Solid Oral Dose Process Validation The Basics, Volume 1 /

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...

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Bibliographic Details
Main Authors: Pazhayattil, Ajay Babu (Author, 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)
Corporate Author: SpringerLink (Online service)
Format: Electronic eBook
Language:English
Published: Cham : Springer International Publishing : Imprint: Springer, 2018.
Edition:1st ed. 2018.
Series:AAPS Introductions in the Pharmaceutical Sciences,
Subjects:
Pharmaceutical technology.
Pharmacy.
Pharmaceutical Sciences/Technology.
Online Access:Full Text via HEAL-Link
Table of Contents:
  • 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.

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