PDA Technical Report No. 28 (Revised 2006) PDF Download
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Author: PDA
Publisher:
ISBN: 9780939459148
Category :
Languages : en
Pages :
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Book Description
Author: PDA
Publisher:
ISBN: 9780939459148
Category :
Languages : en
Pages :
Get Book Here
Book Description
Author: PDA
Publisher:
ISBN: 9780939459186
Category :
Languages : en
Pages :
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Book Description
Author: James Agalloco
Publisher: CRC Press
ISBN: 1000436012
Category : Medical
Languages : en
Pages : 1062
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Book Description
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
Author: James P. Agalloco
Publisher:
ISBN: 9780939459155
Category :
Languages : en
Pages : 54
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Book Description
Author: PDA
Publisher:
ISBN: 9780939459117
Category :
Languages : en
Pages :
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Book Description
Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 16
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Book Description
Author: Mark Gibson
Publisher: CRC Press
ISBN: 1420073184
Category : Medical
Languages : en
Pages : 562
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Book Description
Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form reflects the mounting pressure on pharmaceutical companies to accelerate the new drug development and launch process, as well as the shift from developing small molecules to the growth of biopharmaceuticals. The book meets the ne
Author: Graham P. Bunn
Publisher: CRC Press
ISBN: 1498732070
Category : Medical
Languages : en
Pages : 371
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Book Description
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.
Author: Stephen Hall
Publisher: Butterworth-Heinemann
ISBN: 0128110384
Category : Technology & Engineering
Languages : en
Pages : 518
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Book Description
Rules of Thumb for Chemical Engineers, Sixth Edition, is the most complete guide for chemical and process engineers who need reliable and authoritative solutions to on-the-job problems. The text is comprehensively revised and updated with new data and formulas. The book helps solve process design problems quickly, accurately and safely, with hundreds of common sense techniques, shortcuts and calculations. Its concise sections detail the steps needed to answer critical design questions and challenges. The book discusses physical properties for proprietary materials, pharmaceutical and biopharmaceutical sector heuristics, process design, closed-loop heat transfer systems, heat exchangers, packed columns and structured packings. This book will help you: save time you no longer have to spend on theory or derivations; improve accuracy by exploiting well tested and accepted methods culled from industry experts; and save money by reducing reliance on consultants. The book brings together solutions, information and work-arounds from engineers in the process industry. Includes new chapters on biotechnology and filtration Incorporates additional tables with typical values and new calculations Features supporting data for selecting and specifying heat transfer equipment
Author: Hamid Mollah
Publisher: John Wiley & Sons
ISBN: 1118514343
Category : Science
Languages : en
Pages : 432
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Book Description
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.
