FDC Tablet : Quality Development & Pharmaceutical Process Validation.

      Аннотация: This is book (part 01), based on introduction, of the project entitled “Quality development and Pharmaceutical Process Validation of critical steps involved in manufacturing of 2-FDC tablets”. Introduction is most important part of any project. This study involves validating process variables of this product to show that process was under control the study was conducted on three validation batches, which includes validation of critical steps such as dry mixing, granulation, drying, lubrication, compression, coating overall manufacturing process was concluded as validated at the parameters mentioned above as per BMR and BMR.The raw materials required for these validation batches were procured from approved sources and were taken up for manufacturing after testing and release by Quality control. The raw materials were dispensed as per Standard Operating Procedure. The data has been compiled in such a way to feel it as “ready to use”. This book is not usual type book; we have tried to make it more reader friendly.

Ключевые слова: Quality assurance, quality risk management, validation, FDC tablets, Pharmaceutical Process