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Guidance Documents/Guidance-Document/Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products: Guidance for Industry

Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products: Guidance for Industry

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

November 1, 1994

May 5, 2020

Center for Drug Evaluation and Research

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