Validation Standard Operating Procedures

Validation Standard Operating Procedures
Author: Syed Imtiaz Haider
Publisher: CRC Press
Total Pages: 1144
Release: 2006-05-30
Genre: Medical
ISBN: 1420009419

Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluati

Validating Chromatographic Methods

Validating Chromatographic Methods
Author: David M. Bliesner
Publisher: John Wiley & Sons
Total Pages: 301
Release: 2006-09-11
Genre: Science
ISBN: 0470042192

All the information and tools needed to set up a successful method validation system Validating Chromatographic Methods brings order and Current Good Manufacturing Practices to the often chaotic process of chromatographic method validation. It provides readers with both the practical information and the tools necessary to successfully set up a new validation system or upgrade a current system to fully comply with government safety and quality regulations. The net results are validated and transferable analytical methods that will serve for extended periods of time with minimal or no complications. This guide focuses on high-performance liquid chromatographic methods validation; however, the concepts are generally applicable to the validation of other analytical techniques as well. Following an overview of analytical method validation and a discussion of its various components, the author dedicates a complete chapter to each step of validation: Method evaluation and further method development Final method development and trial method validation Formal method validation and report generation Formal data review and report issuance Templates and examples for Methods Validation Standard Operating Procedures, Standard Test Methods, Methods Validation Protocols, and Methods Validation Reports are all provided. Moreover, the guide features detailed flowcharts and checklists that lead readers through every stage of method validation to ensure success. All of the templates are also included on a supplementary support site, enabling readers to easily work with and customize them. For scientists and technicians new to method validation, this guide provides all the information and tools needed to develop a top-quality system. For those experienced with method validation, the guide helps to upgrade and improve existing systems.

Evolution of Translational Omics

Evolution of Translational Omics
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 354
Release: 2012-09-13
Genre: Science
ISBN: 0309224187

Technologies collectively called omics enable simultaneous measurement of an enormous number of biomolecules; for example, genomics investigates thousands of DNA sequences, and proteomics examines large numbers of proteins. Scientists are using these technologies to develop innovative tests to detect disease and to predict a patient's likelihood of responding to specific drugs. Following a recent case involving premature use of omics-based tests in cancer clinical trials at Duke University, the NCI requested that the IOM establish a committee to recommend ways to strengthen omics-based test development and evaluation. This report identifies best practices to enhance development, evaluation, and translation of omics-based tests while simultaneously reinforcing steps to ensure that these tests are appropriately assessed for scientific validity before they are used to guide patient treatment in clinical trials.

Validation Fundamentals

Validation Fundamentals
Author: William Gibson
Publisher: CRC Press
Total Pages: 248
Release: 1998-04-30
Genre: Medical
ISBN: 9781574910704

Written by the founders of the Institute of Validation, this practical introduction to validation cuts through all the jargon and focuses on the essentials. Whether you are a novice or an experienced validator, this book will help you understand validation fundamentals and ways in which these principles can be bonded with quality assurance, enabling you to build the highest quality into your products. Beginning with definitions of validation, the authors guide you through all the basics, associated costs, responsibilities, policies, strategies, support activities, SOPs, Master Plans, and other related subjects. Packed with tools to help you follow the logic of the validation process, the book covers testing, certification, protocols, final reports, sign-offs, ways to create seamless audit trails, and other topics impacting the qualification of a system, equipment, and/or process.

Pharmaceutical and Medical Device Validation by Experimental Design

Pharmaceutical and Medical Device Validation by Experimental Design
Author: Lynn D Torbeck
Publisher: CRC Press
Total Pages: 272
Release: 2007-06-26
Genre: Medical
ISBN: 1420055704

This title demonstrates how designed experiments are the most scientific, efficient, and cost effective method of data collection for validation in a laboratory setting. Intended as a learn-by-example guide, Pharmaceutical and Medical Device Validation by Experimental Design demonstrates why designed experiments are the most logical and rational ap

Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry

Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry
Author: Stephen Robert Goldman
Publisher: 1st Book Library
Total Pages: 480
Release: 2003
Genre: Business & Economics
ISBN:

This handbook details methods for sustainable compliance with GxPs and 21 CFR Part 11 validation requirements regarding computerized systems in the pharmaceutical, biotechnology, and medical device industry. The handbook follows FDA guidelines and best industry practices in defining roles, responsib

Validating Clinical Trial Data Reporting with SAS

Validating Clinical Trial Data Reporting with SAS
Author: Carol I. Matthews
Publisher: SAS Institute
Total Pages: 229
Release: 2008
Genre: Computers
ISBN: 1599941287

This indispensable guide focuses on validating programs written to support the clinical trial process from after the data collection stage to generating reports and submitting data and output to the Food and Drug Administration.

Quality Operations Procedures for Pharmaceutical, API, and Biotechnology

Quality Operations Procedures for Pharmaceutical, API, and Biotechnology
Author: Syed Imtiaz Haider
Publisher: CRC Press
Total Pages: 580
Release: 2012-06-06
Genre: Medical
ISBN: 143988692X

To stay in compliance with regulations, pharmaceutical, medical, and biotech companies must create qualtiy SOPs that build in the regulatory requirements into actions and describe personal flow, internal flow, flow of information, and processing steps. Quality Operations Procedures for Pharmaceutical, API, and Biotechnology and the accompanying CD-