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

• Main Authors: Pazhayattil, Ajay (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), Ingram, Marzena (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, 2019.
• Edition: 1st ed. 2019.
• Series: AAPS Introductions in the Pharmaceutical Sciences,
• Subjects: 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...