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Author: World Health Organization
Publisher: World Health Organization
ISBN: 9241547081
Category : Business & Economics
Languages : en
Pages : 414
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Book Description
Quality assurance of pharmaceutical products is a continuing concern of WHO. Despite efforts made around the world to ensure a supply of quality and effective medicines, substandard, spurious and counterfeit products still compromise health care delivery in many countries. To respond to the global need for adequate quality assurance of pharmaceuticals, WHO's Expert Committee on Specifications for Pharmaceutical Preparations has over the years made numerous recommendations to establish standards and guidelines and to promote the effective functioning of national regulatory and control systems and the implementation of internationally agreed standards by trained personnel. Many of the relevant documents endorsed by the Committee are reproduced in this volume providing guidance covering all aspects of good manufacturing practices (GMP). Important texts on inspection are also included. Most of the material has been published separately in the Expert Committee's reports. This compendium brings it together to make it more accessible and of greater practical value to those working in faculties of pharmacy, in medicines regulation and control and in the pharmaceutical industry. This is the second updated edition of the compendium and includes texts published in 2005 and 2006 in the WHO Technical Report Series.
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9241547081
Category : Business & Economics
Languages : en
Pages : 414
Get Book Here
Book Description
Quality assurance of pharmaceutical products is a continuing concern of WHO. Despite efforts made around the world to ensure a supply of quality and effective medicines, substandard, spurious and counterfeit products still compromise health care delivery in many countries. To respond to the global need for adequate quality assurance of pharmaceuticals, WHO's Expert Committee on Specifications for Pharmaceutical Preparations has over the years made numerous recommendations to establish standards and guidelines and to promote the effective functioning of national regulatory and control systems and the implementation of internationally agreed standards by trained personnel. Many of the relevant documents endorsed by the Committee are reproduced in this volume providing guidance covering all aspects of good manufacturing practices (GMP). Important texts on inspection are also included. Most of the material has been published separately in the Expert Committee's reports. This compendium brings it together to make it more accessible and of greater practical value to those working in faculties of pharmacy, in medicines regulation and control and in the pharmaceutical industry. This is the second updated edition of the compendium and includes texts published in 2005 and 2006 in the WHO Technical Report Series.
Author: Mr. Manohar A. Potdar
Publisher: Pragati Books Pvt. Ltd.
ISBN: 9788185790596
Category : Pharmaceutical industry
Languages : en
Pages : 424
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Book Description
Author: Oliver Schmidt
Publisher: CRC Press
ISBN: 142002602X
Category : Medical
Languages : en
Pages : 392
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Book Description
When a pharmaceutical company decides to build a Quality System, it has to face the fact that there aren't any guideline that define exactly how such a system has to be built. With terms such as quality system, quality assurance, and quality management used interchangeably, even defining the system's objectives is a problem. This book provides a pr
Author: Anjaneyulu Marayya
Publisher:
ISBN: 9788188449149
Category : Business & Economics
Languages : en
Pages : 0
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Book Description
QA is the most vital function of Total Quality Management (TQM) in pharmaceutical industry. This book presents the basic concepts on various topics like QMS, GLP, GMP, Quality Audit, Statistical Quality Control and analytica methods for QA. The elements, requirement and interpretation of ISO 9000 series of QMS are presented in detail.
Author: David Roesti
Publisher: John Wiley & Sons
ISBN: 1119356075
Category : Technology & Engineering
Languages : en
Pages : 594
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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: Minal Ghante
Publisher: Springer Nature
ISBN: 9819992710
Category :
Languages : en
Pages : 525
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Book Description
Author: Dr. Santosh Karajgi , Dr. Shripad S Potadar , Dr. Sudha Patil , Mr. Ajay Shahapur , Ms. Maharani H Bhandarakavathe
Publisher: Shashwat Publication
ISBN: 936087258X
Category : Medical
Languages : en
Pages : 290
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Book Description
The Pharmacy Council of India's (PCI) revised B. Pharmacy syllabus is followed in this state-of-the-art book. The broader topics of pharmaceutical quality assurance that undergrads, postgrads, industry professionals, researchers, and students getting ready for different competitive tests need to be covered in this book's encompassing content. The writing style of this book is clear, straightforward, and uncomplicated, which sets it apart from others. For the self-evolution of learning, the book is complemented by questions in the formats of multiple choice, fill in the blank, true-false, short answer, and long answer. Additionally included are the solutions to the True-False, Fill in the Blank, and Multiple-Choice problems. Links to websites and recommended reading are provided to assist readers in staying up to date on the most recent advancements in the field of pharmaceutical quality assurance. The book can be used as the main source of instruction or as supplementary material by academicians and teachers at universities and colleges for undergraduate and graduate pharmacy courses.
Author: G Welty
Publisher: Elsevier
ISBN: 190881862X
Category : Medical
Languages : en
Pages : 374
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Book Description
Quality assurance is necessary to maintain quality and services in the pharmaceutical and life science industries. Quality assurance demonstrates that the logic and practice of problem solving can integrate both program efficacy and regulatory compliance. This title is divided into three parts; the first part discusses the process by which a problem in regulated industry is identified, for example a manufacturing deviation that leads to an adulterated drug product, and reviews the decision-making steps involved in remedying the problem. The second part delves into the staff training requirements of procedures that are thereby revised. The third part expands on this discussion by considering piloting the proposed training module, preparing assessments of trainee proficiency, evaluating the training module, including integrating rigorous evaluative designs with formative program improvement, and documenting the entire effort. Presents a comprehensive view of the field of quality assurance An approach grounded in direct experience Uses diagrams and figures to clarify analytical points
Author: R. Baird
Publisher: CRC Press
ISBN: 1135743630
Category : Science
Languages : en
Pages : 272
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Book Description
The importance of quality assurance in the production, storage and use of manufactured preparations is widely recognized. This book encapsulates the issues involved in the manufacture of non-steriles, such as creams, ointments, herbal remedies, shampoos, soaps and toiletry products (as opposed to sterile drugs and injectible products). Knowledge of the microbial limits is expanded, new standards are included, and coverage of the preservation issues of dosage forms is widened to include semi-solids and liquid preparations. This edition also contains new regulations regarding preservative efficacy testing and covers pharmacopoeial and industry regulations and guidelines. Rapid methods are also discussed, now more common in cosmetic and toiletry practice, in their pharmaceutical capacity.
Author: Steve L. Nail
Publisher: Springer Science & Business Media
ISBN: 1461505496
Category : Medical
Languages : en
Pages : 479
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Book Description
In this era of biotechnology there have been many books covering the fundamentals of recombinant DNA technology and protein chemistry. However, not many sources are available for the pharmaceutical develop ment scientist and other personnel responsible for the commercialization of the finished dosage forms of these new biopharmaceuticals and other products from biotechnology. This text will help to fill this gap. Once active biopharmaceutical molecules are candidates for clinical trial investigation and subsequent commercialization, a number of other activities must take place while research and development on these molecules continues. The active ingredient itself must be formulated into a finished dosage form that can be conveniently used by health care professionals and patients. Properties of the biopharmaceutical molecule must be clearly understood so that the appropriate finished product formulation can be developed. Finished product formulation development includes not only the chemical formulation, but also the packaging system, the manufacturing process, and appropriate control strategies to assure such good manufacturing practice attributes as safety, identity, strength, purity, and quality.
