Good Manufacturing Practices  GMP  Modules for Pharmaceutical Products Book

Good Manufacturing Practices GMP Modules for Pharmaceutical Products


  • Author : Chandrasekhar Panda
  • Publisher : Pencil
  • Release Date : 2021-06-24
  • Genre: Social Science
  • Pages : 75
  • ISBN 10 : 9789354583049

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Good Manufacturing Practices GMP Modules for Pharmaceutical Products Excerpt :

This Book contains 11 Modules of Good Manufacturing Practices (GMP) for Pharmaceutical Products which will be very useful to the persons working in Pharmaceutical Industry and this can be used as a cGMP Training modules in Pharmaceutical Companies which is a basic training requirement for every employee. The Modules are Module-1 Plant Premises Module-2 Plant Equipment's Module-3 Plant Production Module-4 Plant Personnel Module-5 Plant Training, Documentation and Personnel Hygiene Module-6 Plant Quality Control Module-7 Qualification and Validation Module-8 Pharmaceutical QMS Module-9 Plant Self-Inspection and Audit Module-10 Plant Complaints and Product recall Module-11 Plant Contract Manufacturing and Contract Analysis

How to Build and Maintain an Effective Pharmaceutical Quality Management System Book

How to Build and Maintain an Effective Pharmaceutical Quality Management System


  • Author : Ajaz S. Hussain
  • Publisher : Academic Press
  • Release Date : 2018-06
  • Genre: Business & Economics
  • Pages : 316
  • ISBN 10 : 0128140461

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How to Build and Maintain an Effective Pharmaceutical Quality Management System Excerpt :

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 Book

Textbook of Quality Assurance


  • Author : Akansha Shakya
  • Publisher : BFC Publications
  • Release Date : 2022-04-21
  • Genre: Medical
  • Pages : 210
  • ISBN 10 : 9789355098313

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Textbook of Quality Assurance Excerpt :

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 Book

Building Quality Management Systems


  • Author : Luis Rocha-Lona
  • Publisher : CRC Press
  • Release Date : 2013-06-25
  • Genre: Business & Economics
  • Pages : 202
  • ISBN 10 : 9781466565005

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Building Quality Management Systems Excerpt :

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.

Pharmaceutical Analysis for Small Molecules Book

Pharmaceutical Analysis for Small Molecules


  • Author : Behnam Davani
  • Publisher : John Wiley & Sons
  • Release Date : 2017-08-01
  • Genre: Science
  • Pages : 256
  • ISBN 10 : 9781119425014

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Pharmaceutical Analysis for Small Molecules Excerpt :

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

Good Design Practices for GMP Pharmaceutical Facilities Book

Good Design Practices for GMP Pharmaceutical Facilities


  • Author : Terry Jacobs
  • Publisher : CRC Press
  • Release Date : 2016-08-19
  • Genre: Medical
  • Pages : 536
  • ISBN 10 : 9781315355023

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Good Design Practices for GMP Pharmaceutical Facilities Excerpt :

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.

Laboratory Quality Management System Book

Laboratory Quality Management System


  • Author : World Health Organization
  • Publisher : Unknown
  • Release Date : 2011
  • Genre: Medical
  • Pages : 247
  • ISBN 10 : 9241548274

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Laboratory Quality Management System Excerpt :

Achieving, maintaining and improving accuracy, timeliness and reliability are major challenges for health laboratories. Countries worldwide committed themselves to build national capacities for the detection of, and response to, public health events of international concern when they decided to engage in the International Health Regulations implementation process. Only sound management of quality in health laboratories will enable countries to produce test results that the international community will trust in cases of international emergency. This handbook was developed through collaboration between the WHO Lyon Office for National Epidemic Preparedness and Response, the United States of America Centers for Disease Control and Prevention (CDC) Division of Laboratory Systems, and the Clinical and Laboratory Standards Institute (CLSI). It is based on training sessions and modules provided by the CDC and WHO in more than 25 countries, and on guidelines for implementation of ISO 15189 in diagnostic laboratories, developed by CLSI. This handbook is intended to provide a comprehensive reference on Laboratory Quality Management System for all stakeholders in health laboratory processes, from management, to administration, to bench-work laboratorians. This handbook covers topics that are essential for quality management of a public health or clinical laboratory. They are based on both ISO 15189 and CLSI GP26-A3 documents. Each topic is discussed in a separate chapter. The chapters follow the framework developed by CLSI and are organized as the "12 Quality System Essentials".

