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

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

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...

Πλήρης περιγραφή

Λεπτομέρειες βιβλιογραφικής εγγραφής
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.
Διαθέσιμο Online:Full Text via HEAL-Link
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.

Παρόμοια τεκμήρια