Table of Contents
Sterile Drug Products
Microbiological Risk
Relatively Low-Risk
Relatively High-Risk
Sterility is built into a product through production processes and controls.
Evaluation Factors Sterile Products
Complexity of Compounding
Facilities and Equipment
Training
Testing and Quality Assurance
Evaluation Factors Sterile Products
Tentative Conclusion
Advice Requested
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Author: CDER User
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