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Author: J R Sharp
Publisher: Informa Healthcare
ISBN: 9781574911343
Category : Medical
Languages : en
Pages : 360
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Book Description
This newly-revised and specifically American edition of the best-selling original is the perfect introduction Good Manufacturing Practice (GMP) as it relates to manufacturing sterile products. Quality Rules in Sterile Products Manufacture is the ideal training resource for workers recently hired into the pharmaceutical, chemical, biotechnology, and bulk pharmaceutical industries. The central tool for many corporations' introductory training, retraining, and reinforcement programs, it covers all the sterile products GMP concepts required by the US FDA, the British MCA, and the European GMPs. In a simple, no-nonsense manner, the author explains the rationale of GMP and the key role played by workers in the production and packaging of pure, safe, and quality sterile products.
Author: J R Sharp
Publisher: Informa Healthcare
ISBN: 9781574911343
Category : Medical
Languages : en
Pages : 360
Get Book Here
Book Description
This newly-revised and specifically American edition of the best-selling original is the perfect introduction Good Manufacturing Practice (GMP) as it relates to manufacturing sterile products. Quality Rules in Sterile Products Manufacture is the ideal training resource for workers recently hired into the pharmaceutical, chemical, biotechnology, and bulk pharmaceutical industries. The central tool for many corporations' introductory training, retraining, and reinforcement programs, it covers all the sterile products GMP concepts required by the US FDA, the British MCA, and the European GMPs. In a simple, no-nonsense manner, the author explains the rationale of GMP and the key role played by workers in the production and packaging of pure, safe, and quality sterile products.
Author: J. R. Sharp
Publisher:
ISBN: 9780367804244
Category : MEDICAL
Languages : en
Pages : 64
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Book Description
This newly-revised and specifically American edition of the best-selling original is the perfect introduction Good Manufacturing Practice (GMP) as it relates to manufacturing sterile products. Quality Rules in Sterile Products Manufacture is the ideal training resource for workers recently hired into the pharmaceutical, chemical, biotechnology, and bulk pharmaceutical industries. The central tool for many corporations' introductory training, retraining, and reinforcement programs, it covers all the sterile products GMP concepts required by the US FDA, the British MCA, and the European GMPs. In a simple, no-nonsense manner, the author explains the rationale of GMP and the key role played by workers in the production and packaging of pure, safe, and quality sterile products.
Author: John Sharp
Publisher:
ISBN: 9780951789216
Category : Pharmaceutical industry
Languages : en
Pages : 48
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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: Sam A. Hout
Publisher: John Wiley & Sons
ISBN: 1119802326
Category : Technology & Engineering
Languages : en
Pages : 372
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Book Description
Describes the methodologies and best practices of the sterile manufacture of drug products Thoroughly trained personnel and carefully designed, operated, and maintained facilities and equipment are vital for the sterile manufacture of medicinal products using aseptic processing. Professionals in pharmaceutical and biopharmaceutical manufacturing facilities must have a clear understanding of current good manufacturing practice (cGMP) and preapproval inspection (PAI) requirements. Sterile Processing of Pharmaceutical Products: Engineering Practice, Validation, and Compliance in Regulated Environments provides up-to-date coverage of aseptic processing techniques and sterilization methods. Written by a recognized expert with more than 20 years of industry experience in aseptic manufacturing, this practical resource illustrates a comprehensive approach to sterile manufacturing engineering that can achieve drug manufacturing objectives and goals. Topics include sanitary piping and equipment, cleaning and manufacturing process validation, computerized automated systems, personal protective equipment (PPE), clean-in-place (CIP) systems, barriers and isolators, and guidelines for statistical procedure. Offering authoritative guidance on the key aspects of sterile manufacturing engineering, this volume: Covers fundamentals of aseptic techniques, quality by design, risk assessment and management, and operational requirements Addresses various regulations and guidelines instituted by the FDA, ISPE, EMA, MHRA, and ICH Provides techniques for systematic process optimization and good manufacturing practice Emphasizes the importance of attention to detail in process development and validation Features real-world examples highlighting different aspects of drug manufacturing Sterile Processing of Pharmaceutical Products: Engineering Practice, Validation, and Compliance in Regulated Environments is an indispensable reference and guide for all chemists, chemical engineers, pharmaceutical professionals and engineers, and other professionals working in pharmaceutical sciences and manufacturing.
Author: Parag Kolhe
Publisher: Springer Science & Business Media
ISBN: 1461479789
Category : Medical
Languages : en
Pages : 590
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Book Description
This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book: • Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines • Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures • Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers This book is a useful resource to scientists and researchers in both industry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development.
Author: Sharp
Publisher:
ISBN:
Category :
Languages : en
Pages : 0
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Book Description
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9240096019
Category : Medical
Languages : en
Pages : 72
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Book Description
Author: David Roesti
Publisher: John Wiley & Sons
ISBN: 1119356113
Category : Technology & Engineering
Languages : en
Pages : 592
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Book Description
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
Author: John Sharp
Publisher:
ISBN:
Category : Business & Economics
Languages : en
Pages : 536
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Book Description
This overview of quality assurance in pharmaceutical production describes the principles and practice, and discusses specific quality issues, providing a guide to both national and internatinal regulatory requirements.
