Author: Center for Drugs and Biologics (U.S.)Publisher:
ISBN:
Category : Asepsis and antisepsis
Languages : en
Pages : 48
Book Description
Guideline on Sterile Drug Products Produced by Aseptic Processing
Author: Center for Drugs and Biologics (U.S.)Publisher:
ISBN:
Category : Asepsis and antisepsis
Languages : en
Pages : 48
Book Description
Guideline on Sterile Drug Products Produced by Aseptic Processing
Author: Center for Drugs and Biologics (U.S.)Publisher:
ISBN:
Category : Disinfection and disinfectants
Languages : en
Pages : 38
Book Description
Guidelines on Sterile Drug Products Produced by Aseptic Processing
Author: Guideline on Sterile Drug Products Produced by Aseptic Processing
Author: Center for Drugs and Biologics (É.-U.)Publisher:
ISBN:
Category :
Languages : en
Pages : 43
Book Description
Guideline on Sterile Drug Products Produced by Aseptic Processing
Author: Food and Drug Administration, Rockville/MdPublisher:
ISBN:
Category :
Languages : en
Pages : 86
Book Description
Guidance for industry
Author: Publisher:
ISBN:
Category : Asepsis and antisepsis
Languages : en
Pages : 59
Book Description
Guidelines on Sterile Drug Products Produced by Aseptic Processing
Author: United States Food and Drug AdministrationPublisher:
ISBN:
Category :
Languages : en
Pages : 43
Book Description
Sterile Manufacturing
Author: Sam A. HoutPublisher: CRC Press
ISBN: 1000406121
Category : Technology & Engineering
Languages : en
Pages : 148
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.
Aseptic Pharmaceutical Manufacturing II
Author: Michael J. GrovesPublisher: CRC Press
ISBN: 9780935184778
Category : Medical
Languages : en
Pages : 544
Book Description
Asceptic Pharmaceutical Manufacturing II explores the sophisticated technology, developments, and applications that allow aseptic processing to approach the sterility levels achieved with terminal sterilization. Written by experts in sterile manufacturing, this book covers aseptic technology, developments, and applications and makes a valuable contribution to understanding the issues involved in aseptic manufacture. Topics include the processing of biopharmaceuticals, lyophilization, personnel training, radiopharmaceuticals, hydrogen peroxide vapor sterilization, regulatory requirements, validation, and quality systems.
Guideline on Sterile Drug Products Produced by Aspectic Processing
Author: Center for Drugs and Biologics (U.S.)Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 43
Book Description