Informationen zum Autor Stanley Nusim Klappentext To successfully bring an Active Pharmaceutical Ingredient (API) to market, many steps must be followed to ensure compliance with governmental regulations. This book is an unparalleled guide to the development, manufacturing, and regulation of the preparation and use of APIs globally. This secoond edition brings readers up-to-date with the quality control regulations for APIs that have been added or amended since the first edition. These updates help ensure that pharmaceutical professionals and drug manufacturers meet the established and required guidelines set forth by the US and international regulatory industries. Zusammenfassung Active Pharmaceutical Ingredients Inhaltsverzeichnis 1. Introduction. 2. Process Development, Scaleup, and Design. 3. Technology Transfer and First Manufacture. 4. Plant Design and Construction. 5. Regulatory Requirements: US. 6. Regulatory Requirements: Outside US. 7. Process Validation. 8. Quality Assurance and Control. 9. Environmental Control. 10. Safety. 11. Plant Operations. 12. Bulk Sterile Manufacturing. 13. Materials Management. 14. Plant Maintenance.

Autorentext

Stanley Nusim

Klappentext

To successfully bring an Active Pharmaceutical Ingredient (API) to market, many steps must be followed to ensure compliance with governmental regulations. This book is an unparalleled guide to the development, manufacturing, and regulation of the preparation and use of APIs globally. This secoond edition brings readers up-to-date with the quality control regulations for APIs that have been added or amended since the first edition. These updates help ensure that pharmaceutical professionals and drug manufacturers meet the established and required guidelines set forth by the US and international regulatory industries.

Zusammenfassung
Active Pharmaceutical Ingredients

Inhalt

1. Introduction. 2. Process Development, Scaleup, and Design. 3. Technology Transfer and First Manufacture. 4. Plant Design and Construction. 5. Regulatory Requirements: US. 6. Regulatory Requirements: Outside US. 7. Process Validation. 8. Quality Assurance and Control. 9. Environmental Control. 10. Safety. 11. Plant Operations. 12. Bulk Sterile Manufacturing. 13. Materials Management. 14. Plant Maintenance.