Quality Systems And Controls For Pharmaceuticals

Author : Dipak Kumar Sarker
Publisher : John Wiley & Sons
Page : 204 pages
File Size : 40,6 Mb
Release : 2008-07-31
Category : Science
ISBN : 9780470773048

Get Book

Quality Systems and Controls for Pharmaceuticals by Dipak Kumar Sarker Pdf

Quality Systems and Control for Pharmaceuticals is an accessible overview of the highly-regulated area of pharmaceutical manufacture, the production of biomedical materials, and biomedical devices. Introducing the subject in a clear and logical manner it enables the reader to grasp the key concepts of the multidisciplinary area of control science and specifically quality control using industrial and theoretical models. Taking a multidisciplinary approach to the subject the reader is guided through key topics such as product safety which takes into account aspects of analytical science, statistics, microbiology, biotechnology, engineering, business practice and optimizing models, the law and safeguarding public health, innovation and inventiveness and contemporary best practice. The author has both industry and academic experience and many ‘best practice’ examples are included throughout the text based on his own industry experience and current practicing industrial pharmacists. This is an invaluable reference for all students of pharmacy who may have little or no familiarity with industrial practice and for those studying BSc chemistry, biomedical sciences, process analytical chemistry and MSc in Industrial Practice.

Author : World Health Organization
Publisher : World Health Organization
Page : 250 pages
File Size : 53,5 Mb
Release : 2004
Category : Business & Economics
ISBN : 9241546190

Get Book

Quality Assurance of Pharmaceuticals by World Health Organization Pdf

Over the years, the World Health Organization's Expert Committee on Specifications for Pharmaceutical Preparations, originally created to prepare The International Pharmacopoeia, has made numerous recommendations relevant to quality assurance and control for national regulatory and control systems and the implementation of international standards, but for the most part they have only been available in the annexes to various technical reports. In this second of two volumes, those annexes providing guidelines related to good manufacturing practices and to inspection of manufacturers and drug distribution channels have been gathered and revised. Annotation : 2004 Book News, Inc., Portland, OR (booknews.com).

Author : Oliver Schmidt
Publisher : CRC Press
Page : 392 pages
File Size : 55,7 Mb
Release : 2000-04-30
Category : Medical
ISBN : 9781420026023

Get Book

Pharmaceutical Quality Systems by Oliver Schmidt Pdf

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 : Minal Ghante
Publisher : Springer Nature
Page : 525 pages
File Size : 55,8 Mb
Release : 2024-06-30
Category : Electronic
ISBN : 9789819992713

Get Book

Modern Aspects of Pharmaceutical Quality Assurance by Minal Ghante Pdf

Author : José Rodríguez-Pérez
Publisher : Quality Press
Page : 246 pages
File Size : 46,6 Mb
Release : 2014-08-15
Category : Business & Economics
ISBN : 9780873898690

Get Book

The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals by José Rodríguez-Pérez Pdf

This guidance book is meant as a resource to manufacturers of pharmaceuticals, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS. This book includes chapters on US current Good Manufacturing Practice (GMP); international GMP; global GMP guides and harmonization; detailed analysis of the requirements and guidances; missing subparts; what inspectors are looking for; and the price of noncompliance. It also includes an appendix with two tabulated comparisons: the first compares US, European-PIC/S, Canadian, and WHO cGMPs, while the second compares US cGMPs with effective quality system elements. The companion CD contains cGMP regulations for sterile products produced by aseptic processing; it also includes updated data of statistical enforcement by the FDA, both domestically and abroad; a detailed glossary; and dozens of FDA guidance documents as well as international regulations (EU and Canada) and harmonization documents (WHO, PIC/S, and ICH). A very comprehensive checklist for a cGMP audit that is based on risk management criteria is also included. Finally, a comprehensive GMP exam is also included.

Author : Murray S. Cooper
Publisher : Unknown
Page : 128 pages
File Size : 48,7 Mb
Release : 1979
Category : Electronic
ISBN : OCLC:37323492

Get Book

Quality Control in the Pharmaceutical Industry by Murray S. Cooper Pdf

Author : Guy Wingate
Publisher : CRC Press
Page : 773 pages
File Size : 45,6 Mb
Release : 2016-04-19
Category : Medical
ISBN : 9781420088953

Get Book

Pharmaceutical Computer Systems Validation by Guy Wingate Pdf

Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.

Author : D. Nally Joseph
Publisher : CRC Press
Page : 752 pages
File Size : 42,5 Mb
Release : 2000-10-12
Category : Medical
ISBN : 9780824741938

Get Book

Good Manufacturing Practices for Pharmaceuticals by D. Nally Joseph Pdf

Highlighting key issues and differences among GMPs of Europe, Canada, and the WHO, this reference examines US law and governmental policy affecting domestic and multinational pharmaceutical manufacturing. The book recommend pragmatic ways to interpret and comply with FDA CGMP regulation and related criteria. They focus on geographical redistribution of manufacturing facilities, accommodation of a diversity of regulatory and statutory governance, adaptation to disparate human resources, and new growth areas of manufacture and distribution of homeopathic remedies and dietary supplements, in addition to the greater quality control required of pharmacists and other authorized dispensers.

