fda灭菌工艺验证申报资料指南(中英文).pdfVIP

Guidance for Industry for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products 人药和兽药无菌工艺验证申报资料的工业指南 Center for Drug Evaluation and Research (CDER) Center for Veterinary Medicine (CVM) November 1994 CMC 2 FDA 药品评价与研究中心（CDER ） FDA 兽药中心（CVM ） 1994 年11 月 TABLE OF CONTENTS I. INTRODUCTION 1 A. Purpose 1 B. Documenting Sterilization Process Validation 2 C. Remarks 2 II. INFORMATION FOR TERMINAL MOIST HEAT STERILIZATION PROCESSES 3 A. Description of the Process and Product ……………………………3 1. The Drug Product and Container-Closure System 3 2. The Sterilization Process 3 3. The Autoclave Process and Performance Specifications 4 4. Autoclave Loading Patterns 4 5. Methods and Controls to Monitor Production Cycles 4 6. Requalification of Production Autoclaves 4 7. Reprocessing 4 B. Thermal Qualification of the Cycle 4 1. Heat Distribution and Penetration Studies 4 2. Thermal Monitors 5 3. The Effects of Loading on Thermal Input 5 4. Information Included in the Batch Record . 5 C. Microbiological Efficacy of the Cycle 5 1. Identification and Characterization of Bioburden Organisms ……………. 6 2. Specificat