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OtherCommentary

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{at}gmail.com
Fanzia Mohammed
2 Genentech/Roche
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  • For correspondence: mohammed.fanzia{at}gene.com
Emma Ramnarine
2 Genentech/Roche
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  • For correspondence: eramnar{at}gene.com
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PDA Journal of Pharmaceutical Science and Technology: 79 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 6
November/December 2025
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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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More in this TOC Section

  • NIIMBL-Facilitated Active Listening Meeting between Industry and FDA Identifies Common Challenges for Adoption of Alternative and Rapid Microbiological Methods
  • Considerations for the Validation of Non-CFU Based Bio-Fluorescent Particle Counting Technologies
  • PAT Implementation - Managing the Transition from Traditional Environmental Monitoring to In-Process Control of Aseptically Filled Products.
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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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