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48 views

Ispe Baseline Guide v5 Commissioning and Qualification 2nd Ed 2019 PDF 2 PDF Free 5

Uploaded by

asilveyra
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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ISPE Baseline® Guide: Page 3

Commissioning and Qualification

Acknowledgements
The Guide was produced by a Task Team led by:

Chris Ames Akebia Therapeutics Inc. USA


Nick Haycocks Amgen, Inc. USA
Bob Myers Pfizer Inc. USA
Mark E. Rezac, PE Integrated Project Services, LLC USA
Steven Wisniewski CAI USA

The work was supported by the ISPE Commissioning and Qualification Community of Practice (CoP).

Core Team

The following individuals took lead roles in the preparation of this Guide:

Tiffany Baker ValSource USA


Joerg Block, PhD Bayer AG Germany
Ronald Brunelle Amgen, Inc. USA
Graham Cameron GlaxoSmithKline UK
Peter Werner Christensen Cook Medical Denmark
Hazem Eleskandarani, PE Johnson & Johnson USA
Lori Kim AbbVie USA
Glenn Lawrence Independent Pharm Consultant (Merck & Co. – retired) USA
Xavier Pieri GlaxoSmithKline Vaccines Belgium
Alice Redmond CAI Ireland
Ramon Ruiz Quinones Merck & Co., Inc. USA
Ghenet Simpson GlaxoSmithKline USA
Frank van der Steen FVCS Netherlands
Michelle Whipple Rentschler Biopharma Inc. USA

Regulatory Input and Review

Particular thanks go to the following for their review and comments on this Guide:

Karl-Heinz Menges Regierungspräsidium Darmstadt Germany


Kevin O’Donnell Health Products Regulatory Authority (HPRA) Ireland
This Document is licensed to
Tatiana Oliveira da Silva COVISA Brazil

Special Thanks
Dr. Fearghal Downey
The Leads would like to thank Michelle Gonzalez (Amgen – retired, USA) for her work on the Glossary. The Leads
Cork,
would also like to thank ISPE for technical writing and editing support by Nina Wang (ISPE Guidance Documents
Technical Writer/Editor) and production support by Lynda Goldbach (ISPE Guidance Documents Manager).
ID number: 284828
The Team would like to express their grateful thanks to the many individuals and companies from around the world
who reviewed and provided comments during the preparation of this Guide; although they are too numerous to list
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here, their input is greatly appreciated.

Company affiliations are as of the final draft of the Guide.

Cover photo: courtesy of IPS – Integrated Project Services, LLC, https://ipsdb.com.

For individual use only. © Copyright ISPE 2019. All rights reserved.

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