Major Documents for Technology Transfer in Pharmaceutical Industry

Technology Transfer Protocol

An authorized technology transfer document, such as a Master Plan (or Technology Transfer Protocol), should list the intended sequential phases and activities of the transfer, where appropriate. The document should include, for example, the following:

  • title;
  • objective;
  • scope;
  • names and addresses of the SU and RU;
  • technology transfer team including key personnel and their responsibilities from SU and RU;
  • phases of the project including key activities, deliverables and the associated accountabilities;
  • approximate timing of key activities/deliverables including the timing of trial production batches and validation batches;
  • reference to other transfer plan documents relevant to the process being transferred;
  • reference to validation master plans relevant to the process being transferred: equipment/facilities/utilities qualification project plan, site-independent/site525 dependent process validation master plan(s), method validation master plan;
  • reference to gap analysis and risk assessments;
  • acceptance criteria for a successful transfer; and
  • a parallel comparison of premises, equipment, instruments, materials, procedures, and methods for the transfer under consideration.

Standard Operating Procedures (SOP)

Standard operating procedures (SOPs) should be followed describing the actions to be taken during the technology transfer process.

Technology Transfer Report

The report content should reflect the protocol and SOPs that were followed. The report should summarize the scope of the transfer, the critical parameters as obtained in the SU and RU and the final conclusions of the transfer. Changes, deviations, investigations and the relevant appropriate actions taken should be recorded. The SU should provide all the relevant supportive documents with data, results and other relevant information in order to facilitate a successful technology transfer.

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Reference: WHO Guidelines on Technology Transfer in Pharmaceutical Manufacturing

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