Solid Oral Dose Process Validation, Volume Two Lifecycle Approach Application /

• Κύριοι συγγραφείς: Pazhayattil, Ajay (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), Ingram, Marzena (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, 2019.
• Έκδοση: 1st ed. 2019.
• Σειρά: AAPS Introductions in the Pharmaceutical Sciences,
• Θέματα: Pharmacology.; Pharmacy.; Pharmacology/Toxicology.

The textbook addresses the lifecycle concepts (Stage 1, 2, 3) of Process Validation. Regulatory bodies such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. Organizations have an opportunity to harmonize and align PV activities for all regulated markets. The concepts discussed pr...

Πίνακας περιεχομένων:

• Preface, Introduction, Chapter 1: Stage 1 Quality by Design Product Development QbD product development methodologies
• Chapter 2: Stage 1 Scale Up, Tech Transfer Process
• Considerations for process scale up and transfer
• Chapter 3: Stage 2 Batch determination, Sampling & Testing Plan
• PPQ batch determination method, scientifically supported sampling and testing plans
• Chapter 4: Stage 3A Continued Process Verification
• Stage 3A assessment methodology for newly launched products
• Chapter 5: Stage 3B Continued Process Verification
• Routine CPV monitoring plan for commercial products.