Laboratory Control System Operations In A Gmp Environment

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Laboratory Control System Operations in a GMP Environment

Author : David M. Bliesner
Publisher : John Wiley & Sons
ISBN 13 : 1119529271
Total Pages : 324 pages
Book Rating : 4.1/5 (195 download)

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Book Synopsis Laboratory Control System Operations in a GMP Environment by : David M. Bliesner

Download or read book Laboratory Control System Operations in a GMP Environment written by David M. Bliesner and published by John Wiley & Sons. This book was released on 2020-04-21 with total page 324 pages. Available in PDF, EPUB and Kindle. Book excerpt: Develop an understanding of FDA and global regulatory agency requirements for Laboratory Control System (LCS) operations In Laboratory Control System Operations in a GMP Environment, readers are given the guidance they need to implement a CGMP compliant Laboratory Control System (LCS) that fits within Global Regulatory guidelines. Using the Quality Systems Approach, regulatory agencies like the FDA and the European Medicine Agency have developed a scheme of systems for auditing pharmaceutical manufacturing facilities which includes evaluating the LCS. In this guide, readers learn the fundamental rules for operating a CGMP compliant Laboratory Control System. Designed to help leaders meet regulatory standards and operate more efficiently, the text includes chapters that cover Laboratory Equipment Qualification and Calibration, Laboratory Facilities, Method Validation and Method Transfer, Laboratory Computer Systems, Laboratory Investigations as well as Data Governance and Data Integrity. The text also includes chapters related to Laboratory Managerial and Administrative Systems, Laboratory Documentation Practices and Standard Operating Procedures and General Laboratory Compliance Practices. Additionally, a chapter outlining Stability Program operations is included in the text. In addition to these topics, it includes LCS information and tools such as: ● End of chapter templates, checklists, and LCS guidance to help you follow the required standards ● Electronic versions of each tool so users can use them outside of the text ● An In-depth understanding of what is required by the FDA and other globally significant regulatory authorities for GMP compliant systems For quality assurance professionals working within the pharmaceutical or biopharma industries, this text provides the insight and tools necessary to implement government-defined regulations.

GMP Audits in Pharmaceutical and Biotechnology Industries

Author : Mustafa Edik
Publisher : CRC Press
ISBN 13 : 1003814042
Total Pages : 474 pages
Book Rating : 4.0/5 (38 download)

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Book Synopsis GMP Audits in Pharmaceutical and Biotechnology Industries by : Mustafa Edik

Download or read book GMP Audits in Pharmaceutical and Biotechnology Industries written by Mustafa Edik and published by CRC Press. This book was released on 2024-06-28 with total page 474 pages. Available in PDF, EPUB and Kindle. Book excerpt: The fact that good manufacturing practice (GMP) audits in the pharmaceutical and biotechnology industries have to be evaluated, and with very limited resources, has created a gap in this field. The lack of trained and qualified GMP auditors is on the rise in all organizations that are required to implement FDA, EMA, MHRA, WHO, TGA, and PIC/S regulations. This volume is an essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. The author also provides useful tips and a selection of samples about GMP audits that are indispensable for professionals and health inspectors working in industry and health authorities. Features • An essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. • Anyone working in the manufacturing sector needs to be aware of GMP, be able to identify operational flaws as well as legal violations, and have a clear understanding of how to meet GMP standards. • Assists readers in understanding the importance of GMP and how they can apply each aspect in their working environment. • Covers a global regulatory landscape. • Suitable for relevant degree courses including industrial pharmaceutics and pharmaceutical biotechnology.

CleanRooms

Author :
Publisher :
ISBN 13 :
Total Pages : 52 pages
Book Rating : 4./5 ( download)

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Book Synopsis CleanRooms by :

Download or read book CleanRooms written by and published by . This book was released on 2009-03 with total page 52 pages. Available in PDF, EPUB and Kindle. Book excerpt: A central resource of technology and methods for environments where the control of contamination is critical.

Analytical Testing for the Pharmaceutical GMP Laboratory

Author : Kim Huynh-Ba
Publisher : John Wiley & Sons
ISBN 13 : 1119120918
Total Pages : 420 pages
Book Rating : 4.1/5 (191 download)

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Book Synopsis Analytical Testing for the Pharmaceutical GMP Laboratory by : Kim Huynh-Ba

