The background is the update of the previous "WHO guidelines on the transfer of technology in pharmaceutical manufacturing" from 2011. The revised document is intended to support inspections regarding COVID-19 therapeutics.
The guideline is to be applied to technology transfer of processes and procedures related to
The guideline applies to all pharmaceutical dosage forms and is also applicable to other products such as biopharmaceuticals, vaccines, medical devices and vector control products.
The following general principles and requirements are to be followed in a technology transfer project:
The document is available for public consultation until February 2021. In October 2021, the final guideline is scheduled to be presented at the 56. meeting of the Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP).