Sujan,
The FDA Guidance for Industry for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products | FDA clearly defines what type of information and data should be submitted in support of the efficacy of sterilization processes, including terminal sterilization. The guidance is quite old (from 1994), but still valid, and also applicable for ANDAs. The focus for TS should mostly be on the autoclave process, thermal qualification of the autoclave cycle, microbial efficacy of the cycle, summary of how microbial monitoring of the environment is done, CCIT, and other release testing (endotox, sterility).
You should provide this information in CTD sections 3.2.P.3.3, 3.2.P.3.5, and for testing in sections 3.2.P.5.1-6 and P.8.1-3.
Information in ANDAs for depyrogenation tunnel validation should be included for aseptic processes, not for TS.
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Ronald Ullers
Venn Life Sciences
Breda
Netherlands
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Original Message:
Sent: 11-Mar-2024 23:20
From: SUJAN BOSE
Subject: Sterility Assurance for TS ANDA
Dear Experts,
What types of documents would you suggest to include in an liquid filled glass vial (Terminally Sterilized) ANDA package to ensure its Sterility?
For Example - CCIT, Autoclave validation, Depyrogenation tunnel validation etc.
Thanks in advance
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SUJAN BOSE
Senior Executive
Global Regulatory Affairs (Drugs)
SPPLC. (Bangladesh)
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