Certified Pharmaceutical Gmp Professional Handbook
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The Certified Pharmaceutical Gmp Professional Handbook Second Edition
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Author : Mark Allen Durivage
language : en
Publisher: Quality Press
Release Date : 2016-05-26
The Certified Pharmaceutical Gmp Professional Handbook Second Edition written by Mark Allen Durivage and has been published by Quality Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-05-26 with Business & Economics categories.
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.
The Certified Pharmaceutical Gmp Professional Handbook Third Edition
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Author : Mark Allen Durivage
language : en
Publisher:
Release Date : 2024-02-28
The Certified Pharmaceutical Gmp Professional Handbook Third Edition written by Mark Allen Durivage and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-02-28 with categories.
The Certified Pharmaceutical Gmp Professional Handbook
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Author : Mark Allen Durivage
language : en
Publisher: Quality Press
Release Date : 2016-05-23
The Certified Pharmaceutical Gmp Professional Handbook written by Mark Allen Durivage and has been published by Quality Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-05-23 with Technology & Engineering categories.
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.
The Gmp Handbook
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Author : Brendan Cooper
language : en
Publisher: Createspace Independent Publishing Platform
Release Date : 2017-07-17
The Gmp Handbook written by Brendan Cooper and has been published by Createspace Independent Publishing Platform this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-07-17 with categories.
CGMP, Current Good Manufacturing Practices has legal and practical implications for manufacturers of medicinal products and medical devices. The requirements to meet CGMP is legal requirement but it also ensures the patient receives products that are safe, effective and of consistent quality. The FDA, WHO, ICH, PIC/s AND Eudralex provide extensive guidance and regulations on many topics related to the manufacture of medicinal and drug products. A large body of reference materials is available to manufacturers and engineering professionals. This book brings together the key requirements of GMP and briefly examines the common themes and requirements published by the various authorities, bodies and international organisations. The book includes the following chapters: Chapter 1-Overview of Good Manufacturing Practices Chapter 2-Quality Management Chapter 3-Personnel Chapter 4-Buildings and Facilities Chapter 5-Process Equipment Chapter 6-Documentation and Records Chapter 7-Materials Management Chapter 8-Rejection and re-use of materials Chapter 9-Validation Chapter 10- Change Control Chapter 11-Complaints and recalls Page count 160. Paperback book. Large 8" x 10" format.
Practical Process Validation
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Author : Mark Allen Durivage
language : en
Publisher: Quality Press
Release Date : 2016-07-14
Practical Process Validation written by Mark Allen Durivage and has been published by Quality Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-07-14 with Business & Economics categories.
For the past decade, process validation issues ranked within the top six of Food and Drug Administration (FDA) form 483 observation findings issued each year. This poses a substantial problem for the medical device industry and is the reason why the authors wanted to write this book. The authors will share their collective knowledge: to help organizations improve patient safety and increase profitability while maintaining a state of compliance with regulations and standards. The intent of this book is to provide manufacturing quality professionals working in virtually any industry a quick, convenient, and comprehensive guide to properly conduct process validations that meet regulatory and certification requirements. It will aid quality technicians, engineers, managers, and others that need to plan, conduct, and monitor validation activities.
Pharmaceutical Vendors Approval Manual
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Author : Asif Erfan Syed
language : en
Publisher:
Release Date : 2021-12
Pharmaceutical Vendors Approval Manual written by Asif Erfan Syed and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-12 with Business & Economics categories.
"This book provides stepwise guidance on how to evaluate, audit, qualify and approve an active pharmaceutical ingredient (API) and packaging material manufacturer and supplier to enhance the GMP within the industry. The book will also be beneficial for institutions conducting pharmaceutical technology courses in terms of GMP and GLP applications"--
Analytical Testing For The Pharmaceutical Gmp Laboratory
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Author : Kim Huynh-Ba
language : en
Publisher: John Wiley & Sons
Release Date : 2022-04-19
Analytical Testing For The Pharmaceutical Gmp Laboratory written by Kim Huynh-Ba and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-04-19 with Science categories.
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.
