Solid Oral Dose Process Validation The Basics, Volume 1 /

• Κύριοι συγγραφείς: Pazhayattil, Ajay Babu (Συγγραφέας, http://id.loc.gov/vocabulary/relators/aut), Sayeed-Desta, Naheed (http://id.loc.gov/vocabulary/relators/aut), Fredro-Kumbaradzi, Emilija (http://id.loc.gov/vocabulary/relators/aut), Collins, Jordan (http://id.loc.gov/vocabulary/relators/aut)
• Συγγραφή απο Οργανισμό/Αρχή: SpringerLink (Online service)
• Μορφή: Ηλεκτρονική πηγή Ηλ. βιβλίο
• Γλώσσα: English
• Έκδοση: Cham : Springer International Publishing : Imprint: Springer, 2018.
• Έκδοση: 1st ed. 2018.
• Σειρά: AAPS Introductions in the Pharmaceutical Sciences,
• Θέματα: Pharmaceutical technology.; Pharmacy.; Pharmaceutical Sciences/Technology.

Currently there are no process validation (PV) textbooks addressing the lifecycle concepts (Stage 1, 2, 3). Recent regulatory guidance's such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. The concepts are now harmonized across regulatory guidance's and organizations...

Πίνακας περιεχομένων:

• Volume One.Preface
• Lifestyle Approach to Validation
• Solid Dose Formulations
• Stage 1A Process Design: Quality by Design
• Knowledge Management and Risk Assessment for Lifestyle Stages
• .Stage 1B Process and Scale Up Considerations
• Stage 2A and 2B Process Qualifications
• Stage 3A and 3B: Continued Process Verification.