PDA TR60 Process Validation A Lifecycle Approach 2026

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3.0 一如既往 2026-03-19 0 12.64MB 162 页 80质量币
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Technical Report
Process Validation:
©PDA 2026
A Lifecycle Approach
No. 60
Revised 2026
Technical Report No. 60 (Revised 2026) ©2026Parenteral Drug Association, Inc.
Technical Report
No.
i
60
Process Validation:
ALifecycle Approach
Revised 2026
ISBN: 978-1-945584-61-9
© 2026Parenteral Drug Association, Inc.
All rights reserved
Technical Report No. 60 (Revised 2026) ©2026Parenteral Drug Association, Inc.
ii
Authors
Co-Leads
Robert F. Dream
HDR Company, LLC
Mauro Giusti
Eli Lilly & Co.
Igor Gorsky
ValSource, Inc.
Christophe Agut
Sanofi
Ajay Babu Pazhayattil, PhD
Itaan Pharma, Inc.
Raphael Bar, PhD
BR Consulting
Agnes Hardy-Boyer, PhD
Sanofi
Christoph Herwig, PhD
Körber Pharma Austria
Marzena Ingram
ELIQUENT Life Sciences
Aditya Khadilkar
Viatris
Mike Long, PhD
AstraZeneca
Toni Manzano
Aizon
Patrizia Muscas
Eli Lilly & Co.
Darius Pillsbury
ValSource, Inc.
Vimal Sachdeva
World Health Organization
Swagat Sangamnerkar
Renaissance Lakewood, LLC
Humberto Vega-Mercado, PhD
BMS
摘要:

pda.orgTechnicalReportProcessValidation:©PDA2026ALifecycleApproachNo.60Revised2026TechnicalReportNo.60(Revised2026)©2026ParenteralDrugAssociation,Inc.TechnicalReportNo.i60ProcessValidation:ALifecycleApproachRevised2026ISBN:978-1-945584-61-9©2026ParenteralDrugAssociation,Inc.AllrightsreservedTechnica...

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作者:一如既往 分类:专业资料 价格:80质量币 属性:162 页 大小:12.64MB 格式:PDF 时间:2026-03-19
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