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WHO Guideline on Technology Transfer in Pharmaceutical Manufacturing

Technology transfer is the movement of data, designs, inventions, materials, software, technical knowledge or trade secrets from one organisation to another or from one purpose to another.

The technology transfer process is guided by the policies, procedures and values of each organisation involved in the process.

Also known as transfer of technology (ToT), technology transfer ensures that scientific and technological developments are available to a wider range of users who can then help develop or exploit it.

This transfer can occur horizontally across different areas or vertically.

In this case, Technology transfer is the process by which the manufacturing process and analytical method are transferred from one manufacturing unit to another unit or from R&D to manufacturing unit.

Technology transfer from R&D to manufacturing site is critical because of the scale up of the product from pilot batch to large-scale commercial batch. 

A typical technology transfer process can be divided into production part, quality control part and documentation part.

Throughout lifecycle stages, transfers should be appropriate and proportionate to the phase of the product life cycle in order to ensure that product knowledge is maintained and that processes are appropriately controlled. 

The guideline should be applied when transferring the technology of manufacturing processes and analytical procedures relating to active pharmaceutical ingredients (APIs), isolated API intermediates, bulk drug products and finished pharmaceutical products (FPPs). 

While medical devices, as part of the finished pharmaceutical product of a combination medicinal product, would be considered under this guidance, the specific regulatory and quality requirements for medical device manufacturing are covered under separate medical device regulations and quality management systems.

The document addresses the following principal areas:

  • Organization and management of the transfer;
  • Transfer of relevant information in production, including but not limited to processing,
  • Packaging and analytical procedures;
  • Documentation, premises and equipment;
  • Personnel qualification and training;
  • Quality management and risk management;
  • Change management and life cycle approach;
  • Control strategy; and
  • Qualification and validation.

The technology transfer project should fulfil the following general principles and requirements. 

There should be:

  • a documented project plan covering the relevant aspects of the project;
  • a detailed quality risk management plan;
  • a comprehensive gap analysis, including due diligence performed covering technical, quality and regulatory aspects;
  • similar capabilities between the SU (sender unit) and RU (receiver unit), including but not limited to, facilities and equipment where appropriate;
  • knowledge of the differences in process ability between the SU and RU, including the impact, risk and control strategies to overcome any differences;
  • an adequate number of adequately trained personnel with suitable qualifications and experience;
  • effective process and product knowledge management; and 
  • effective communication and transparency between the SU and RU.

Reference: INTERIM VERSION 2021, WHO Guideline

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