During the past decades, enormous progress and enhancement of pharmaceutical manufacturing equipment and its use have been made. And while there are support documents, books, articles, and online resources available on the principles of cleaning and associated processing techniques, none of them provides a single database with convenient, ready-to-use training tools. Until now. Cleaning Validation Manual: A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries elucidates how to train the man power involved in development, manufacturing, auditing, and validation of bio pharmaceuticals on a pilot scale, leading to scale-up production. With over 20 easy-to-use template protocols for cleaning validation of extensively used equipments, this book provides technical solutions to assist in fulfilling the training needs of finished pharmaceutical manufacturers. Drawing on the authors' more than two decades of experience in the pharmaceutical and biotech industries, the text offers hands-on training based on current approaches and techniques. The book does not merely provide guidelines or thought processes, rather it gives ready-to-use formulas to develop Master Plan, SOPs, and validation protocols. It includes cleaning procedures for the most commonly used equipment in various manufacturing areas and their sampling points, using a pharmaceutical manufacturing site with both sterile and non-sterile operations as the case facility. It also provides the training guidelines on downloadable resources to enable users to amend or adopt them as necessary. Grounded in practicality, the book's applicability and accessibility set it apart. It can be used as a guide for implementing a cleaning validation program on site without the help of external consultants, making it a resource that will not be found collecting dust on a shelf, but rather, referred to again and again.

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 evaluations, it features 64 new protocols on topics such as sterility assurance, media fill guidelines, and environmental control.

Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories presents cost-effective training courses that cover how to apply advances in the life sciences to produce commercially viable biotech products and services in terms of quality, safety, and efficacy. This book and its accompanying downloadable resources comprise detailed text, summaries, test papers, and answers to test papers, providing an administrative solution for management. Provides the FDA, Health Canada, WHO, and EMEA guidelines directly applicable to pharmaceutical laboratory-related issues Offers generic formats and styles that can be customized to any organization and help management build quality into routine operations to comply with regulatory requirements Contains ready-to-use training courses that supply a good source of training material for experienced and inexperienced practitioners in the biotechnology/biopharmaceutical industries Includes downloadable resources with downloadable training courses that can be adopted and directly customized to a particular organization Supplies ready-to-use test papers that allow end users to record all raw data up to the issuance of the attached certificate The biotechnology/bioscience industries are regulated worldwide to be in compliance with cGMP and GLP principles, with particular focus on safety issues. Each company must create a definite training matrix of its employees. The training procedures in this book enable end users to understand the principles and elements of manufacturing techniques and provide documentation language ranging from the generic to the specific. The training courses on the downloadable resources supply valuable tools for developing training matrices to achieve FDA, Health Canada, EMEA, MHRA UK, WHO, and GLP compliance.

Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories presents cost-effective training courses that cover how to apply advances in the life sciences to produce commercially viable biotech products and services in terms of quality, safety, and efficacy. This book and its accompanying downloadable resources comprise detailed text, summaries, test papers, and answers to test papers, providing an administrative solution for management. Provides the FDA, Health Canada, WHO, and EMEA guidelines directly applicable to pharmaceutical laboratory-related issues Offers generic formats and styles that can be customized to any organization and help management build quality into routine operations to comply with regulatory requirements Contains ready-to-use training courses that supply a good source of training material for experienced and inexperienced practitioners in the biotechnology/biopharmaceutical industries Includes downloadable resources with downloadable training courses that can be adopted and directly customized to a particular organization Supplies ready-to-use test papers that allow end users to record all raw data up to the issuance of the attached certificate The biotechnology/bioscience industries are regulated worldwide to be in compliance with cGMP and GLP principles, with particular focus on safety issues. Each company must create a definite training matrix of its employees. The training procedures in this book enable end users to understand the principles and elements of manufacturing techniques and provide documentation language ranging from the generic to the specific. The training courses on the downloadable resources supply valuable tools for developing training matrices to achieve FDA, Health Canada, EMEA, MHRA UK, WHO, and GLP compliance.

During the past decades, enormous progress and enhancement of pharmaceutical manufacturing equipment and its use have been made. And while there are support documents, books, articles, and online resources available on the principles of cleaning and associated processing techniques, none of them provides a single database with convenient, ready-to-use training tools. Until now. Cleaning Validation Manual: A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries elucidates how to train the man power involved in development, manufacturing, auditing, and validation of bio pharmaceuticals on a pilot scale, leading to scale-up production.

With over 20 easy-to-use template protocols for cleaning validation of extensively used equipments, this book provides technical solutions to assist in fulfilling the training needs of finished pharmaceutical manufacturers. Drawing on the authors more than two decades of experience in the pharmaceutical and biotech industries, the text offers hands-on training based on current approaches and techniques. The book does not merely provide guidelines or thought processes, rather it gives ready-to-use formulas to develop Master Plan, SOPs, and validation protocols. It includes cleaning procedures for the most commonly used equipment in various manufacturing areas and their sampling points, using a pharmaceutical manufacturing site with both sterile and non-sterile operations as the case facility. It also provides the training guidelines on a CD-ROM to enable users to amend or adopt them as necessary.

Grounded in practicality, the book s applicability and accessibility set it apart. It can be used as a guide for implementing a cleaning validation program on site without the help of external consultants, making it a resource that will not be found collecting dust on a shelf, but rather, referred to again and again.

All manufacturing companies face the daunting task of designing an employee training matrix that meets the gamut of national and international regulatory standards. Answering the call for a one-stop training resource that focuses exclusively on this multi-faceted, high-tech industry, Biotechnology: A Comprehensive Training Guide for the Biotechnology Industry provides ready-to-implement training templates that save time and expense without cutting corners on critical elements. Downloadable Resources: Why Reinvent the Wheel? This complete, single-source reference contains 28 complete biotechnology courses and a customizable downloadable resources with hands-on training tools. The book also provides time-saving information on how to orient employees involved in writing and executing batch manufacturing and in-process control documents. Key Benefits: Contains adaptable training text, test summaries and papers, test answers, and certificates of completion Streamlines the training process, maximizing efficiency Boosts the marketing edge over competitors This valuable training tool presents step-by-step guidance for optimizing research and development expenditures, avoiding marketing delays, gaining a competitive advantage, reducing product development failures, developing skilled manpower, and maintaining local and international regulatory compliance.

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 evaluations, it features 64 new protocols on topics such as sterility assurance, media fill guidelines, and environmental control.

Don't reinvent the wheel when applying for your ISO 9001 registration or updating to the new 2000 standards. ISO 9001:2000 Document Development Compliance Manual: A Complete Guide and CD-ROM shows you how to develop and implement a documented quality management system based on ISO 9000 series standards. It supplies ready to use ISO 9001:2000 Template Quality Manuals and applicable Standard Operating Procedures with year 2000 revisions for documentation management in text and on CD ROM.
You will understand how to:
o Build quality into your products and services
o Achieve ISO 9001 certification with time, money, and resources optimization
o Supply products that are totally fit for use
o Satisfy user/customer expectations
o Edge out the competitors
o Achieve a defined level of quality
o Prevent defects and provide value
o Yield profits from your invested resources