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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

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.

Good Design Practices for GMP Pharmaceutical Facilities Second Edition

Good Design Practices for GMP Pharmaceutical Facilities  Second Edition Book
Author : Terry Jacobs,Andrew A. Signore
Publisher : CRC Press
Release : 2016-08-18
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.

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.

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

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.

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 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.

Good Manufacturing Practices GMP Modules for Pharmaceutical Products

Good Manufacturing Practices  GMP  Modules for Pharmaceutical Products Book
Author : Chandrasekhar Panda
Publisher : Pencil
Release : 2021-06-24
ISBN : 9354583040
Language : En, Es, Fr & De

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Book Description :

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

The Certified Pharmaceutical GMP Professional Handbook Second Edition

The Certified Pharmaceutical GMP Professional Handbook  Second Edition Book
Author : Mark Allen Durivage
Publisher : Quality Press
Release : 2016-05-26
ISBN : 0873899334
Language : En, Es, Fr & De

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Book Description :

The purpose of this handbook is to assist individuals for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and provide a reference for the practitioner. The second edition reflects the Body of Knowledge which was updated in 2015. This edition has also incorporated additional information including updated references. The updates reflect the current trends and expectations of the evolving pharmaceutical industry driven by consumer expectations and regulatory oversight. This handbook covers compliance with good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, and combination devices, as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients), and packaging and labeling operations.

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.

The Book of Chinese Medicine Volume 2

The Book of Chinese Medicine  Volume 2 Book
Author : Henry H. Sun,Jingyan Meng,Kaijing Yan
Publisher : Cambridge Scholars Publishing
Release : 2020-11-17
ISBN : 1527562352
Language : En, Es, Fr & De

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Book Description :

This second volume offers numerous approaches to using Chinese medicine for the prevention and treatment of various diseases in medical practice. It brings the concepts and theories learned in the first volume and applies them in clinical settings with real patient examples. It goes over the four natures and five flavors of herbal drugs, and covers the different techniques of acupuncture. The book considers how the advancements in modern technology have shaped Traditional Chinese Medicine (TCM), and discusses the revolutionary innovations that are occurring in the Chinese medicine industry today and how they will shape the future.

A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry

A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry Book
Author : Nuala Calnan,Martin J Lipa,Paige E. Kane,Jose C. Menezes
Publisher : CRC Press
Release : 2017-06-26
ISBN : 1315351366
Language : En, Es, Fr & De

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Book Description :

This book addresses the rapidly emerging field of Knowledge Management in the pharmaceutical, medical devices and medical diagnostics industries. In particular, it explores the role that Knowledge Management can play in ensuring the delivery of safe and effective products to patients. The book also provides good practice examples of how the effective use of an organisation’s knowledge assets can provide a path towards business excellence.

Process Architecture in Biomanufacturing Facility Design

Process Architecture in Biomanufacturing Facility Design Book
Author : Jeffery Odum,Michael C. Flickinger
Publisher : John Wiley & Sons
Release : 2017-11-03
ISBN : 1119369177
Language : En, Es, Fr & De

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Book Description :

Essential information for architects, designers, engineers, equipment suppliers, and other professionals who are working in or entering the biopharmaceutical manufacturing field Biomanufacturing facilities that are designed and built today are radically different than in the past. The vital information and knowledge needed to design and construct these increasingly sophisticated biopharmaceutical manufacturing facilities is difficult to find in published literature—and it’s rarely taught in architecture or design schools. This is the first book for architects and designers that fills this void. Process Architecture in Biomanufacturing Facility Design provides information on design principles of biopharmaceutical manufacturing facilities that support emerging innovative processes and technologies, use state-of-the-art equipment, are energy efficient and sustainable, and meet regulatory requirements. Relying on their many years of hands-on design and operations experience, the authors emphasize concepts and practical approaches toward design, construction, and operation of biomanufacturing facilities, including product-process-facility relationships, closed systems and single use equipment, aseptic manufacturing considerations, design of biocontainment facility and process based laboratory, and sustainability considerations, as well as an outlook on the facility of the future. Provides guidelines for meeting licensing and regulatory requirements for biomanufacturing facilities in the U.S.A and WHO—especially in emerging global markets in India, China, Latin America, and the Asia/Pacific regions Focuses on innovative design and equipment, to speed construction and time to market, increase energy efficiency, and reduce footprint, construction and operational costs, as well as the financial risks associated with construction of a new facility prior to the approval of the manufactured products by regulatory agencies Includes many diagrams that clarify the design approach Process Architecture in Biomanufacturing Facility Design is an ideal text for professionals involved in the design of facilities for manufacturing of biopharmaceuticals and vaccines, biotechnology, and life-science industry, including architects and designers of industrial facilities, construction, equipment vendors, and mechanical engineers. It is also recommended for university instructors, advanced undergraduates, and graduate students in architecture, industrial engineering, mechanical engineering, industrial design, and industrial interior design.

