1 The following outlines what is included within each GMP package:1. GMP Material Selection & Design Package: Single-Use Diagrams, Drawing Approval, Process Design, Supplier and Raw Material Selection, Standardization, and Naming Convention.2. GMP Qualification Package: SU Program Review, Risk Assessment, Documentation Request, Quality Alignment, Risk Mitigation, Approval Package, and Extractables & Leachables (E&L).3. GMP Release Package: SU Library Build, Material File Generation, Material Specification Generation, ERP Master Data, Supply Chain Mapping, and Change Controls.2 The duration slider does not change total hours - it only adjusts how many SMEs are needed to complete the work within the desired time frame.
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