PDA PTC PUPSIT 2

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PDA PTC PUPSIT 2

2020

Most Recent

Points to Consider for Implementation of Pre-Use Post-Sterilization Integrity Testing (PUPSIT)

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Pre-use/post-sterilization integrity testing (PUPSIT) has been a widely debated topic for the last several years. To a large extent, the debate has been due to the fact that scientific data were not available to provide additional clarity that could inform appropriate risk-based decisions and commensurate actions. To gain clarity on this and other topics related to sterile filtration, PDA and BioPhorum formed the Sterile Filtration Quality Risk Management (SFQRM) consortium in late 2017. The consortium goals are to fill existing gaps in scientific data with studies and industry guidance that would provide professionals and license holders with the ability to make informed decisions about quality risk management strategies.

PDA PTC PUPSIT 2
STANDARD INFO:
Standard NamePDA PTC PUPSIT 2
ScopePoints to Consider for Implementation of Pre-Use Post-Sterilization Integrity Testing (PUPSIT)
PublisherPDA - Parenteral Drug Association
LanguagesEnglish
State
Publication Year2020
Most recent VersionMOST RECENT
Whether to be replaced
Addendum
FILE INFO:
File Size1 file , 4.9 MB
ISBN(s)9781945584183
Number of Pages39
Published03/01/2020
PDA PTC PUPSIT 2
HistoryPublisher Year

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