News about GMP/cGMP

21.12.2020

WHO: Draft guideline on technology transfer in pharmaceutical manufacturing

Shortly before the end of the year, WHO published a 38-page draft with twelve chapters and two appedices on technology transfer in pharmaceutical manufacturing.

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 

  • Active pharmaceutical ingredients (APIs), in-process bulk materials, and finished drug products
  • Process validation 
  • Development and validation of purification processes and  
  • Analytical procedures   

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:

  • A documented project plan covering the relevant aspects of the project  
  • A detailed risk management plan
  • A comprehensive technical gap analysis, including due diligence covering technical and regulatory aspects
  • Similar capabilities between the sending unit (SU) and the receiving unit (RU), including but not limited to facilities and equipment
  • An adequate number of adequately trained personnel with appropriate qualifications and experience
  • And effective process and product knowledge management.

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). 


Source: WHO guidelines on the transfer of technology in  pharmaceutical  manufacturing    



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