The unique nature of many drug products, and the process of going from discover through to commercial manufacturing frequently requires specific, bespoke methods to be developed for quality testing.  At some point, these methods may need to be used by another laboratory, which must be able to demonstrate its proficiency in the method.  Such method transfer or transfer of analytical procedures (TAP) requires specialist expertise.

RSSL have over 20 years’ experience in the transfer of a wide-range of methods for both API and drug products and are experts in the planning and execution of these activities, working with you to devise the most appropriate transfer strategy.  Through careful planning, and a full review of all aspects of the method history (including original development and validation), we are confident that our method transfer process is robust and sure of a successful conclusion. 

The types of transfer strategy employed would be tailored to the specific scenario, but options would include: 

  • Comparative transfer
  • Co-validation
  • Re-validation
  • Determination of suitability of a transfer waiver

 

 

 

 

 

 

 

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