Download or read book Analytical Testing for the Pharmaceutical GMP Laboratory written by Kim Huynh-Ba and published by John Wiley & Sons. This book was released on 2022-04-19 with total page 420 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides practical guidance on pharmaceutical analysis, written by leading experts with extensive industry experience Analytical Testing for the Pharmaceutical GMP Laboratory presents a thorough overview of the pharmaceutical regulations, working processes, and drug development best practices used to maintain the quality and integrity of medicines. With a focus on smaller molecular weight drug substances and products, the book provides the knowledge necessary for establishing the pharmaceutical laboratory to support Quality Systems while maintaining compliance with Good Manufacturing Practices (GMP) regulations. Concise yet comprehensive chapters contain up-to-date coverage of drug regulations, pharmaceutical analysis methodologies, control strategies, testing development and validation, method transfer, electronic data documentation, and more. Each chapter includes a table of contents, definitions of acronyms, a reference list, and ample tables and figures. Addressing the principal activities and regulatory challenges of analytical testing in the development and manufacturing of pharmaceutical drug products, this authoritative resource: Describes the structure, roles, core guidelines, and GMP regulations of the FDA and ICH. Covers the common analytical technologies used in pharmaceutical laboratories, including examples of analytical techniques used for the release and stability testing of drugs. Examines control strategies established from quality systems supported by real-world case studies. Explains the use of dissolution testing for products such as extended-release capsules, aerosols, and inhalers. Discusses good documentation and data reporting practices, stability programs, and the Laboratory Information Management System (LIMS) to maintain compliance. Includes calculations, application examples, and illustrations to assist readers in day-to-day laboratory operations. Contains practical information and templates to structure internal processes or common Standard Operating Procedures (SOPs). Analytical Testing for the Pharmaceutical GMP Laboratory is a must-have reference for both early-career and experienced pharmaceutical scientists, analytical chemists, pharmacists, and quality control professionals. It is also both a resource for GMP laboratory training programs and an excellent textbook for undergraduate and graduate courses of analytical chemistry in pharmaceutical sciences or regulatory compliance programs.

Laboratory Quality Management System

Author : World Health Organization
Publisher :
ISBN 13 : 9789241548274
Total Pages : 0 pages
Book Rating : 4.5/5 (482 download)

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Book Synopsis Laboratory Quality Management System by : World Health Organization

Download or read book Laboratory Quality Management System written by World Health Organization and published by . This book was released on 2011 with total page 0 pages. Available in PDF, EPUB and Kindle. Book 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".

Good Clinical, Laboratory and Manufacturing Practices

Author : Phillip A. Carson
Publisher : Royal Society of Chemistry
ISBN 13 : 0854048340
Total Pages : 657 pages
Book Rating : 4.8/5 (54 download)

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Book Synopsis Good Clinical, Laboratory and Manufacturing Practices by : Phillip A. Carson

Download or read book Good Clinical, Laboratory and Manufacturing Practices written by Phillip A. Carson and published by Royal Society of Chemistry. This book was released on 2007 with total page 657 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides practical advice for the quality assurance professional responsible for monitoring compliance with legal requirements and accepted standards of preclinical safety studies, clinical trials and manufacture of drugs. This book also offers a framework for integrating these standards with other quality management systems.

Good Laboratory Practice Regulations

Author : Allen F. Hirsch
Publisher : Marcel Dekker
ISBN 13 :
Total Pages : 248 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Good Laboratory Practice Regulations by : Allen F. Hirsch

Download or read book Good Laboratory Practice Regulations written by Allen F. Hirsch and published by Marcel Dekker. This book was released on 1989 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Biocontamination Control for Pharmaceuticals and Healthcare

Author : Tim Sandle
Publisher : Elsevier
ISBN 13 : 0443216010
Total Pages : 510 pages
Book Rating : 4.4/5 (432 download)

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Book Synopsis Biocontamination Control for Pharmaceuticals and Healthcare by : Tim Sandle

Download or read book Biocontamination Control for Pharmaceuticals and Healthcare written by Tim Sandle and published by Elsevier. This book was released on 2024-01-28 with total page 510 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biocontamination Control for Pharmaceuticals and Healthcare outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. The first edition of the book covered many of the aspects of the strategy, but the new official guidance signals that a roadmap is required to fully comply with its requirements. Completely updated with the newest version of the EU-GPM (EN17141) the new edition expands the coverage of quality risk management and new complete examples to help professionals bridge the gap between regulation and implementation. Biocontamination Control for Pharmaceuticals and Healthcare offers professionals in pharma quality control and related areas guidance on building a complete biocontamination strategy. - Includes the most current regulations - Contains three new chapters, including Application of Quality Risk Management and its Application in Biocontamination Control, Designing an Environmental Monitoring Programme, and Synthesis: An Anatomy of a Contamination Control Strategy - Offers practical guidance on building a complete biocontamination strategy

Analytical Chemistry in a GMP Environment

Author : James M. Miller
Publisher : Wiley-Interscience
ISBN 13 :
Total Pages : 520 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Analytical Chemistry in a GMP Environment by : James M. Miller

Download or read book Analytical Chemistry in a GMP Environment written by James M. Miller and published by Wiley-Interscience. This book was released on 2000-05 with total page 520 pages. Available in PDF, EPUB and Kindle. Book excerpt: Based on the Laboratory Analyst Training and Certification Program ... chemists from a range of pharmaceutical companies and a few academic laboratories explain how to comply with the US Food and Drug Administration's Good Manufacturing Practice rules as analytical technologies are changing rapidly .... Among the topics are the drug development process, uniform and consistent interpretation of compliance issues, the role of statistics and basic topics in analytical chemistry, and detectors and quantitative analysis. The emphasis is on high-performance liquid chromatographic methods.

