Lyophilization of Parenteral (7/93) by the Food and Drug Administration

ID: lyophilization-of-parenteral-7-93-by-the-food-and-drug-administration

Historical FDA inspection guide dated7/93. Introduction and Glossary distinguish freezing, primary drying by sublimation, and secondary drying by desorption. Cited for phase-change definitions and process-stage terminology. The dated guide is not a statement of current regulatory requirements.

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