Solid Oral Dose Process Validation The Basics, Volume 1 /

• 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.

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...