How to Build and Maintain an Effective Pharmaceutical Quality Management System

How to Build and Maintain an Effective Pharmaceutical Quality Management System
Author: Ajaz S. Hussain
Publsiher: Academic Press
Total Pages: 316
Release: 2018-06
Genre: Business & Economics
ISBN: 0128140461

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How to Build and Maintain an Effective Pharmaceutical Quality Management System shares unique insights on how to improve our understanding of the human factors regarding pharmaceutical quality. It describes practical ways to improve systems thinking and ways to establish effective quality management systems. Insights are derived from the author's experience at the US Federal Drug Administration (FDA), and as a leader of the FDA's PAT and 21st Century Initiatives, and finally, as an industry executive. The book describes the fundamental concepts and explains how to improve understanding of QMS, particularly focusing on the essential role of human factors using real-life examples. Utilizes explicit case studies to illustrate ideas throughout the content Emphasizes three key areas, including management, supervisors and staff Written by a leader in the field with experience in regulatory, research and technical areas

Textbook of Quality Assurance

Textbook of Quality Assurance
Author: Akansha Shakya
Publsiher: BFC Publications
Total Pages: 210
Release: 2022-04-21
Genre: Medical
ISBN: 9789355098313

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This Quality Assurance book intended for Pharmacy students especially Third year students of Bachelor of Pharmacy. This book is also beneficial for professionals engaged in Quality Assurance Department. We have tried to emphasize on the basics of Quality Assurance. Thus complexity of the matter has been avoided with a view that complete course content has to be completed by the student in limited time period. This book present a concise and effective reference to the topics with an approach to make it interesting and convenient to remember the complicated Quality Assurance terms.

Building Quality Management Systems

Building Quality Management Systems
Author: Luis Rocha-Lona,Jose Arturo Garza-Reyes,Vikas Kumar
Publsiher: CRC Press
Total Pages: 202
Release: 2013-06-25
Genre: Business & Economics
ISBN: 9781466565005

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Quality has quickly become one of the most important decision-making factors for consumers. And although organizations invest considerable resources into building the right quality management systems (QMSs), in many instances, the adoption of such quality improvement tools are just not enough. Building Quality Management Systems: Selecting the Right Methods and Tools explains exactly what directors, practitioners, consultants, and researchers must do to make better choices in the design, implementation, and improvement of their QMSs. Based on the authors’ decades of industrial experience working on business improvement projects for multinationals looking to design or improve their QMSs, the book discusses building QMSs based on two important organizational elements: needs and resources. It begins with an overview of QMSs and systems thinking and the impact of QMSs on financial performance. Illustrating the process management approach, it reviews the most well-known business and quality improvement models, methods, and tools that support a major QMS. The authors introduce their own time-tested methodology for designing, implementing, and enhancing your own QMS. Using their proven method, you will learn how to: Implement a strategic quality plan based on your specific needs, capabilities, cost–benefits, policies, and business strategies Select the right models, methods, and tools to be adopted as part of your QMS Understand the critical success factors and implementation challenges Evaluate the level of maturity of your QMS and your implementation efforts Highlighting the importance of quality as a way of life, this book supplies the understanding you’ll need to make the right choices in the development and deployment of your QMS. With a clear focus on business performance and process management, it provides the basis for creating the quality management culture required to become a world-class organization.

Good Design Practices for GMP Pharmaceutical Facilities

Good Design Practices for GMP Pharmaceutical Facilities
Author: Terry Jacobs,Andrew A. Signore
Publsiher: CRC Press
Total Pages: 536
Release: 2016-08-19
Genre: Medical
ISBN: 9781315355023

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This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.

Pharmaceutical Analysis for Small Molecules

Pharmaceutical Analysis for Small Molecules
Author: Behnam Davani
Publsiher: John Wiley & Sons
Total Pages: 256
Release: 2017-08-01
Genre: Science
ISBN: 9781119425014

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A comprehensive introduction for scientists engaged in new drug development, analysis, and approvals Each year the pharmaceutical industry worldwide recruits thousands of recent science graduates—especially chemistry, analytical chemistry, pharmacy, and pharmaceutical majors—into its ranks. However, because of their limited background in pharmaceutical analysis most of those new recruits find making the transition from academia to industry very difficult. Designed to assist both recent graduates, as well as experienced chemists or scientists with limited regulatory, compendial or pharmaceutical analysis background, make that transition, Pharmaceutical Analysis for Small Molecules is a concise, yet comprehensive introduction to the drug development process and analysis of chemically synthesized, small molecule drugs. It features contributions by distinguished experts in the field, including editor and author, Dr. Behnam Davani, an analytical chemist with decades of technical management and teaching experience in compendial, regulatory, and industry. This book provides an introduction to pharmaceutical analysis for small molecules (non-biologics) using commonly used techniques for drug characterization and performance tests. The driving force for industry to perform pharmaceutical analyses is submission of such data and supporting documents to regulatory bodies for drug approval in order to market their products. In addition, related required supporting studies including good laboratory/documentation practices including analytical instrument qualification are highlighted in this book. Topics covered include: Drug Approval Process and Regulatory Requirements (private standards) Pharmacopeias and Compendial Approval Process (public standards) Common methods in pharmaceutical analysis (typically compendial) Common Calculations for assays and impurities and other specific tests Analytical Method Validation, Verification, Transfer Specifications including how to handle out of specification (OOS) and out of trend (OOT) Impurities including organic, inorganic, residual solvents and elemental impurities Good Documentation Practices for regulatory environment Management of Analytical Laboratories Analytical Instrument Qualifications including IQ, OQ, PQ and VQ Due to global nature of pharmaceutical industry, other topics on both regulatory (ICH) and Compendial harmonization are also highlighted. Pharmaceutical Analysis for Small Molecules is a valuable working resource for scientists directly or indirectly involved with the drug development process, including analytical chemists, pharmaceutical scientists, pharmacists, and quality control/quality assurance professionals. It also is an excellent text/reference for graduate students in analytical chemistry, pharmacy, pharmaceutical and regulatory sciences.

Pharmaceutical Computer Systems Validation

Pharmaceutical Computer Systems Validation
Author: Guy Wingate
Publsiher: CRC Press
Total Pages: 798
Release: 2016-04-19
Genre: Medical
ISBN: 9781420088953

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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 r

Good Manufacturing Practices for Pharmaceuticals

Good Manufacturing Practices for Pharmaceuticals
Author: D. Nally Joseph
Publsiher: CRC Press
Total Pages: 752
Release: 2000-10-12
Genre: Medical
ISBN: 9780824741938

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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.

Good Manufacturing Practices for Pharmaceuticals

Good Manufacturing Practices for Pharmaceuticals
Author: Joseph D. Nally
Publsiher: CRC Press
Total Pages: 424
Release: 2016-04-19
Genre: Medical
ISBN: 9781420020939

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With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.