Streamlining Method Transfer Across Global Sites

The European Commission, Health and Consumers Directorate-General guidelines (2) outline that a methodtransfer protocol should include, but not be limited to, identification of the relevant test method(s) and testing to be performed, standards and samples to be tested, special transport and storage...

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Bibliographic Details
Published in:Pharmaceutical technology Europe 2020-09, Vol.32 (9), p.30-39
Main Authors: Barker, Amy R, Pack, Brian W, Sailer, Dawn E, Argentine, Mark D
Format: Article
Language:English
Subjects:
Certification
FDA approval
Laboratories
Test methods
Online Access:Get full text
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Summary:The European Commission, Health and Consumers Directorate-General guidelines (2) outline that a methodtransfer protocol should include, but not be limited to, identification of the relevant test method(s) and testing to be performed, standards and samples to be tested, special transport and storage conditions, and acceptance criteria (2). USP's , which discusses comparative, co-validation, and revalidation approaches to methodtransfer testing, recommends that testing be performed on homogeneous lots of target material (9), while WHO lists possible experimental designs and acceptance criteria for test methods to account for the variability and sensitivity of the method and the specifications for the quality parameter (10). From the authors' experience, and as noted in a position paper on transfer of analytical methods (11), a better overall prediction of consistent longer-term method performance is ensured by testing one or two representative and/or rangechallenging batch(es) with an increased number of testing setups, rather than performing fewer setups with an increased number of batches. [...]the total number of method transfers that may occur within the projected shelf life of the MTK should be considered.
ISSN:1753-7967