Solid Oral Dose Process Validation The Basics, Volume 1 /

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...

Celý popis

Uloženo v:
Podrobná bibliografie
Hlavní autor: Pazhayattil, Ajay Babu (Autor)
Médium: Elektronický zdroj E-kniha
Jazyk:angličtina
Vydáno: Cham : Springer International Publishing, 2018.
Vydání:1st ed. 2018.
Edice:AAPS Introductions in the Pharmaceutical Sciences,
Témata:
Pharmaceutical technology.
Pharmacy.
ISBN:9783030024727
ISSN:2522-834X
On-line přístup: Získat plný text
Tagy: Přidat tag
Žádné tagy, Buďte první, kdo vytvoří štítek k tomuto záznamu!
Obsah:
  • 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.

Podobné jednotky