Cost Rationalization in Pharmaceutical Production
by William Whyte
The pharmaceutical industry is facing increasing pressure to reduce costs, in order to remain competitive. This can be achieved through a variety of ways like cost reduction through sustainable manufacturing strategies, developing a streamlined and consistent global supply network, identifying global suppliers and controlling COGS throughout the product development and manufacturing lifecycle. With low-cost manufacturing, high-quality research and manufacturing facilities and educated personnel, the Indian pharmaceutical industry presents both a competitive threat and partner opportunities. This has resulted in increasing its manufacturing capability to competetive international levels, so that it is fast emerging as a sourcing partner for international pharma majors. India now has the largest number of US FDA approved plants outside the USA and boasts of permanent facilities of USP and US FDA due to the large number of regulated pharma manufacturing facilities.
This book for the first time provides a rare insight into the nitty-gritty workings of Indian pharma companies, how they have managed to bring down the cost of manufacturing to surprisingly low levels while maintaining compliance with world regulatory authorties. With the unique angle of supply chain opportunities, this book provides a scientific study of cost rationalization in production giving numerous examples, case studies, tables/charts and illustrations. Pharmaceutical companies worldwide can now tap into the management resources of Indian pharma companies for obtaining unique cost leverage and control cost of production. This is a very focussed and coincise book dealing exclusively for the first time on cost rationalization in pharmaceutical production through the route of supply chain gaps and opportunities.
Quality Control of Herbal Drugs
The most exhaustive and comprehensive book ever available on the subject:
Ethnobotany in Drug Evaluation
Development of Standardization Parameters
Phytoconstituents and Their Analysis
Extraction of Herbal Drugs
TLC - Detailed Procedures and Guidelines
HPTLC - Densitometry
Pharmacological Screening of Herbal Drugs
Good Agricultural and Harvesting Practices
Quality Assurance and Stability Testing of Herbal Drugs
Analytical Profiles of Selected Medicinal Plants
Standardization of Botanicals, Vol. 1
There has been a resurgence in usage of herbal medicine in the past few years, not only among the traditional medicine users (ethno-medicine) but also among the modern consumers of herbal products. This is supplemented with all round growth of similar natural products among the nutritional supplements and personal care segments. The question of quality therefore acquires greater importance today than ever before.
While there are some books available on identification, description, pharmacological action, safety aspects etc. of medicinal herbs, very few books can be found on quantitative testing of medicinal herbs. This book fulfills that gap in knowledge base with detailed, ready to use and validated methods of analysis to be perfomed in a quality control laboratory. This book will be welcomed by all those who are concerned about the standardization of botanicals as it provides analytical procedures for extracts as well as phytochemicals.
This book is an attempt to provide, not only the quantitative testing methods but also chemical constituents, extraction processes, specifications of various extracts, therapeutic functions, dosage, pharmacological properties, toxicity/safety aspects and references. Volume I of this book contains 25 widely used medicinal herbs.
Standardization of Botanicals, Vol. 2
Testing of medicinal herbs and their derivatives like extracts, phytochemicals, oleoresins etc has all along been a difficult and controversial subject due to the complex nature of the active constituents of the medicinal herbs found wild or cultivated in various regions of the world. An effort is on to include, at least some testing methods, in various pharmacopoeias but there is still a wide gap between the medicinal herbs and their testing methods. This book containing 25 monographs of medicinal herbs fills that gap in knowledge base with detailed, ready to use and validated extraction processes and methods of testing to be performed in a well-equipped testing laboratory.
Volume I with 25 monographs was published in 2002 which was perhaps one of the very few books providing specifications and testing methods for various types of herbal extracts like soft extracts, dry extracts and phytochemicals. Most of the data provided was based on the hands-on experience of the author Dr. V. Rajpal who has been constantly associated with the testing as well as processing of medicinal herbs and their derivatives since 1976 in an industrial setting. His experience of providing consultancy for setting up herb processing and testing laboratories led to his in-depth knowledge of problems faced by the herb processing factories and quality control laboratories.
Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices
THE GOLD STANDARD FOR STERILE MANUFACTURING
Injectable product manufacturing is booming because of the growth of new biopharmaceuticals and small molecule anticancer drugs. The requirements for contamination control will become even more stringent than today. Isolators or blow-fill-seal equipment have already replaced the conventional clean rooms and LAF-hoods in many production facilitities. Conventional microbiological monitoring methods, requiring 3 to 5 days of incubation will become inappropriate. Equipment is already available allowing real time, simultaneous viable and non-viable counting.
This book is a useful reference guide for the SMB (Small and Medium Business) pharmaceutical sector which does not have the resources to have access to such top-quality information in this field. This book therefore represents an unparalleled and unprecedented text in the field of pharmaceutical and medical device microbiology. Perhaps even more outstanding is the fact that this book not only covers subject matter and technical content which is established as best and expected practice, but also includes content regarded as possible, future and emerging technology or processes.