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

by Emilija Fredro-Kumbaradzi, Ajay Pazhayattil, Naheed Sayeed-Desta

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 provides a direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Oral Dose Process Validation, Lifecycle...

• Format: Hardcover
• Language: English
• ISBN: 3030274837
• ISBN13: 9783030274832
• Release Date: September 2019
• Publisher: Springer
• Length: 108 Pages
• Weight: 0.77 lbs.
• Dimensions: 0.3" x 6.1" x 9.2"