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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@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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PDA Journal of Pharmaceutical Science and Technology: 77 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 77, Issue 5
September/October 2023
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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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