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Author: Vinay Bhatt Publisher: CRC Press ISBN: 1482230976 Category : Medical Languages : en Pages : 524
Book Description
Written by twenty-eight experts, filled with recommendations that can immediately be put into action, this book provides the strategies and tactics required to link and harmonize manufacturing processes with GMP to achieve optimum operability and cost-effective regulatory compliance. Drawn from name brand and generic companies and regulatory and contract organizations across the globe, the contributing authors bring readers a combined 450+ years of hands-on experience. They offer thought-provoking questions to help readers diagnose their company's challenges, needs, and available options, all with the single purpose of achieving their ultimate goals: quality, high productivity, and profitability.
Author: Vinay Bhatt Publisher: CRC Press ISBN: 1482230976 Category : Medical Languages : en Pages : 524
Book Description
Written by twenty-eight experts, filled with recommendations that can immediately be put into action, this book provides the strategies and tactics required to link and harmonize manufacturing processes with GMP to achieve optimum operability and cost-effective regulatory compliance. Drawn from name brand and generic companies and regulatory and contract organizations across the globe, the contributing authors bring readers a combined 450+ years of hands-on experience. They offer thought-provoking questions to help readers diagnose their company's challenges, needs, and available options, all with the single purpose of achieving their ultimate goals: quality, high productivity, and profitability.
Author: Vinay Bhatt Publisher: CRC Press ISBN: 9781574910773 Category : Medical Languages : en Pages : 528
Book Description
Written by twenty-eight experts, filled with recommendations that can immediately be put into action, this book provides the strategies and tactics required to link and harmonize manufacturing processes with GMP to achieve optimum operability and cost-effective regulatory compliance. Drawn from name brand and generic companies and regulatory and contract organizations across the globe, the contributing authors bring readers a combined 450+ years of hands-on experience. They offer thought-provoking questions to help readers diagnose their company's challenges, needs, and available options, all with the single purpose of achieving their ultimate goals: quality, high productivity, and profitability.
Author: Brendan Cooper Publisher: Createspace Independent Publishing Platform ISBN: 9781548370251 Category : Languages : en Pages : 150
Book Description
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.
Author: John Sharp Publisher: CRC Press ISBN: 9780367393779 Category : Languages : en Pages : 520
Book Description
With over twenty different official regulatory statements worldwide on Good Manufacturing Practice (GMP) for pharmaceutical, drug, or medicinal products, two stand out as being the most influential and most frequently referenced. Bridging the gap between U.S. regulations and European Good Manufacturing Practice guidelines, Good Pharmaceutical Manufacturing Practice: Rationale and Compliance gleans the most important substance from the U.S. Current Good Manufacturing Practice, parts 210 and 211 (US cGMPs, 2002) and the European Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (EU GMP guide, 2002). The author uses his 40+ years of experience in technical management, production, quality assurance, and distribution within the pharmaceutical industry, offering a hands-on guide to better understand and implement optimal pharmaceutical practices. This book also compares the principle requirements of GMP, and explores the reasoning behind these requirements and ways to comply with them. Relevant topics include personnel, documentation, premises and equipment, production, quality control, self-inspection, recalls, and more. This is an essential guidebook for those who wish to expand their pharmaceutical business in any international capacity.
Author: D. Nally Joseph Publisher: CRC Press ISBN: 0824741935 Category : Medical Languages : en Pages : 752
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.
Author: Sidney H. Willig Publisher: ISBN: Category : Business & Economics Languages : en Pages : 520
Book Description
Revised to ensure GMP compliance, this text examines US laws affecting domestic and multinational pharmaceutical manufacturing. It recommends practical ways to interpret and comply with FDA CGMP regulations while meeting the goals of a comprehensive controls system to preserve product integrity.
Author: Joseph D. Nally Publisher: CRC Press ISBN: 1420020935 Category : Medical Languages : en Pages : 418
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.
Author: Beverly White Publisher: Independently Published ISBN: Category : Science Languages : en Pages : 0
Book Description
Good Manufacturing Practice (GMP) is a legal and regulatory necessity that helps to ensure the quality, safety, and efficacy of pharmaceutical products and medical devices . At its core, GMP is a set of regulations, codes, and guidelines recommended by competent authorities, agencies and professional bodies that control or contribute to the authorization and licensing of the manufacture and sale of pharmaceuticals and medical devices. These principles are designed to minimize the risks involved in pharmaceutical production that cannot be eliminated through testing the final product alone. GMP covers all aspects of production, from the raw materials, premises, and equipment to the training and hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made. This framework not only benefits the health and safety of the public but also enhances the efficiency and quality of the pharmaceutical manufacturing process. Compliance with GMP is a mandatory aspect in pharmaceutical manufacturing, and adherence is closely monitored through inspections and audits by regulatory authorities. ### Introduction to GMP for Medical Devices Good Manufacturing Practice (GMP) for medical devices is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any medical device production that cannot be eliminated through final product testing. GMP encompasses all aspects of the manufacturing process, including the training and qualifications of staff, cleanliness of the facilities, and the handling and documentation of materials. The goal of GMP in the context of medical devices is to prevent harm to the user. Regulations and guidelines under GMP for medical devices are internationally recognized and are specifically tailored to meet the unique requirements of this sector. They ensure that medical devices are manufactured consistently and are safe for their intended use. This includes implementing a quality management system (QMS), which encompasses the organizational structure, procedures, processes, and resources needed to implement quality management. In the medical device industry, adherence to GMP standards is rigorously enforced by health authorities and regulatory agencies worldwide. Companies that fail to comply with these regulations can face severe penalties, including product recalls, bans, and legal action. For manufacturers, compliance is not just about meeting regulatory requirements; it's about ensuring the trust of healthcare professionals and patients in the safety and effectiveness of their products. 1.0 Quality Management Systems 2.0 Personnel, Buildings And Facilities 3.0 Materials Management 4.0 Validation 5.0 Complaints And Recalls 6.0 Risk Management 7.0 Data Integrity And Principles Of Compliance 8.0 Facilities, Utilities And Cleanrooms
Author: Shayne Cox Gad Publisher: John Wiley & Sons ISBN: 0470259825 Category : Science Languages : en Pages : 857
Book Description
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.
Author: United States. Bureau of Medical Devices. Division of Compliance Programs Publisher: ISBN: Category : Medical instruments and apparatus Languages : en Pages : 172
Author: Vinay Bhatt
Author: Vinay Bhatt
Author: Vinay Bhatt
Author: Brendan Cooper
Author: John Sharp
Author: D. Nally Joseph
Author: Sidney H. Willig
Author: Joseph D. Nally
Author: Beverly White
Author: Shayne Cox Gad
Author: United States. Bureau of Medical Devices. Division of Compliance Programs