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[한글판59호] Pharmaceutical Engineering 2020년 5-6월호 / Volume40, Number 3

2021-03-29 by ISPE Korea

 

[한글판59호] Pharmaceutical Engineering 2020년 5-6월호 / Volume40, Number 3

INTRODUCCING ICH Q12: A Transformational Product Life-Cycle Management Guideline 

By Eli Zavialov, PhD, Albert V. Thomas, PhD, Saroj Ramdas, Terrance W. Ocheltree, PhD, PRh, and Connie Langer

 

ISPE COMMENTS: to the Annex 2 PIC/S Draft Revision 

By Jean-Francois Duliers

 

UPDATE FROM THE: ISPE Regulatory steering Council 

By Roger Nosal and Sarah Pope Miksinski, PhD

 

2019 ISPE Global Pharmaceutical Regulatory summit REGULATORS ADDRESS INNOVATIONS AND HARMONIZATION 

By susan Sandler

 

A GAMP® APPROACH: to Robotic Process Automation 

By Sion Wyn and James Canterbury

 

GOOD ENGINEERING PRACTICE: in Risk-Based Commissioning and Qualification 

By Chip Bennett, PMP

 

 SOLUBILITY ENHANCEMENT OF IBUPROFEN: by Porous Solid Dispersion Using a Flash Evaporation Method 

By Shmmon Ahmad, Anil Kumar, Abdul Hafeez, PhD, and Rupinder Kaur, PhD

 

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