Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice.
It is estimated that 80 to 90% of drugs under development never make it to the marketplace due to insufficient clinical activity, unacceptable toxicity, rapid appearance of drug resistance, or other factors that should be, at least partially, predictable from preclinical testing.
Written by an expert for those who must design validatable cleaning processes and then validate those processes, this book discusses interdependent topics from various technical areas and disciplines.
Knowing how to deal with the regulatory issues, understanding the impacts of cleanliness, and recognizing the affect that poor facility layout will have on GMP spaces are only some of the issues an experienced Project Manager must focus on.
Contamination control in pharmaceutical clean rooms has developed from a jumble of science and engineering, knowledge of what has worked well or badly in the past, dependent upon the technology available at the time the clean room was built and subsequent technological developments.
An invaluable source instruction on the principles, instrumentation, design, implementation, operation, and maintenance of an effective clean-in-place system (CIP), this guide illustrates best practices and successful applications of CIP in both pharmaceutical and biotechnology facilities.
A critical technology in the science of contamination control, environmental monitoring is a technique that provides important data on the quality of a process, processing environment, and final product, which can aid scientists in identifying and eliminating potential sources of contamination in cleanrooms and controlled environments.
This thoroughly authoritative work furnishes organizational, technological, validation, project management, and business perspectives on pharmaceutical information automation from industry and system automation professionals-demonstrating how to fulfill computer system validation requirements for hardware, applications, networks, data center operat
This practical book provides detailed guidance on all aspects of clean room airflow, the mechanics of airflow, and how microbial contamination is carried.
This practical book provides detailed guidance on all aspects of clean room airflow, the mechanics of airflow, and how microbial contamination is carried.
This book presents vital information on international sterilization standards and guidance on practical application of these standards in the manufacturing process.
This book presents vital information on international sterilization standards and guidance on practical application of these standards in the manufacturing process.
The validation and radiation sterilization process for biomaterials and medical devices requires careful planning to ensure regulatory compliance followed by precise accuracy in execution and documentation.
The validation and radiation sterilization process for biomaterials and medical devices requires careful planning to ensure regulatory compliance followed by precise accuracy in execution and documentation.
Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations.
First Published in 1989 this is a collection of essays based on a series of lectures given at a symposium held at the University of Southampton Medical School from eight experts in the field of growth failure.
First Published in 1989 this is a collection of essays based on a series of lectures given at a symposium held at the University of Southampton Medical School from eight experts in the field of growth failure.
An informative and comprehensive book on the applications and techniques of dried blood spot sampling Dried blood spot (DBS) sampling involves the collection of a small volume of blood, via a simple prick or other means, from a study subject onto a cellulose or polymer paper card, which is followed by drying and transfer to the laboratory for analysis.
An informative and comprehensive book on the applications and techniques of dried blood spot sampling Dried blood spot (DBS) sampling involves the collection of a small volume of blood, via a simple prick or other means, from a study subject onto a cellulose or polymer paper card, which is followed by drying and transfer to the laboratory for analysis.
By presenting the latest technological advances and growing national and international regulation, this new book explores state-of-the-art developments in the challenging field of tissue and cell processing.
By presenting the latest technological advances and growing national and international regulation, this new book explores state-of-the-art developments in the challenging field of tissue and cell processing.
