Bøger af Manohar a Potdar

Indian pharmaceutical industry is becoming global at high pace. This resulted in high pressure on the industry for quality products and practices. Thus cGMP has acclaimed Key position.Practicing cGMP requires clear understanding at conceptual and implementation level and that too at shop floor and middle management level. This book is written in simple and easy to implement manner.Salient features All current issues of cGMP demanded by regulatory authorities like W.H.O. M.H.R.A., T.G.A., U.S.F.D.A, and also Indian F.D.A. are fully discussed, profusely referenced and thoroughly illustrated in simple and easy to understand language. Covers other important topics like, plant, site security, environmental issues, distribution of products, and preparing for the regulatory audits etc.

Designing, erection and commissioning of a pharmaceutical plant is a long drawn process. It needs basic understanding of pharmaceutical formulations and their logical and sequential processing. This whole process is tedious, time consuming and should have proper guidance in this regard. The book will provide such guidance which is a long felt need by the industry.Salient Features:· Pharmaceutical design aspects with sample layouts for all major formulations are discussed· All aspects related to project management, regulatory requirements, validation of facilities, HVAC and water system are discussed· A real handy book for all those who are involved in plant design, project management and facility and utilities validation in Pharmaceutical industry.

In managing the Quality, why we do something is more important than what we do. The purpose of this book is to explain this basis of Quality management to those who need to know in pharmaceutical industry.This book explains the above view with reference to pharma industry with the help of principles of quality advocated by the genius like Dr. Joseph Juran in simple to understand language.The book will be very useful to the postgraduate students of pharmacy and practicing quality managers in pharma industry.

This book is a 'MUST READ', for Post Graduate pharmacy students who want to make their career in Plant Management and also for those who are already in the pharma industry. It provides a fundamental understanding of management concepts and its applications to pharmaceutical plant management.Salient Features:1. It lucidly explains the concepts of management.2. Describes in simple language how a typical pharmaceutical plant is organized and functions.3. A good text for M. Pharm students and also for the practicing industrial pharmacists.

Quality by design (QbD) is extensively used tool in formulation and development. QbD is a method of choice in product development for robust and quality product incorporating continuous improvement. The objective of the book is to study the implementation of QbD and wide-ranging QbD based product development template for different formulations and analytical procedures. The way QbD is implemented in Pharmaceutical Industry, Academicians/ Institutes are way behind in this competition. The reason being, concepts of QbD are poorly explored byPharma Researchers due to nonexistence of expertise and resources. Researchers tend to adapt moderately the principles of QbD due to inadequate understanding of QbD principles. The use of QbD in formulation development will be advantageous to young researchers and academics.