Description

Quality is a very important tool in pharmaceutical industry and it is a prime area of concern for regulatory agencies across the globe, in order to facilitate production of medicines without batch-to-batch variations and hence maintaining the same therapeutic effectiveness, as this is a vital segment of our healthcare system. With the advent of total quality management, a new vista has opened for assured quality of pharmaceuticals. The present work also involves application of total quality management practices of orodispersible tablet formulations. This technique is widely applied in multinational pharmaceutical industry, but literature about detailed practical aspects of total quality management is not available. Therefore, quality management approach used in pharmaceutical industries through documentation viz. preparation of master formula record, batch production record and process validation report was applied for developed formulations i.e. orodispersible tablets of paracetamol. This book is an attempt to provide experimental insights into the concept of total quality management for easier understanding of this widely applicable industrial and regulatory aspect.