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Related Experiment Videos

Risk-based analytical method transfer: application to large multi-product transfers.

Christina S Raska1, Tony S Bennett, Scott A Goodberlet

  • 1GlaxoSmithKline, P.O. Box 13398, Research Triangle Park, North Carolina 27709, USA. christy.s.raska@gsk.com

Analytical Chemistry
|June 19, 2010
PubMed
Summary
This summary is machine-generated.

A risk-based approach streamlines analytical method transfer for pharmaceutical companies facing business model changes. This method optimizes testing by assessing risks and leveraging the receiving unit's experience.

Related Experiment Videos

Area of Science:

  • Pharmaceutical analysis
  • Quality control in drug manufacturing

Background:

  • Pharmaceutical companies face evolving business models, necessitating efficient analytical method transfer.
  • Site consolidations and closures require adaptable strategies for managing multiple product transfers.

Purpose of the Study:

  • To describe a novel risk-based approach for analytical method transfer.
  • To enhance efficiency in handling multiple product transfers during business model adaptations.

Main Methods:

  • Application of risk management principles to method transfer.
  • Conducting a risk assessment of analytical methods and receiving unit expertise.
  • Implementing detailed knowledge transfer between transferring and receiving units.

Main Results:

  • Defined appropriate transfer activities based on risk assessment.
  • Streamlined or eliminated transfer testing based on method capability, unit familiarity, and past performance.
  • Facilitated efficient handling of multiple product transfers.

Conclusions:

  • A risk-based method transfer approach is effective for modern pharmaceutical business needs.
  • Knowledge transfer is crucial for successful and efficient method implementation.
  • Optimized transfer testing reduces resource burden while maintaining quality.