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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Published in:Pharmaceutical Technology 2017-04, Vol.41 (4), p.38
Main Authors: O'Connor, Kieran, Hulme, Nicola, Shi, Yueer
Format: Magazinearticle
Language:English
Subjects:
Case studies
Chromatography
Innovations
Knowledge
Laboratories
Manufacturing
Methods
Pharmaceutical industry
Pharmaceutical research
Product development
R&D
Reproducibility
Research & development
Technology transfer
Testing laboratories
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Hulme, Nicola
Shi, Yueer
description 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.
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source EBSCOhost Business Source Ultimate; ABI/INFORM Collection
subjects Case studies
Chromatography
Innovations
Knowledge
Laboratories
Manufacturing
Methods
Pharmaceutical industry
Pharmaceutical research
Product development
R&D
Reproducibility
Research & development
Technology transfer
Testing laboratories
title Covalidation strategies to accelerate analytical method transfer for breakthrough therapies
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