Process Validation for Lyophilized Drug Products: Comparing a Program for Continued Process Verification in Different Lyophilized Products: Poster Presented at PDA Week 2025
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The 2011 FDA Guidance for Industry, "Process Validation: General Principles and Practices," emphasizes maintaining control of manufacturing processes throughout the product lifecycle through constant reevaluation. For lyophilized drug products, Critical Qual... ...
