Covalidation strategies to accelerate analytical method transfer for breakthrough therapies

According to USP , "the transferring unit can involve the receiving unit in an interlaboratory covalidation, including them as a part of the validation team, and thereby obtaining data for the assessment of reproducibility" (3). [...]covalidation is the preferred mode of analytical technol...

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Veröffentlicht in:Pharmaceutical Technology 2017-04, Vol.41 (4), p.38
Hauptverfasser: O'Connor, Kieran, Hulme, Nicola, Shi, Yueer
Format: Magazinearticle
Sprache:eng
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Zusammenfassung:According to USP , "the transferring unit can involve the receiving unit in an interlaboratory covalidation, including them as a part of the validation team, and thereby obtaining data for the assessment of reproducibility" (3). [...]covalidation is the preferred mode of analytical technology transfer within BMS where early identification and engagement of the receiving site is required.
ISSN:1543-2521
2150-7376