Author : David Roesti,Marcel Goverde
Publisher : John Wiley & Sons
Page : 594 pages
File Size : 51,8 Mb
Release : 2020-01-02
Category : Technology & Engineering
ISBN : 9781119356073

Get Book

Pharmaceutical Microbiological Quality Assurance and Control by David Roesti,Marcel Goverde Pdf

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 : Walkiria S. Schlindwein,Mark Gibson
Publisher : John Wiley & Sons
Page : 375 pages
File Size : 49,8 Mb
Release : 2018-03-19
Category : Science
ISBN : 9781118895207

Get Book

Pharmaceutical Quality by Design by Walkiria S. Schlindwein,Mark Gibson Pdf

A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product. Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource: Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development Puts the focus on the industrial aspects of the new QbD approach Includes several illustrative examples of applications of QbD in practice Offers advanced specialist topics that can be systematically applied to industry Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.

Author : Sidney H. Willig,James R. Stoker
Publisher : Unknown
Page : 520 pages
File Size : 54,7 Mb
Release : 1997
Category : Business & Economics
ISBN : UOM:39015038568302

Get Book

Good Manufacturing Practices for Pharmaceuticals by Sidney H. Willig,James R. Stoker Pdf

Revised to ensure GMP compliance, this text examines US laws affecting domestic and multinational pharmaceutical manufacturing. It recommends practical ways to interpret and comply with FDA CGMP regulations while meeting the goals of a comprehensive controls system to preserve product integrity.

Author : Jordi Botet
Publisher : Bentham Science Publishers
Page : 504 pages
File Size : 52,5 Mb
Release : 2015-09-28
Category : Medical
ISBN : 9781681081144

Get Book

Good Quality Practice (GQP) in Pharmaceutical Manufacturing: A Handbook by Jordi Botet Pdf

Pharmaceutical manufacturing can be viewed as a supply chain which spans from the production and purchase of the starting and packaging materials through the manufacture of dosage forms until the safe reception of the finished product by the patient. The entire chain comprises of several processes: auditing, materials purchase (procurement), production, storage, distribution, quality control, and quality assurance. The quality standard for pharmaceutical production is ‘current good manufacturing practice (CGMP)’‘, which is applied within the frame of a pharmaceutical quality system (PQS). This implementation, however, requires a scientific approach and has to take into account several elements such as risk assessment, life cycle, patient protection, among other factors. Hence, pharmaceutical manufacturing is a complex subject in terms of regulation, given the technical and managerial requirements. This comprehensive handbook describes CGMP for new professionals who want to understand and apply the elements which build up pharmaceutical quality assurance. The book gives details about basic quality control requirements (such as risk management, quality hazards and management systems, documentation, clean environments, personnel training) and gives guidelines on regulatory aspects. This is an ideal handbook for undergraduates studying pharmaceutical or industrial manufacturing and supply chains as well for entrepreneurs and quality control professionals seeking to learn about CGMP standards and implementing quality assurance systems in the pharmaceutical sector.

Author : Kate McCormick,D. Wylie McVay Jr
Publisher : Routledge
Page : 288 pages
File Size : 45,5 Mb
Release : 2016-04-22
Category : Business & Economics
ISBN : 9781317081401

Get Book

Pharmaceutical Process Design and Management by Kate McCormick,D. Wylie McVay Jr Pdf

A quality product or service is the successful and profitable outcome of organising resources, as judged by the final customer. Every business unit needs processes in order to do this effectively; and all processes must be documented so that achievements can be measured and future improvements planned and implemented. Pharmaceutical Process Design and Management takes a step-wise approach to process management. It presents the various elements comprising a process (man, machine, materials, method and environment); it looks at quality control and quality assurance, tools for quality improvements and ways of structuring a process into discrete, fully accountable elements; it proposes that for processes to run successfully, all operators must be the initial problem-solvers; finally, it illustrates how, with the right tools, every problem can be broken down into solvable elements. Learn how to deploy a science and risk-based approach to pharmaceutical manufacturing, by taking a fundamental approach to process design and management and, as a consequence, keep your customers satisfied and your profits healthy.

Author : Hamid Mollah,Harold Baseman,Mike Long
Publisher : John Wiley & Sons
Page : 432 pages
File Size : 50,8 Mb
Release : 2013-03-18
Category : Science
ISBN : 9780470552346

Get Book

Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing by Hamid Mollah,Harold Baseman,Mike Long Pdf

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.

Author : Rhys Bryant
Publisher : Aster Publishing Corporation
Page : 210 pages
File Size : 55,9 Mb
Release : 1989
Category : Pharmaceutical industry
ISBN : 0943330173

Get Book

The Pharmaceutical Quality Control Handbook by Rhys Bryant Pdf