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How To Build And Maintain An Effective Pharmaceutical Quality Management System

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How to Build and Maintain an Effective Pharmaceutical Quality Management System

How to Build and Maintain an Effective Pharmaceutical Quality Management System Book
Author : Ajaz S. Hussain
Publisher : Academic Press
Release : 2018-06
ISBN : 9780128140468
Language : En, Es, Fr & De

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Book Description :

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 Book
Author : Akansha Shakya
Publisher : BFC Publications
Release : 2022-04-21
ISBN : 9355098316
Language : En, Es, Fr & De

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Book Description :

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 Book
Author : Luis Rocha-Lona,Jose Arturo Garza-Reyes,Vikas Kumar
Publisher : CRC Press
Release : 2013-06-25
ISBN : 1466565004
Language : En, Es, Fr & De

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Book Description :

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

Pharmaceutical Analysis for Small Molecules Book
Author : Behnam Davani
Publisher : John Wiley & Sons
Release : 2017-08-01
ISBN : 1119425018
Language : En, Es, Fr & De

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Book Description :

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.

Good Design Practices for GMP Pharmaceutical Facilities

Good Design Practices for GMP Pharmaceutical Facilities Book
Author : Terry Jacobs,Andrew A. Signore
Publisher : CRC Press
Release : 2016-08-19
ISBN : 1315355027
Language : En, Es, Fr & De

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Book Description :

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

Laboratory Quality Management System Book
Author : World Health Organization
Publisher : Unknown
Release : 2011
ISBN : 9789241548274
Language : En, Es, Fr & De

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Book Description :

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

Handbook of Pharmaceutical Manufacturing Formulations Book
Author : Sarfaraz K. Niazi
Publisher : CRC Press
Release : 2016-04-19
ISBN : 1420081276
Language : En, Es, Fr & De

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Book Description :

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

Pharmaceutical Computer Systems Validation

Pharmaceutical Computer Systems Validation Book
Author : Guy Wingate
Publisher : CRC Press
Release : 2016-04-19
ISBN : 1420088955
Language : En, Es, Fr & De

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Book Description :

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

Pharmaceutical Quality Systems

Pharmaceutical Quality Systems Book
Author : Oliver Schmidt
Publisher : CRC Press
Release : 2000-04-30
ISBN : 142002602X
Language : En, Es, Fr & De

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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

Handbook of Total Quality Management

Handbook of Total Quality Management Book
Author : Christian N. Madu
Publisher : Springer Science & Business Media
Release : 2012-12-06
ISBN : 1461552818
Language : En, Es, Fr & De

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Book Description :

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.

Good Manufacturing Practices for Pharmaceuticals

Good Manufacturing Practices for Pharmaceuticals Book
Author : Joseph D. Nally
Publisher : CRC Press
Release : 2016-04-19
ISBN : 1420020935
Language : En, Es, Fr & De

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Book Description :

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

Good Manufacturing Practices for Pharmaceuticals Book
Author : D. Nally Joseph
Publisher : CRC Press
Release : 2000-10-12
ISBN : 0824741935
Language : En, Es, Fr & De

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Book Description :

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

Quality Assurance of Pharmaceuticals Book
Author : World Health Organization
Publisher : World Health Organization
Release : 2007
ISBN : 9241547081
Language : En, Es, Fr & De

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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.

Dictionary of Occupational Titles

Dictionary of Occupational Titles Book
Author : Anonim
Publisher : Unknown
Release : 1991
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

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

Global Pediatric Development of Drugs Biologics and Medical Devices

Global Pediatric Development of Drugs  Biologics  and Medical Devices Book
Author : Jocelyn Jennings,Linda McBride
Publisher : Unknown
Release : 2021-11-26
ISBN : 9781947493735
Language : En, Es, Fr & De

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Book Description :

Download Global Pediatric Development of Drugs Biologics and Medical Devices book written by Jocelyn Jennings,Linda McBride, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Pharmaceutical Suspensions

Pharmaceutical Suspensions Book
Author : Alok K. Kulshreshtha,Onkar N. Singh,G. Michael Wall
Publisher : Springer Science & Business Media
Release : 2009-11-05
ISBN : 1441910875
Language : En, Es, Fr & De

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Book Description :

The suspension dosage form has long been used for poorly soluble active ingre- ents for various therapeutic indications. Development of stable suspensions over the shelf life of the drug product continues to be a challenge on many fronts. A good understanding of the fundamentals of disperse systems is essential in the development of a suitable pharmaceutical suspension. The development of a s- pension dosage form follows a very complicated path. The selection of the proper excipients (surfactants, viscosity imparting agents etc.) is important. The particle size distribution in the finished drug product dosage form is a critical parameter that significantly impacts the bioavailability and pharmacokinetics of the product. Appropriate analytical methodologies and instruments (chromatographs, visco- ters, particle size analyzers, etc.) must be utilized to properly characterize the s- pension formulation. The development process continues with a successful scale-up of the manufacturing process. Regulatory agencies around the world require cli- cal trials to establish the safety and efficacy of the drug product. All of this devel- ment work should culminate into a regulatory filing in accordance with the regulatory guidelines. Pharmaceutical Suspensions, From Formulation Development to Manufacturing, in its organization, follows the development approach used widely in the pharmaceutical industry. The primary focus of this book is on the classical disperse system – poorly soluble active pharmaceutical ingredients s- pended in a suitable vehicle.