Good Manufacturing Practices for Pharmaceuticals, Seventh Edition

Author : Graham P. Bunn
Publisher : CRC Press
ISBN 13 : 1351646990
Total Pages : 334 pages
Book Rating : 4.3/5 (516 download)

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Book Synopsis Good Manufacturing Practices for Pharmaceuticals, Seventh Edition by : Graham P. Bunn

Download or read book Good Manufacturing Practices for Pharmaceuticals, Seventh Edition written by Graham P. Bunn and published by CRC Press. This book was released on 2019-02-04 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Medical Product Regulatory Affairs

Author : John J. Tobin
Publisher : John Wiley & Sons
ISBN 13 : 9783527318773
Total Pages : 302 pages
Book Rating : 4.3/5 (187 download)

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Book Synopsis Medical Product Regulatory Affairs by : John J. Tobin

Download or read book Medical Product Regulatory Affairs written by John J. Tobin and published by John Wiley & Sons. This book was released on 2008-09-02 with total page 302 pages. Available in PDF, EPUB and Kindle. Book excerpt: Viel Information zum attraktiven Preis: In diesem übersichtlich strukturierten, prägnant formulierten Buch finden Sie alle wichtigen gesetzlichen Vorschriften für den internationalen Pharma- und Medizingerätemarkt. Nach einer kurzen Einführung in den Prozess der Wirkstoffentwicklung und -zulassung werden nationale Bestimmungen, EU-Recht, USA-Recht, die Vergabe von Herstell- und Vermarktungslizenzen, CDER-/CBER-Richtlinien sowie relevante Teile von GLP, GCP und GMP behandelt.

Male Infertility

Author : Jayant G. Mehta
Publisher : JP Medical Ltd
ISBN 13 : 1907816461
Total Pages : 150 pages
Book Rating : 4.9/5 (78 download)

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Book Synopsis Male Infertility by : Jayant G. Mehta

Download or read book Male Infertility written by Jayant G. Mehta and published by JP Medical Ltd. This book was released on 2014-05-19 with total page 150 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a comprehensive understanding of male infertility together with detailed and authoritative guidelines and procedures for sperm diagnosis, management and delivery.

Process Architecture in Biomanufacturing Facility Design

Author : Jeffery Odum
Publisher : John Wiley & Sons
ISBN 13 : 1119369177
Total Pages : 384 pages
Book Rating : 4.1/5 (193 download)

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Book Synopsis Process Architecture in Biomanufacturing Facility Design by : Jeffery Odum

Download or read book Process Architecture in Biomanufacturing Facility Design written by Jeffery Odum and published by John Wiley & Sons. This book was released on 2017-11-03 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Data Integrity and Data Governance

Author : R. D. McDowall
Publisher : Royal Society of Chemistry
ISBN 13 : 178801281X
Total Pages : 660 pages
Book Rating : 4.7/5 (88 download)

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Book Synopsis Data Integrity and Data Governance by : R. D. McDowall

Download or read book Data Integrity and Data Governance written by R. D. McDowall and published by Royal Society of Chemistry. This book was released on 2018-11-09 with total page 660 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides practical and detailed advice on how to implement data governance and data integrity for regulated analytical laboratories working in the pharmaceutical and allied industries.

Pharmaceutical Manufacturing Handbook

Author : Shayne Cox Gad
Publisher : John Wiley & Sons
ISBN 13 : 0470259809
Total Pages : 1386 pages
Book Rating : 4.4/5 (72 download)

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Book Synopsis Pharmaceutical Manufacturing Handbook by : Shayne Cox Gad

Download or read book Pharmaceutical Manufacturing Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2008-03-11 with total page 1386 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.

Guidance for Preparing Standard Operating Procedures (SOPs).

Author :
Publisher :
ISBN 13 :
Total Pages : 116 pages
Book Rating : 4.:/5 (31 download)

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Book Synopsis Guidance for Preparing Standard Operating Procedures (SOPs). by :

Download or read book Guidance for Preparing Standard Operating Procedures (SOPs). written by and published by . This book was released on 2001 with total page 116 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Pharmaceutical Manufacturing Handbook

Author : Shayne Cox Gad
Publisher : John Wiley & Sons
ISBN 13 : 0470259825
Total Pages : 857 pages
Book Rating : 4.4/5 (72 download)

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Book Synopsis Pharmaceutical Manufacturing Handbook by : Shayne Cox Gad

Download or read book Pharmaceutical Manufacturing Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2008-04-04 with total page 857 pages. Available in PDF, EPUB and Kindle. Book excerpt: With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.