycle. The regulatory authorities would expect each TT to be conducted in accordance with signed agreement and approved procedure(s). The impact and risks associated with the TT should be assessed initially and then evaluated following completion of each stage of the TT to ensure that the implemented risk controls are appropriate and acceptable.

Technology Transfer Regulatory Requirements

As an integral part of the product life management, TT is a subject to regulatory requirements. As such the following requirements should be met by the sending unit (SU) and receiving unit (RU):

clearly defined roles and responsibilities in a formal agreement,
appropriately designed, defined and documented quality management system with implemented quality risk management principles,
approved documentation associated with the TT process (e.g. protocol, SOPs, records, reports etc),
premises and equipment suitable for the intended operations,
completed qualification and validation.

To ensure successful transfer, the SU must ensure that all required information including documentation is available and provided to the RU. The RU on other hand, must ensure that they have the necessary organizational, quality and technical controls to accommodate the intended production or testing capacity in accordance with the regulatory requirements.

Activity Stages of Technolgy Transfer

Each TT comprises of initiation, planning, transfer execution, and review and closeout stage. Activities included in each stage should be defined in appropriate procedure(s) including the type of deliverables expected at each stage.

Initiation Phase

During the initiation phase, the following activities may be included:

defining product/process/test method requirements,
identification and selection of RU,
development of regulatory strategy,
confirmation on sourcing/supply chain function and contact details ,
initial risk assessment.

If the RU is a different company, considerations should also be made regarding any business, regulatory or legal implications, such as intellectual properties rights, conflict of interest, confidentiality agreements, etc.

Planning Stage

The planning stage includes start of the transfer of knowledge and it includes both the SU and the RU. The activities that will occur in this stage include:

development of the TT protocol including deliverables,
transfer of knowledge that may include:
- Documentation – manufacturing batch records, procedures, historical records, engineering drawings, URS, etc.
- Specifications – product CQAs, process CPP, method specifications/limits.
- Risk/Gap assessment(s).
- Premises and equipment requirements.
- Validation reports.
- Sourcing/Supply Chain Map.
- Professional expertise – experts in the relevant areas, trained personnel in use of specific technique(s).
- Health, safety and environmental requirements.
- Material – specifications, reference material, standards, etc.
- Regulatory requirements applicable for the product/process in question in the applicable jurisdiction where the products will be marketed/used.
- Regulatory requirements applicable for the analytical method for the type of product/material to be tested.
review and update risk assessment,
development of documentation for use in the transfer stage (validation protocols, manufacturing batch records,
determination of CPP,
development of in-process testing, sampling and testing strategy,
review and update of regulatory strategy.

Transfer Execution Stage

The transfer execution stage includes execution of the TT protocol in accordance with the approved procedures and batch records as applicable. The execution stage will include execution of the following activities as appropriate:

pilot production/engineering run(s),
PPQ batches,
analytical method validation,
product testing and release,
review and update of risk assessment,
development of TT report.

The execution stage will also include the handover, where the manufacturing process or the analytical testing method is transferred to the team for routine production and/or testing.

Review of the Technology Transfer Process

The review of the TT process and its progress is reviewed during the review and closeout stage. This stage will include activities to ensure at minimum that:

all TT activities have been conducted in accordance with the approved procedures,
collected data are appropriate and acceptable,
any deviations and changes have been assessed and evaluated as appropriate,
any lessons learnt have been implemented in the production and/or testing process appropriately,
new suppliers have been integrated in the quality system as required.

It is recommended, however not essential, for each TT to be managed/coordinated by a TT lead on each site i.e. sending unit (SU) and receiving unit (RU), to ensure that:

TT procedure has been implemented,
progress monitored and communicated to relevant parties,
deliverables for different stages are available,
decisions made and recorded as required in a timely manner.

It is imperative for the TT process to be well documented and supported by relevant data, as this information will provide evidence that the RU can routinely reproduce the transferred product, process or conduct the analytical method procedure.

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The expert consultants at PharmOut can provide guidance and document development to ensure compliance with the regulatory requirements – Contact us to discuss how we can help.