Good Quality Practice Gqp In Pharmaceutical Manufacturing A Handbook
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Author : Jordi Botet
language : en
Publisher: Bentham Science Publishers
Release Date : 2015-09-28
Good Quality Practice Gqp In Pharmaceutical Manufacturing A Handbook written by Jordi Botet and has been published by Bentham Science Publishers this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-09-28 with Medical categories.
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.
Pharmaceutical Vendors Approval Manual
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Author : Erfan Syed Asif
language : en
Publisher: CRC Press
Release Date : 2021-12-12
Pharmaceutical Vendors Approval Manual written by Erfan Syed Asif and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-12-12 with Business & Economics categories.
This book provides stepwise guidance on how to evaluate, audit, qualify and approve an active pharmaceutical ingredient (API) and packaging material manufacturer and supplier to enhance the GMP within the industry. The book will also be beneficial for institutions conducting pharmaceutical technology courses in terms of GMP and GLP applications. The Pharmaceutical Vendors Approval Manual provides readers and front-line health care products manufacturers, R&D management and biotech laboratories all the information they need to know to develop a GMP-oriented industry with trained and skilled personnel and manufacture products that meet GMP and regulatory requirements. This book provides a simple, concise and easy to use reference tool covering basic quality concepts and the elements of vendor’s assessment, qualification and approval required by the pharmaceutical educational institutions and professional certification bodies. It is equally relevant to Quality Assurance officers, Quality Control Analysts, Quality Auditors and other personnel involved in GMP/GLP services in the company. The book will also be beneficial for the institutions conducting Pharmaceutical technology study courses in terms of GMP and GLP applications. This book provides readers and front-line health care products manufacturers, R&D management and biotech laboratories all the information they need to know to develop a GMP-oriented industry with trained and skilled personnel and manufacture products that meet GMP and regulatory requirements covers basic quality concepts and the elements of vendor’s assessment, qualification and approval required by the pharmaceutical educational institutions and professional certification bodies provides stepwise guidance on how to evaluate, audit, qualify and approve an API and packaging material manufacturer and supplier to enhance the GMP within the industry provides ready to use regulatory documentation, e.g. letter of commitment, questionnaire, SOP, etc. required for API and Packaging Materials contract Provided material can be easily tailored to incorporate changes to add in-house vendor’s qualification requirements. Erfan Syed Asif, Ph.D is a Senior Consultant at PharmEng Technology.
Developing An Iso 13485 Certified Quality Management System
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Author : Ilkka Juuso
language : en
Publisher: CRC Press
Release Date : 2022-03-20
Developing An Iso 13485 Certified Quality Management System written by Ilkka Juuso and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-03-20 with Business & Economics categories.
Developing an ISO 13485-Certified Quality Management System: An Implementation Guide for the Medical-Device Industry details the lessons learned from a real-world project focusing on building an ISO 13485:2016 Quality Management System (QMS) from scratch and then having it officially certified. It is a practical guide to building or improving your existing QMS with tried and tested solutions. The book takes a hands-on approach–first teaching the top 25 lessons to know before starting to develop a QMS and then walking you through the process of writing the quality manual and the standard operating procedures, training the staff on the QMS, organizing an internal audit, executing a management review, and finally passing the necessary external audits and obtaining certification. It helps you to progress from one task to the next and provides all the essential information to accomplish each task as quickly and efficiently as possible. It does not attempt to replicate the standard but instead drills into the standard to expose the core of each section of the standard and reorganize its contents into a practical workflow for developing, maintaining, and improving a Lean QMS. The book includes a wealth of real-world experience both from the author's personal dive into quality management, and from the experiences of other companies in the field and provides handy checklists for ensuring key documents and processes are fit for use–the emphasis here is to help ensure you have considered all relevant aspects. In addition, the book is not intended as a “cheat sheet” for the standard or as a review of the standard that only adds lengthy commentary on each of the clauses. Instead, the book fixes easy misunderstandings regarding QMS, provides insight into why the various clauses are written the way they are, and provides a great base to both understanding ISO 13485 QMS and developing your own QMS. The book is intended to serve both experts and novices audiences–it provides special insight on the most crucial and effective aspects of QMS.