Recommended Best Practices for Lyophilization Validation 2021 Part II: Process Qualification and Continued Process VerificationRecommended Best Practices for Lyophilization Validation 2021 Part II: Process Qualification and Continued Process Verification
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This work describes the lyophilization course of validation and consists of two elements. Half one (Half I: Course of Design and Modeling) focuses on the method design and is described