Industry One-Voice-Of-Quality (1VQ) Solutions Management Review (MR) of Post Approval Changes (PAC) Guide

Anders Vinther; Fanzia Mohammed; Emma Ramnarine

doi:10.5731/pdajpst.2021.012627

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Industry One-Voice-Of-Quality (1VQ) Solutions Management Review (MR) of Post Approval Changes (PAC) Guide

Anders Vinther, Fanzia Mohammed and Emma Ramnarine

PDA Journal of Pharmaceutical Science and Technology March 2021, pdajpst.2021.012627; DOI: https://doi.org/10.5731/pdajpst.2021.012627

Anders Vinther

1 QBA;

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For correspondence: vinthera64@gmail.com

Fanzia Mohammed

2 Genentech/Roche

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For correspondence: mohammed.fanzia@gene.com

Emma Ramnarine

2 Genentech/Roche

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For correspondence: eramnar@gene.com

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pdajpst.2021.012627

DOI

https://doi.org/10.5731/pdajpst.2021.012627

PubMed

33723006

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Received January 18, 2021
Accepted March 3, 2021
Published online March 15, 2021.

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Anders Vinther1,3 (vinthera64{at}gmail.com),
Fanzia Mohammed2 (mohammed.fanzia{at}gene.com) and
Emma Ramnarine2 (eramnar{at}gene.com)

¹ QBA;
² Genentech/Roche

↵* Corresponding author; email: vinthera64{at}gmail.com

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Approaches to Design an Efficient, Predictable Global Post-approval Change Management System that Facilitates Continual Improvement and Drug Product Availability

Anders Vinther, Emma Ramnarine, Thierry Gastineau, Laura O’Brien, Oliver Brehm, David Fryrear

Therapeutic Innovation & Regulatory Science 2024 58 3

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Industry One-Voice-Of-Quality (1VQ) Solutions Management Review (MR) of Post Approval Changes (PAC) Guide

Anders Vinther, Fanzia Mohammed, Emma Ramnarine

PDA Journal of Pharmaceutical Science and Technology Mar 2021, pdajpst.2021.012627; DOI: 10.5731/pdajpst.2021.012627

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Industry One-Voice-Of-Quality (1VQ) Solutions Management Review (MR) of Post Approval Changes (PAC) Guide

Anders Vinther, Fanzia Mohammed, Emma Ramnarine

PDA Journal of Pharmaceutical Science and Technology Mar 2021, pdajpst.2021.012627; DOI: 10.5731/pdajpst.2021.012627

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Keywords

ICH Q10
management review
One Voice of Quality
pharmaceutical quality system
Post approval change
regulatory flexibility

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