Handbook of Pharmaceutical Manufacturing Formulations Book

Handbook of Pharmaceutical Manufacturing Formulations


  • Author : Sarfaraz K. Niazi
  • Publisher : CRC Press
  • Release Date : 2016-04-19
  • Genre: Medical
  • Pages : 369
  • ISBN 10 : 9781420081275

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Handbook of Pharmaceutical Manufacturing Formulations Excerpt :

The fourth volume in the series covers the techniques and technologies involved in the preparation of semisolid products such as ointments, creams, gels, suppositories, and special topical dosage forms. Drug manufacturers need a thorough understanding of the specific requirements that regulatory agencies impose on the formulation and efficacy deter

Handbook of Total Quality Management Book

Handbook of Total Quality Management


  • Author : Christian N. Madu
  • Publisher : Springer Science & Business Media
  • Release Date : 2012-12-06
  • Genre: Technology & Engineering
  • Pages : 801
  • ISBN 10 : 9781461552819

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Handbook of Total Quality Management Excerpt :

Quality issues are occupying an increasingly prominent position in today's global business market, with firms seeking to compete on an international level on both price and quality. Consumers are demanding higher quality standards from manufacturers and service providers, while virtually all industrialized nations have instituted quality programs to help indigenous corporations. A proliferation in nation-wide and regional quality awards such as the Baldridge award and certification to ISO 9000 series are making corporations world-wide quality-conscious and eager to implement programs of continuous improvement. To achieve competitiveness, quality practice is a necessity and this book offers an exposition of how quality can be attained. The Handbook of Total Quality Management: Explores in separate chapters new topics such as re-engineering, concurrent engineering, ISO standards, QFD, the Internet, the environment, advanced manufacturing technology and benchmarking Discusses the views of leading quality practitioners such as Derning, Juran, Ishikawa, Crosby and Taguchi throughout the book Considers important strategies for quality improvement, including initiation and performance evaluation through auditing, re-engineering, and process and design innovations. With contributions from 47 authors in 13 different countries, the Handbook of Total Quality Management is invaluable as a reference guide for anyone involved with quality management and deployment, including consultants, practitioners and engineers in the professional sector, and students and lecturers of information systems, management and industrial engineering.

Pharmaceutical Computer Systems Validation Book

Pharmaceutical Computer Systems Validation


  • Author : Guy Wingate
  • Publisher : CRC Press
  • Release Date : 2016-04-19
  • Genre: Medical
  • Pages : 798
  • ISBN 10 : 9781420088953

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Pharmaceutical Computer Systems Validation Excerpt :

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 Book
Score: 3
From 2 Ratings

Good Manufacturing Practices for Pharmaceuticals


  • Author : Joseph D. Nally
  • Publisher : CRC Press
  • Release Date : 2016-04-19
  • Genre: Medical
  • Pages : 424
  • ISBN 10 : 9781420020939

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Good Manufacturing Practices for Pharmaceuticals Excerpt :

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.

Good Manufacturing Practices for Pharmaceuticals Book
Score: 5
From 1 Ratings

Good Manufacturing Practices for Pharmaceuticals


  • Author : D. Nally Joseph
  • Publisher : CRC Press
  • Release Date : 2000-10-12
  • Genre: Medical
  • Pages : 752
  • ISBN 10 : 9780824741938

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Good Manufacturing Practices for Pharmaceuticals Excerpt :

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.

Quality Assurance of Pharmaceuticals Book
Score: 4.5
From 5 Ratings

Quality Assurance of Pharmaceuticals


  • Author : World Health Organization
  • Publisher : World Health Organization
  • Release Date : 2007
  • Genre: Medical
  • Pages : 414
  • ISBN 10 : 9789241547086

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Quality Assurance of Pharmaceuticals Excerpt :

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.

Dictionary of Occupational Titles Book

Dictionary of Occupational Titles


  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 1991
  • Genre: Occupations
  • Pages : 460
  • ISBN 10 : UOM:39015020582881

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Dictionary of Occupational Titles Excerpt :

Supplement to 3d ed. called Selected characteristics of occupations (physical demands, working conditions, training time) issued by Bureau of Employment Security.

Achieving Customer Experience Excellence through a Quality Management System Book

Achieving Customer Experience Excellence through a Quality Management System


  • Author : Alka Jarvis
  • Publisher : Quality Press
  • Release Date : 2016-07-08
  • Genre: Business & Economics
  • Pages : 256
  • ISBN 10 : 9780873899352

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Achieving Customer Experience Excellence through a Quality Management System Excerpt :

We are in what many call “The Age of the Customer.” Customers are empowered more than ever before and demand a high level of customer attention and service. Their increasing expectations and demands worldwide have forced organizations to transform themselves and prepare for the customer experience (CX) battlefield. This landmark book addresses: What customer experience really means Why it matters Whether it has any substantial business impact What your organization can do to deliver and sustain your CX efforts, and How we got to this particular point in CX history This book is the result of exhaustive research conducted to incorporate various components that affect customer experience. Based on the research results, the authors make a case for seeing CX and associated transformations as the next natural evolution of the quality management system (QMS) already in place in most companies. Using an existing QMS as the foundation for CX not only creates a more sustainable platform, but it allows for a faster and more cost effective way to enable an organization to attain world-class CX.