FDA灭菌工艺验证资料指南（英文）.pdfVIP

Guidance for Industry for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products Center for Drug Evaluation and Research (CDER) Center for Veterinary Medicine (CVM) November 1994 CMC 2 TABLE OF CONTENTS I. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .