Author: Susan Schneipp
Publisher:
ISBN: 9781942911333
Category :
Languages : en
Pages :

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Book Description

Author: Sam A. Hout
Publisher: CRC Press
ISBN: 1000603377
Category : Medical
Languages : en
Pages : 209

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Book Description
This book provides an understanding of what is required to engineer and manufacture drug products. It bridges established concepts and provides for a new outlook by concentrating and creating new linkages in the implementation of manufacturing, quality assurance, and business practices related to drug manufacturing and healthcare products. This book fills a gap by providing a connection between drug production and regulated applications. It focuses on drug manufacturing, quality techniques in oral solid dosage, and capsule filling including equipment and critical systems, to control production and the finished products. The book offers a correlation between design strategies and a step-by-step process to ensure the reliability, safety, and efficacy of healthcare products. Fundamentals of techniques, quality by design, risk assessment, and management are covered along with a scientific method approach to continuous improvement in the usage of computerized manufacturing and dependence on information technology and control operations through data and metrics. Manufacturing and Quality Assurance of Oral Pharmaceutical Products: Processing and Safe Handling of Active Pharmaceutical Ingredients (API) is of interest to professionals and engineers in the fields of manufacturing engineering, quality assurance, reliability, business management, process, and continuous improvement, life cycle management, healthcare products manufacturing, pharmaceutical processing, and computerized manufacturing.

Author:
Publisher:
ISBN:
Category : Environmental protection
Languages : en
Pages : 116

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Book Description

Author: Sam A. Hout
Publisher: CRC Press
ISBN: 1000406121
Category : Medical
Languages : en
Pages : 148

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Book Description
This book highlights key ideas and factors to coach and guide professionals involved in learning about Sterile Manufacturing and operational requirements. It covers regulations and guidelines instituted by the FDA, ISPE, EMA, MHRA, and ICH, emphasizing good manufacturing practice and inspection requirements in the manufacturing of medicinal products. Additionally, this book provides the fundamentals of aseptic techniques, quality by design, risk assessment, and management in support of sterile operations applications. It creates a link to the implementation of business practices in drug manufacturing and healthcare and forms a correlation between design strategies including a step-by-step process to ensure reliability, safety, and efficacy of healthcare products for human and animal use. The book also provides a connection between drug production and regulated applications by offering a review of the basic elements of sterile processing, and how to remain viable with solid strategic planning. The book is a concise reference for professionals and learners in the field of sterile operations that governs primarily, pharmaceutical and medical device space, but can also extend to food and cosmetics that require clean (aseptic) manufacturing applications. It also helps compounding pharmacists and GMP inspectors and auditors.

Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309392209
Category : Science
Languages : en
Pages : 117

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Book Description
The U.S. Department of State charged the Academies with the task of producing a protocol for development of standard operating procedures (SOPs) that would serve as a complement to the Chemical Laboratory Safety and Security: A Guide to Prudent Chemical Management and be included with the other materials in the 2010 toolkit. To accomplish this task, a committee with experience and knowledge in good chemical safety and security practices in academic and industrial laboratories with awareness of international standards and regulations was formed. The hope is that this toolkit expansion product will enhance the use of the previous reference book and the accompanying toolkit, especially in developing countries where safety resources are scarce and experience of operators and end-users may be limited.

Author: Syed Imtiaz Haider
Publisher: CRC Press
ISBN: 1420009419
Category : Medical
Languages : en
Pages : 1144

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Book Description
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 evaluati

Author: Giles Johnston
Publisher:
ISBN: 9781973230076
Category :
Languages : en
Pages : 61

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Book Description
Do your SOPs help your business to improve its performance? Standard Operating Procedures, or SOPs, are an essential part of any business to ensure that quality and consistency occur like clockwork, amidst the busy-ness of day to day working.Unfortunately SOPs are often under-utilised and this short book can help you to get so much more out of your SOPs by making them part of your day-to-day management approach.Most businesses fail to use their SOPs effectively, relegating them to become a bunch of documents that get filed away, never to be looked at again!But, SOPs can be used as a tool to help you increase the performance of your business, if you use them in the right way.Whether you are new to SOPs or have come across this book as part of your lean manufacturing journey, the ideas contained in this practical guide can help your business regardless of which sector you operate in. Included in this book To help you make your SOPs an effective part of your business management approach, this book includes: A refresher on how SOPs can benefit your business. Effective ways to create your SOPs. The idea of 'writing pairs' to write evenmore effective SOPs. Creating a 'SOP map' to better use SOPs in an ongoing way. Linking your daily routines to your SOPs. Downloadable templates Also included with this book is a link to five downloadable templates that you can use immediately. The downloads include formats that you can use for your own SOPs and other documents to help you get the most out of your procedures. Download your sample now Click on the book's cover above to 'Look Inside', or download a free sample now to get started. In just a few minutes from now you could be planning how to make your SOPs a worthy business ally rather than a dormant collection of untouched documents!

Author: Jeanne Moldenhauer
Publisher: CRC Press
ISBN: 1351217003
Category : Medical
Languages : en
Pages : 244

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Book Description
This book describes various methods of decontamination and how the methods work. There is a discussion of the various cleaning and disinfection methods utilized, along with details of how to qualify these methods. It also describes new technologies that may be useful in the battle for decontamination across industries. Finally, this book provides a single resource on how one can address contamination issues for a variety of manufacturing processes and industries.

Author: Jerry Isenhour
Publisher:
ISBN: 9781548579104
Category :
Languages : en
Pages : 68

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Book Description
Standard operating procedures (SOPs) and standard operating guidelines (SOGs) are invaluable to businesses of all sizes. From a multinational corporation to a start-up, any organization can benefit from clearly written and communicated SOPs and SOGs. SOPs are so important, but writing them can seem like a daunting task. How do you convey so much information without errors or misunderstandings? Entrepreneur and business coach Jerry Isenhour understands the difficulties. He also understands the rewards a working SOP program can deliver. He has done so for his own businesses in the service, retail and manufacturing segments. He has consulted with numerous management teams to assist them in producing theirs. Now he wants to help you perfect your own SOP writing skills for your business! Isenhour uses his experience as the chief executive officer along with his expertise as a business coach and consultant to share both the theory and practicalities behind SOPs. He covers how to start the SOP process, form a priority list, test the SOP, elicit team feedback, implement and distribute the SOP, evaluate its effectiveness in the workplace, troubleshoot any points of confusion, and use it to make your organization a success! With this new guide, take your company communications to the next level!

Author: Syed Imtiaz Haider
Publisher: CRC Press
ISBN: 1439826617
Category : Medical
Languages : en
Pages : 608

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Book Description
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-