Achieving Customer Experience Excellence through a Quality Management System

Achieving Customer Experience Excellence through a Quality Management System Book
Author : Alka Jarvis,Luis Morales,Ulka Ranadive
Publisher : Quality Press
Release : 2016-07-08
ISBN : 0873899350
Language : En, Es, Fr & De

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Book Description :

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.

Practical Pharmaceutical Engineering

Practical Pharmaceutical Engineering Book
Author : Gary Prager
Publisher : John Wiley & Sons
Release : 2018-11-28
ISBN : 1119418844
Language : En, Es, Fr & De

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Book Description :

A practical guide to all key the elements of pharmaceuticals and biotech manufacturing and design Engineers working in the pharmaceutical and biotech industries are routinely called upon to handle operational issues outside of their fields of expertise. Traditionally the competencies required to fulfill those tasks were achieved piecemeal, through years of self-teaching and on-the-job experience—until now. Practical Pharmaceutical Engineering provides readers with the technical information and tools needed to deal with most common engineering issues that can arise in the course of day-to-day operations of pharmaceutical/biotech research and manufacturing. Engineers working in pharma/biotech wear many hats. They are involved in the conception, design, construction, and operation of research facilities and manufacturing plants, as well as the scale-up, manufacturing, packaging, and labeling processes. They have to implement FDA regulations, validation assurance, quality control, and Good Manufacturing Practices (GMP) compliance measures, and to maintain a high level of personal and environmental safety. This book provides readers from a range of engineering specialties with a detailed blueprint and the technical knowledge needed to tackle those critical responsibilities with confidence. At minimum, after reading this book, readers will have the knowledge needed to constructively participate in contractor/user briefings. Provides pharmaceutical industry professionals with an overview of how all the parts fit together and a level of expertise that can take years of on-the-job experience to acquire Addresses topics not covered in university courses but which are crucial to working effectively in the pharma/biotech industry Fills a gap in the literature, providing important information on pharmaceutical operation issues required for meeting regulatory guidelines, plant support design, and project engineering Covers the basics of HVAC systems, water systems, electric systems, reliability, maintainability, and quality assurance, relevant to pharmaceutical engineering Practical Pharmaceutical Engineering is an indispensable “tool of the trade” for chemical engineers, mechanical engineers, and pharmaceutical engineers employed by pharmaceutical and biotech companies, engineering firms, and consulting firms. It also is a must-read for engineering students, pharmacy students, chemistry students, and others considering a career in pharmaceuticals.

Pharmaceutical Product Development

Pharmaceutical Product Development Book
Author : Vandana B. Patravale,John I. Disouza,Maharukh Rustomjee
Publisher : CRC Press
Release : 2016-05-25
ISBN : 1498730787
Language : En, Es, Fr & De

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Book Description :

Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products. Pharmaceutical Product Development equips the pharmaceutical formulation scientist with extensive and up-to-date knowledge of drug product development and covers all steps from the beginning of product conception to the final packaged form that enters the market and lifecycle management thereof. Applications of core scientific principles for product development are also thoroughly discussed in conjunction with the latest approaches involving design of experiment and quality by design with comprehensive illustrations based on practical case studies of several dosage forms. The book presents pharmaceutical product development information in an easy-to-read mode with simplified theories, case studies and guidelines for students, academicians and professionals in the pharmaceutical industry. It is an invaluable resource and hands-on guide covering managerial, regulatory and practical aspects of pharmaceutical product lifecycle management.

Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy

Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy Book
Author : Mahmoud Aljurf,John A. Snowden,Patrick Hayden,Kim H. Orchard,Eoin McGrath
Publisher : Springer Nature
Release : 2021-02-19
ISBN : 3030644928
Language : En, Es, Fr & De

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Book Description :

This open access book provides a concise yet comprehensive overview on how to build a quality management program for hematopoietic stem cell transplantation (HSCT) and cellular therapy. The text reviews all the essential steps and elements necessary for establishing a quality management program and achieving accreditation in HSCT and cellular therapy. Specific areas of focus include document development and implementation, audits and validation, performance measurement, writing a quality management plan, the accreditation process, data management, and maintaining a quality management program. Written by experts in the field, Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy: A Practical Guide is a valuable resource for physicians, healthcare professionals, and laboratory staff involved in the creation and maintenance of a state-of-the-art HSCT and cellular therapy program.