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Get Guidance For Industry The Submission Documentation For Sterilization Process Validation In

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. 16 Preservative Effectiveness. 17 VI. Pyrogen or Endotoxin Testing. 17 ADDITIONAL INFORMATION. 17 GUIDANCE FOR INDUSTRY1 FOR THE SUBMISSION OF DOCUMENTATION FOR STERILIZATION PROCESS.

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