Sterile Drug Products

8/20/01


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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

Author: CDER User