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Bridging the Gap: Quality by Design as a Catalyst for Enhanced Quality Management Systems in Biopharmaceutical

Shivang Saxena1, Shubhi Saxena2, Diksha2

  • 1Department of Regulatory Affairs, ISF College of Pharmacy, Moga, Punjab, 142001, India.

Current Drug Discovery Technologies
|October 1, 2024
PubMed

Keywords:
FDA and EMA guidelinesQuality management system (QMS)biopharmaceuticalsquality by design (QbD)regulatory framework.six sigma

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