Pharmaceutical Engineering Change Control

Pharmaceutical Engineering Change Control
Author: Simon G. Turner
Publisher: CRC Press
Total Pages: 200
Release: 2019-08-30
Genre:
ISBN: 9780367394745

Written especially for the pharmaceutical industry professional, this book addresses each part of the life-cycle of engineering change control. It covers issues in the EU and US and describes the operational requirements and responsibilities that ensure change controls are effectively applied and recorded. Providing guidance on how to demonstrate that a change control system is working, the book includes chapters on computer validation, customization of the change process to each project's needs, and case histories and anecdotes illustrate key points and provide a basis for change control training. It gives readers a toolbox for ensuring that adequate controls are implemented.

Practical Pharmaceutical Engineering

Practical Pharmaceutical Engineering
Author: Gary Prager
Publisher: John Wiley & Sons
Total Pages: 575
Release: 2018-11-28
Genre: Science
ISBN: 1119418844

A practical guide to all key the elements of pharmaceuticals and biotech manufacturing and design Engineers working in the pharmaceutical and biotech industries are routinely called upon to handle operational issues outside of their fields of expertise. Traditionally the competencies required to fulfill those tasks were achieved piecemeal, through years of self-teaching and on-the-job experience—until now. Practical Pharmaceutical Engineering provides readers with the technical information and tools needed to deal with most common engineering issues that can arise in the course of day-to-day operations of pharmaceutical/biotech research and manufacturing. Engineers working in pharma/biotech wear many hats. They are involved in the conception, design, construction, and operation of research facilities and manufacturing plants, as well as the scale-up, manufacturing, packaging, and labeling processes. They have to implement FDA regulations, validation assurance, quality control, and Good Manufacturing Practices (GMP) compliance measures, and to maintain a high level of personal and environmental safety. This book provides readers from a range of engineering specialties with a detailed blueprint and the technical knowledge needed to tackle those critical responsibilities with confidence. At minimum, after reading this book, readers will have the knowledge needed to constructively participate in contractor/user briefings. Provides pharmaceutical industry professionals with an overview of how all the parts fit together and a level of expertise that can take years of on-the-job experience to acquire Addresses topics not covered in university courses but which are crucial to working effectively in the pharma/biotech industry Fills a gap in the literature, providing important information on pharmaceutical operation issues required for meeting regulatory guidelines, plant support design, and project engineering Covers the basics of HVAC systems, water systems, electric systems, reliability, maintainability, and quality assurance, relevant to pharmaceutical engineering Practical Pharmaceutical Engineering is an indispensable “tool of the trade” for chemical engineers, mechanical engineers, and pharmaceutical engineers employed by pharmaceutical and biotech companies, engineering firms, and consulting firms. It also is a must-read for engineering students, pharmacy students, chemistry students, and others considering a career in pharmaceuticals.

Quality (Pharmaceutical Engineering Series)

Quality (Pharmaceutical Engineering Series)
Author: Kate McCormick
Publisher: Butterworth-Heinemann
Total Pages: 296
Release: 2002-09-24
Genre: Business & Economics
ISBN: 9780750651134

The Pharmaceutical Engineering Series is a comprehensive reference for the pharmaceutical professional covering all aspects from quality, documentation and validation through manufacturing processes to facility design and management. In 'Quality', Dr Kate McCormick provides the reader with comprehensive coverage of this vital subject, including the quality life cycle, management and cost of quality, GMP, auditing and inspections. This book with the others in the series will become a unique source of reference and educational material for the readership. Case studies and examples make the book of direct practical relevance to the professional in the pharmaceutical industry Find the answers you are looking for quickly and easily with clear indexing and referencing Reference to international standards and practice mean this book will be useful wherever you are working

Pharmaceutical Process Development

Pharmaceutical Process Development
Author: John Blacker
Publisher: Royal Society of Chemistry
Total Pages: 375
Release: 2011-08-17
Genre: Science
ISBN: 1849733074

