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

Published: 2003

Total Pages: 480

ISBN-13:

DOWNLOAD EBOOK

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


Handbook of Validation in Pharmaceutical Processes, Fourth Edition

Handbook of Validation in Pharmaceutical Processes, Fourth Edition

Author: James Agalloco

Publisher: CRC Press

Published: 2021-10-28

Total Pages: 1062

ISBN-13: 1000436012

DOWNLOAD EBOOK

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


Pharmaceutical Manufacturing Handbook

Pharmaceutical Manufacturing Handbook

Author: Shayne Cox Gad

Publisher: John Wiley & Sons

Published: 2008-04-04

Total Pages: 857

ISBN-13: 0470259825

DOWNLOAD EBOOK

With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.


Pharmaceutical Computer Systems Validation

Pharmaceutical Computer Systems Validation

Author: Guy Wingate

Publisher: CRC Press

Published: 2016-04-19

Total Pages: 773

ISBN-13: 1420088955

DOWNLOAD EBOOK

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. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.


GAMP 5

GAMP 5

Author: Sion Wyn

Publisher:

Published: 2008

Total Pages: 0

ISBN-13: 9781931879613

DOWNLOAD EBOOK

GAMP 5 provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner. This technical document describes a flexible risk-based approach to compliant GxP regulated computerized systems, based on scalable specification and verification. It points to the future of computer systems compliance by centering on principles behind major industry developments such as PQLI; ICH Q8, Q9, Q10; and ASTM E2500. This revolutionary Guide addresses the entire lifecycle of an automated system and its applicability to a wide range of information systems, lab equipment, integrated manufacturing systems, and IT infrastructures. It contains new information on outsourcing, electronic batch recording, end user applications (such as spreadsheets and small database applications), and patch management.


Handbook of Bioequivalence Testing

Handbook of Bioequivalence Testing

Author: Sarfaraz K. Niazi

Publisher: CRC Press

Published: 2014-10-29

Total Pages: 992

ISBN-13: 1482226383

DOWNLOAD EBOOK

As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence. In addition, advances in the analytical technology used to detect drug and metabolite levels have m


Handbook of Research on Emerging Technologies for Effective Project Management

Handbook of Research on Emerging Technologies for Effective Project Management

Author: Jamil, George Leal

Publisher: IGI Global

Published: 2019-09-13

Total Pages: 433

ISBN-13: 1522599940

DOWNLOAD EBOOK

Driven by such tools as big data, cognitive computing, new business models, and the internet of things, the overall demand for innovation is becoming more critical for competitiveness and emerging technologies. These technologies have become real alternatives for the market and offer new perspectives for modern project management applications. The Handbook of Research on Emerging Technologies for Effective Project Management is an essential research publication that proposes innovations for firms and markets through the exploration of project management principles and methods and the effective integration of knowledge and innovation. It encompasses academic and scientific propositions, reviews for conceptual bases, applications of theories in new market solutions, and cases of successful insertion of disruptive technologies and business models in new competitive market offers. Featuring a range of topics such as innovation management, business administration, and marketing, this book is ideal for project managers, IT specialists, software developers, executives, practitioners, managers, marketers, researchers, and industry professionals.


The Certified Pharmaceutical GMP Professional Handbook, Second Edition

The Certified Pharmaceutical GMP Professional Handbook, Second Edition

Author: Mark Allen Durivage

Publisher: Quality Press

Published: 2016-05-26

Total Pages: 386

ISBN-13: 0873899334

DOWNLOAD EBOOK

The purpose of this handbook is to assist individuals for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and provide a reference for the practitioner. The second edition reflects the Body of Knowledge which was updated in 2015. This edition has also incorporated additional information including updated references. The updates reflect the current trends and expectations of the evolving pharmaceutical industry driven by consumer expectations and regulatory oversight. This handbook covers compliance with good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, and combination devices, as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients), and packaging and labeling operations.