Good Quality Practice GQP in Pharmaceutical Manufacturing A Handbook

Good Quality Practice  GQP  in Pharmaceutical Manufacturing  A Handbook Book
Author : Jordi Botet
Publisher : Bentham Science Publishers
Release : 2015-09-28
ISBN : 1681081148
Language : En, Es, Fr & De

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Book Description :

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.

Promising Pharmaceuticals

Promising Pharmaceuticals Book
Author : Purusotam Basnet
Publisher : BoD – Books on Demand
Release : 2012-05-23
ISBN : 9535106317
Language : En, Es, Fr & De

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Book Description :

From the dawn of civilization, humans have been dreaming of happy, healthy and long-life. Our life expectancy is twice longer than 100 years ago. We know more about the diseases. Therefore we have developed new drugs to fight against them. The demand for drugs was so high that we developed Pharma industries. Although Pharma industries took responsibility of producing the needed drugs and gave us a quality of life, misuse of drugs brought further complication. Therefore, discovery, production, distribution, and the phase of administration of patients' quality assurance has to be controlled with a technological procedure and tight regulations to make the system as effective as possible for the benefit of human health. Our book provides selected but vital information on the sources, tools, technologies and regulations regarding the current status of medicine development.

Effectiveness of VA Pharmacy Drug Controls and VA Prescription Form Controls

Effectiveness of VA Pharmacy Drug Controls and VA Prescription Form Controls Book
Author : United States,United States. Congress. House. Committee on Veterans' Affairs. Subcommittee on Oversight and Investigations
Publisher : Unknown
Release : 1992
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Effectiveness of VA Pharmacy Drug Controls and VA Prescription Form Controls book written by United States,United States. Congress. House. Committee on Veterans' Affairs. Subcommittee on Oversight and Investigations, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Biosimilars and Interchangeable Biologics

Biosimilars and Interchangeable Biologics Book
Author : Sarfaraz K. Niazi
Publisher : CRC Press
Release : 2018-10-30
ISBN : 1351231308
Language : En, Es, Fr & De

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Book Description :

What’s the Deal with Biosimilars? Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development. Part of a two-volume set that covers varying aspects of biosimilars, Biosimilars and Interchangeable Biologics: Strategic Elements explores the strategic planning side of biosimilar drugs and targets issues surrounding biosimilars that are linked to legal matters. This includes principal patents and intellectual property, regulatory pathways, and concerns about affordability on a global scale. It addresses the complexity of biosimilar products, and it discusses the utilization of biosimilars and related biological drugs in expanding world markets. Of specific interest to practitioners, researchers, and scientists in the biopharmaceutical industry, this volume examines the science, technology, finance, legality, ethics, and politics of biosimilar drugs. It considers strategic planning elements that include an overall understanding of the history and the current status of the art and science of biosimilars, and it provides detailed descriptions of the legal, regulatory, and commercial characteristics. The book also presents a global strategy on how to build, take to market, and manage the next generation of biosimilars throughout their life cycle.

Pharmaceutical Quality Assurance

Pharmaceutical Quality Assurance Book
Author : Mr. Manohar A. Potdar
Publisher : Pragati Books Pvt. Ltd.
Release : 2006
ISBN : 9788185790596
Language : En, Es, Fr & De

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Book Description :

Download Pharmaceutical Quality Assurance book written by Mr. Manohar A. Potdar, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Good Manufacturing Practices for Pharmaceuticals Seventh Edition

Good Manufacturing Practices for Pharmaceuticals  Seventh Edition Book
Author : Graham P. Bunn
Publisher : CRC Press
Release : 2019-02-04
ISBN : 1498732070
Language : En, Es, Fr & De

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Book Description :

This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends.