This Second Edition has been significantly expanded and updated to keep pace with advances in science and technology.

Parenteral Medications • Volume 3 is a valuable compilation of the current situation in regulatory issues as well as some of the technical problems associated with parenteral drug production.

The book is very well written for scientists and engineers in the pharmaceutical industry and academia.

Contents

1. Quality Assurance
2. Records and Reports
3. Particulate Matter
4. Validation of Sterilization Processes and Sterile Products
5. Federal Regulation of Parenterals
6. Systematic Audits of Parenteral Drug Good Manufacturing Practices
7. Medical Devices: Design, Manufacture, and Quality Control
8. Quality Assurance for Medical Devices
9. Regulatory and GMP Considerations for Medical Devices

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