A major new work on all aspects of water, the most used raw material ingredient in the pharmaceutical and biotechnology industries-used as an excipient in pharmaceutical formulations, as a cleaning agent, and as a separately packaged product diluent.Drawing on the author's extensive field experience with more than 400 pharmaceutical and related wat
Comprehensive Water Quality and Purification, Four Volume Set provides a rich source of methods for analyzing water to assure its safety from natural and deliberate contaminants, including those that are added because of carelessness of human endeavors. Human development has great impact on water quality, and new contaminants are emerging every day. The issues of sampling for water analysis, regulatory considerations, and forensics in water quality and purity investigations are covered in detail. Microbial as well as chemical contaminations from inorganic compounds, radionuclides, volatile and semivolatile compounds, disinfectants, herbicides, and pharmaceuticals, including endocrine disruptors, are treated extensively. Researchers must be aware of all sources of contamination and know how to prescribe techniques for removing them from our water supply. Unlike other works published to date that concentrate on issues of water supply, water resource management, hydrology, and water use by industry, this work is more tightly focused on the monitoring and improvement of the quality of existing water supplies and the recovery of wastewater via new and standard separation techniques Using analytical chemistry methods, offers remediation advice on pollutants and contaminants in addition to providing the critical identification perspective The players in the global boom of water purification are numerous and varied. Having worked extensively in academia and industry, the Editor-in-Chief has been careful about constructing a work for a shared audience and cause
This title focuses on the comprehension of the properties of water in foods, enriched by the approaches from polymer and materials sciences, and by the advances of analytical techniques. The International Symposium on the Properties of Water (ISOPOW) promotes the exchange of knowledge between scientists involved in the study of food materials and scientists interested in water from a more basic point of view and the dialogue between academic and industrial scientists/technologists. This comprehensive book covers the topics presented at the 10th ISOPOW held in Bangkok, Thailand in 2007, including water dynamics in various systems, the role of water in functional food and nano-structured biomaterials. Special features include: Latest findings in the properties of water in food, pharmaceutical and biological systems Coverage of the 10th International Symposium on the Properties of Water (ISOPOW) Includes water dynamics, water in foods stability, and water in micro and nano-structured food and biomaterials Reflects the vast array of research and applications of water world wide
Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine va
This report calls for a better understanding of the effects of pharmaceutical residues in the environment, greater international collaboration and accountability distribution, and policy actions to prevent and remedy emerging concerns. Laboratory and field tests show traces of oral contraceptives causing the feminisation of fish and amphibians, and residues of psychiatric drugs altering fish behaviour. Antimicrobial resistance, linked to the overuse of antibiotics, has rapidly escalated into a global health crisis. Unless adequate measures are taken to manage the risks, pharmaceutical residues will increasingly be released into the environment as ageing populations, advances in healthcare, and intensification of meat and fish production spur the demand for pharmaceuticals worldwide. The report outlines a collective, life‑cycle approach to managing pharmaceuticals in the environment. A policy mix of source‑directed, use‑orientated and end‑of‑pipe measures, involving several policy sectors, can help to improve health and protect the environment.
This volume is intended to provide the reader with a breadth of understanding regarding the many challenges faced with the formulation of poorly water-soluble drugs as well as in-depth knowledge in the critical areas of development with these compounds. Further, this book is designed to provide practical guidance for overcoming formulation challenges toward the end goal of improving drug therapies with poorly water-soluble drugs. Enhancing solubility via formulation intervention is a unique opportunity in which formulation scientists can enable drug therapies by creating viable medicines from seemingly undeliverable molecules. With the ever increasing number of poorly water-soluble compounds entering development, the role of the formulation scientist is growing in importance. Also, knowledge of the advanced analytical, formulation, and process technologies as well as specific regulatory considerations related to the formulation of these compounds is increasing in value. Ideally, this book will serve as a useful tool in the education of current and future generations of scientists, and in this context contribute toward providing patients with new and better medicines.
The ASQ Certified Pharmaceutical GMP Professional Handbook assists candidates preparing for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and serves as a handy reference guide for practitioners in the field. This handbook covers compliance with good manufacturing practices (GMPs) as regulated and guided by national and international agencies for the pharmaceutical industry.
Quality assurance of pharmaceutical products is a continuing concern of WHO. Despite efforts made around the world to ensure a supply of quality and effective medicines, substandard, spurious and counterfeit products still compromise health care delivery in many countries. To respond to the global need for adequate quality assurance of pharmaceuticals, WHO's Expert Committee on Specifications for Pharmaceutical Preparations has over the years made numerous recommendations to establish standards and guidelines and to promote the effective functioning of national regulatory and control systems and the implementation of internationally agreed standards by trained personnel. Many of the relevant documents endorsed by the Committee are reproduced in this volume providing guidance covering all aspects of good manufacturing practices (GMP). Important texts on inspection are also included. Most of the material has been published separately in the Expert Committee's reports. This compendium brings it together to make it more accessible and of greater practical value to those working in faculties of pharmacy, in medicines regulation and control and in the pharmaceutical industry. This is the second updated edition of the compendium and includes texts published in 2005 and 2006 in the WHO Technical Report Series.
Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals. Key Features: Provides an in-depth discussion of recent advances in sterilization Identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions Explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture