Risk-based analytical method transfer: application to large multi-product transfers.
As pharmaceutical companies adapt their business models, a new approach to analytical method transfer is needed to efficiently handle transfers of multiple products, associated with situations such as site consolidations/closures. Using the principles of risk management, a risk-based method transfer approach is described, which defines appropriate transfer activities based on a risk assessment of the methods and experience of the receiving unit. A key step in the process is detailed knowledge transfer from the transferring unit to the receiving unit. The amount of transfer testing required can be streamlined or eliminated on the basis of a number of factors, including method capability, receiving unit familiarity, and method past performance.
Raska
Christina S
CS
GlaxoSmithKline, P.O. Box 13398, Research Triangle Park, North Carolina 27709, USA. christy.s.raska@gsk.com
Bennett
Tony S
TS
Goodberlet
Scott A
SA
D004345:Drug Industry / Q000379:methods*; D004364:Pharmaceutical Preparations / Q000032:analysis; D012307:Risk Factors; D012308:Risk Management / Q000379:methods*
D004364:Pharmaceutical Preparations