Sterilization Assurance Information and Data

This procedure provides the information required to support the sterility assurance of the drug product (product name), USP, manufactured by ABC Pharmaceutical Industries. It references the FDA Guidance titled Guidance for Industry for the Submission of Documentation for Sterilization Process Validation in Applications for Human and Veterinary Dmg Products prepared by the Sterility Technical Committee of the Chemistry Manufacturing Controls Coordinating Committee of the Center for Dmg Evaluation and Research (CDER) and the Center for Veterinary Medicine (CVM) in November of 1994. 

The required information as outlined in sections IV and V of the EDA Guidance is in boldface type, followed by ABC Pharmaceutical Industries information. It is submitted in the ANDA file for the manufacturing of (product name) USP. Other sections of the Guidance (sections I to III) pertain to the Guidance s introduction and terminal sterilization processes. 

This document contains information related to the liquid aseptic fill operation used in the manufacture of (product name), USP, at ABC Pharmaceutical Industries located at (provide postal address). Additional information to support the liquid aseptic filling validation includes but is not limited to environmental monitoring and controls, as well as product-specific testing such as bioburden and sterility testing. The main subsections are  

Information for aseptic fill manufacturing processes (reference FDA Guidance Section IV, A to J) 

Maintenance of microbiological control and quality (reference FDA Guidance Section V, A to C) 

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