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Article CommentaryCommentary

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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Article Information

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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© PDA, Inc. 2021

Author Information

  1. Anders Vinther1,*,
  2. Fanzia Mohammed2 and
  3. Emma Ramnarine3
  1. 1QBA, San Carlos, CA
  2. 2Quality Systems and Quality Management, Global Quality and Compliance, Genentech/Roche, South San Francisco, CA
  3. 3Global Head External Development Collaborations, Genentech/Roche, South San Francisco, CA
  1. ↵*Corresponding Author: QBA, 915 Washington St., San Carlos, CA 94070; E-mail: Vinthera64@gmail.com
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This article has been cited by the following articles in journals that are participating in Crossref Cited-by Linking.

  • 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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PDA Journal of Pharmaceutical Science and Technology: 75 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 75, Issue 5
September/October 2021
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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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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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