Good Design Practices for GMP Pharmaceutical Facilities
Good Design Practices for GMP Pharmaceutical Facilities

Author: Terry Jacobs

Publisher: CRC Press

Published: 2016-08-19

Total Pages: 535

ISBN-13: 1482258919

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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.

Good Design Practices for GMP Pharmaceutical Facilities
Good Design Practices for GMP Pharmaceutical Facilities

Author: Terry Jacobs

Publisher: CRC Press

Published: 2016-08-19

Total Pages: 674

ISBN-13: 1315355027

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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.

Good Laboratory Practice Regulations
Good Laboratory Practice Regulations

Author: Sandy Weinberg

Publisher: CRC Press

Published: 2007-01-19

Total Pages: 306

ISBN-13: 0849375843

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Recent changes in the interpretation and enforcement of 21 CFR Part 11 have shifted the focus of Good Laboratory Practice (GLP) regulations to concentrate on the acceptance of electronic signatures, the archiving of data, the security of electronic documents, and the automation of laboratory procedures. This all-encompassing Fourth Edition addresse

The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals
The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals

Author: José Rodríguez-Pérez

Publisher: Quality Press

Published: 2014-08-15

Total Pages: 246

ISBN-13: 0873898699

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This guidance book is meant as a resource to manufacturers of pharmaceuticals, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS. This book includes chapters on US current Good Manufacturing Practice (GMP); international GMP; global GMP guides and harmonization; detailed analysis of the requirements and guidances; missing subparts; what inspectors are looking for; and the price of noncompliance. It also includes an appendix with two tabulated comparisons: the first compares US, European-PIC/S, Canadian, and WHO cGMPs, while the second compares US cGMPs with effective quality system elements. The companion CD contains cGMP regulations for sterile products produced by aseptic processing; it also includes updated data of statistical enforcement by the FDA, both domestically and abroad; a detailed glossary; and dozens of FDA guidance documents as well as international regulations (EU and Canada) and harmonization documents (WHO, PIC/S, and ICH). A very comprehensive checklist for a cGMP audit that is based on risk management criteria is also included. Finally, a comprehensive GMP exam is also included.

Good Manufacturing Practices for Pharmaceuticals, Seventh Edition
Good Manufacturing Practices for Pharmaceuticals, Seventh Edition

Author: Graham P. Bunn

Publisher: CRC Press

Published: 2019-02-04

Total Pages: 387

ISBN-13: 1498732070

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This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends. Key Features: Presents insight into the world of pharmaceutical quality systems Analyzes regulatory trends and expectations Includes approaches and practices used in the industry to comply with regulatory requirements Discusses recent worldwide supply chain issues Delivers valuable information to a worldwide audience regarding the current GMP practices in the industry

Pharmaceutical Microbiological Quality Assurance and Control
Pharmaceutical Microbiological Quality Assurance and Control

Author: David Roesti

Publisher: John Wiley & Sons

Published: 2020-01-02

Total Pages: 594

ISBN-13: 1119356075

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Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks

Promising Pharmaceuticals
Promising Pharmaceuticals

Author: Purusotam Basnet

Publisher: BoD – Books on Demand

Published: 2012-05-23

Total Pages: 162

ISBN-13: 9535106317

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From the dawn of civilization, humans have been dreaming of happy, healthy and long-life. Our life expectancy is twice longer than 100 years ago. We know more about the diseases. Therefore we have developed new drugs to fight against them. The demand for drugs was so high that we developed Pharma industries. Although Pharma industries took responsibility of producing the needed drugs and gave us a quality of life, misuse of drugs brought further complication. Therefore, discovery, production, distribution, and the phase of administration of patients' quality assurance has to be controlled with a technological procedure and tight regulations to make the system as effective as possible for the benefit of human health. Our book provides selected but vital information on the sources, tools, technologies and regulations regarding the current status of medicine development.

Perinatal Tissue-Derived Stem Cells
Perinatal Tissue-Derived Stem Cells

Author: Babak Arjmand

Publisher: Springer

Published: 2016-12-01

Total Pages: 246

ISBN-13: 3319464108

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This book covers several aspects of perinatal tissue-derived stem cells, from theoretical concepts to clinical applications. Topics include functions and different sources, immunomodulatory properties, translational point of view, GMP facility design and manufacturing for clinical translation, therapeutic potentials, and finally ethical considerations. The text provides a brief review of each type of perinatal stem cells and then focuses on their multi- or pluripotent properties, regenerative capacity, and future therapeutic potential in regenerative medicine. Additionally, the book discusses GMP compliance in stem cell facilities and the manufacture of stem cells for clinical translation. The chapters are authored by world-renowned experts in the perinatal stem cell field. Perinatal Tissue-Derived Stem Cells: Alternative Sources of Fetal Stem Cells, part of Springer’s Stem Cell Biology and Regenerative Medicine series, is essential reading for basic and clinical scientists, clinicians, and pharmaceutical experts working or conducting research in the fields of stem cell biology, molecular aspects of stem cell research, tissue engineering, regenerative medicine, and cellular therapy.

A Text Book of Pharmaceutics for I Year Diploma in Pharmacy
A Text Book of Pharmaceutics for I Year Diploma in Pharmacy

Author: Dr. Sowjanya Gurugubelli

Publisher: ThinkPlus Pharma Publications

Published: 2024-10-15

Total Pages: 431

ISBN-13: 8197973172

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A "Textbook of Pharmaceutics for I Year Diploma in Pharmacy" is a comprehensive guide designed to provide students with a strong foundation in pharmaceutical sciences. This book covers a wide range of topics, from the historical background of pharmacy to modern manufacturing techniques and novel drug delivery systems. Each chapter includes learning objectives, multiple-choice questions, quick summaries, and important questions to reinforce key concepts. With its focus on both theoretical knowledge and practical applications, this textbook is an essential resource for aspiring pharmacists. It offers a balanced approach to understanding the principles of pharmaceutics, quality control, and the latest advancements in the field, preparing students for successful careers in pharmacy