Industry One-Voice-of-Quality Solutions Management Review of Post-Approval Changes Guide

Anders Vinther; Fanzia Mohammed; Emma Ramnarine

doi:10.5731/pdajpst.2021.012627

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Industry One-Voice-of-Quality Solutions Management Review of Post-Approval Changes Guide

Anders Vinther, Fanzia Mohammed and Emma Ramnarine

PDA Journal of Pharmaceutical Science and Technology September 2021, 75 (5) 454-457; DOI: https://doi.org/10.5731/pdajpst.2021.012627

Anders Vinther

1QBA, San Carlos, CA

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For correspondence: Vinthera64@gmail.com

Fanzia Mohammed

2Quality Systems and Quality Management, Global Quality and Compliance, Genentech/Roche, South San Francisco, CA

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Emma Ramnarine

3Global Head External Development Collaborations, Genentech/Roche, South San Francisco, CA

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vol. 75 no. 5 454-457

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

Published online September 27, 2021.

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previous version (March 15, 2021 - 05:58).
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Author Information

Anders Vinther¹,*,
Fanzia Mohammed² and
Emma Ramnarine³

¹QBA, San Carlos, CA
²Quality Systems and Quality Management, Global Quality and Compliance, Genentech/Roche, South San Francisco, CA
³Global Head External Development Collaborations, Genentech/Roche, South San Francisco, CA

↵*Corresponding Author: QBA, 915 Washington St., San Carlos, CA 94070; E-mail: 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 Solutions Management Review of Post-Approval Changes Guide

Anders Vinther, Fanzia Mohammed, Emma Ramnarine

PDA Journal of Pharmaceutical Science and Technology Sep 2021, 75 (5) 454-457; DOI: 10.5731/pdajpst.2021.012627

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Industry One-Voice-of-Quality Solutions Management Review of Post-Approval Changes Guide

Anders Vinther, Fanzia Mohammed, Emma Ramnarine

PDA Journal of Pharmaceutical Science and Technology Sep 2021, 75 (5) 454-457; DOI: 10.5731/pdajpst.2021.012627

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Keywords

Pharmaceuticals
Post-approval change
PAC
ICH Q10
pharmaceutical quality system
PQS
science and risk-based approach
management review
One-Voice-of-Quality
1VQ
regulatory flexibility

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