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[한글판70호] Pharmaceutical Engineering 2022년 3-4월호_Volume42, Number 2
2022-05-25 by ISPE Korea
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[한글판70호] Pharmaceutical Engineering 2022년 3-4월호_Volume42, Number2
GAMP® CONSIDERATIONS
When Relying on Open-Source Software
By James Canterbury and Petch Ashida Druar
QUALITY AGREEMENTS FOR SAAS SOLUTIONS Intended for GxP Use
By Michael Zwetkow, Kevin Wm. Roberson, and
Gianna De Rubertis, ing
SUPPLIER QUALIFICATION PROGRAM for Key Raw Materials
By Elizabeth Rivera
(ASEPTIC)
VALIDATION OF ASEPTIC PROCESSES Using Media Fill
By Richard Chai and David J. W. Barber, Cbiol,
MRSB, PCQI
(COMMISSIONING, QUALIFICATION, AND VALIDATION)
LESSONS LEARNED in Global CQV
By Grainne Ryan and Paul Ryan