Pharmaceutical process research and development is an exacting, multidisciplinary effort but a somewhat neglected discipline in the chemical curriculum. This book presents an overview of the many facets of process development and how recent advances in synthetic organic chemistry, process technology and chemical engineering have impacted on the manufacture of pharmaceuticals. In 15 concise chapters the book covers such diverse subjects as route selection and economics, the interface with medicinal chemistry, the impact of green chemistry, safety, the crucial role of physical organic measurements in gaining a deeper understanding of chemical behaviour, the role of the analyst, new tools and innovations in reactor design, purification and separation, solid state chemistry and its role in formulation. The book ends with an assessment of future trends and challenges. The book provides a valuable overview of: both early and late stage chemical development, how safe and scaleable synthetic routes are designed, selected and developed, the importance of the chemical engineering, analytical and manufacturing interfaces, the key enabling technologies, including catalysis and biocatalysis, the importance of the green chemical perspective and solid form issues. The book, written and edited by experts in the field, is a contemporary, holistic treatise, with a logical sequence for process development and mini-case histories within the chapters to bring alive different aspects of the process. It is completely pharmaceutical themed, encompassing all essential aspects, from route and reagent selection to manufacture of the active compound. The book is aimed at both graduates and postgraduates interested in a career in the pharmaceutical industry. It informs them about the breadth of the work carried out in chemical research and development departments, and gives them a feel for the challenges involved in the job. The book is also of value to academics who often understand the drug discovery arena, but have far less appreciation of the drug development area, and are thus unable to advise their students about the relative merits of careers in chemical development versus discovery.

Pharmaceutical Blending and Mixing

Pharmaceutical Blending and Mixing
Author: P. J. Cullen
Publisher: John Wiley & Sons
Total Pages: 508
Release: 2015-07-20
Genre: Technology & Engineering
ISBN: 0470710551

Written in four parts, this book provides a dedicated and in-depth reference for blending within the pharmaceutical manufacturing industry. It links the science of blending with regulatory requirements associated with pharmaceutical manufacture. The contributors are a combination of leading academic and industrial experts, who provide an informed and industrially relevant perspective of the topic. This is an essential book for the pharmaceutical manufacturing industry, and related academic researchers in pharmaceutical science and chemical and mechanical engineering.

Pharmaceutical Engineering Change Control

Pharmaceutical Engineering Change Control
Author: Simon G. Turner
Publisher: CRC Press
Total Pages: 200
Release: 2003-12-15
Genre: Medical
ISBN: 9781135491185

Written especially for the pharmaceutical industry professional, this book addresses each part of the life-cycle of engineering change control. It covers issues in the EU and US and describes the operational requirements and responsibilities that ensure change controls are effectively applied and recorded. Providing guidance on how to demonstrate that a change control system is working, the book includes chapters on computer validation, customization of the change process to each project's needs, and case histories and anecdotes illustrate key points and provide a basis for change control training. It gives readers a toolbox for ensuring that adequate controls are implemented.

Good Design Practices for GMP Pharmaceutical Facilities

Good Design Practices for GMP Pharmaceutical Facilities
Author: Terry Jacobs
Publisher: CRC Press
Total Pages: 674
Release: 2016-08-19
Genre: Medical
ISBN: 1315355027

This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.

Validation of Pharmaceutical Processes

Validation of Pharmaceutical Processes
Author: James P. Agalloco
Publisher: CRC Press
Total Pages: 762
Release: 2007-09-25
Genre: Medical
ISBN: 1420019791

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

Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing

Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing
Author: Hamid Mollah
Publisher: John Wiley & Sons
Total Pages: 432
Release: 2013-02-01
Genre: Science
ISBN: 1118514343

Sets forth tested and proven risk management practices in drug manufacturing Risk management is essential for safe and efficient pharmaceutical and biopharmaceutical manufacturing, control, and distribution. With this book as their guide, readers involved in all facets of drug manufacturing have a single, expertly written, and organized resource to guide them through all facets of risk management and analysis. It sets forth a solid foundation in risk management concepts and then explains how these concepts are applied to drug manufacturing. Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing features contributions from leading international experts in risk management and drug manufacturing. These contributions reflect the latest research, practices, and industry standards as well as the authors' firsthand experience. Readers can turn to the book for: Basic foundation of risk management principles, practices, and applications Tested and proven tools and methods for managing risk in pharmaceutical and biopharmaceutical product manufacturing processes Recent FDA guidelines, EU regulations, and international standards governing the application of risk management to drug manufacturing Case studies and detailed examples demonstrating the use and results of applying risk management principles to drug product manufacturing Bibliography and extensive references leading to the literature and helpful resources in the field With its unique focus on the application of risk management to biopharmaceutical and pharmaceutical manufacturing, this book is an essential resource for pharmaceutical and process engineers as well as safety and compliance professionals involved in drug manufacturing.