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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 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
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.
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.
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.
The latest updated edition of the market-leading guide to Good Manufacturing Practice (GMP) in the food and drink industry This all-new, 7th edition of Food and Drink - Good Manufacturing Practice: A Guide to its Responsible Management features a wealth of new information reflecting changes in the industry and advances in science that have occurred since the publication of the last edition back in 2013. They include topics such as: Food Safety Culture, Food Crime and Food Integrity Management Systems, Food Crime Risk Assessment including vulnerability risk assessment and Threat Analysis Critical Control Point (TACCP), Security and Countermeasures, Food Toxins, Allergens and Risk Assessment, Provenance and authenticity, Electronic and digital traceability technologies, Worker Welfare Standards; Smart Packaging, Food Donation Controls and Animal Food Supply, Safety Culture; Provenance and integrity testing and Sustainability Issues. In addition to the new topics mentioned above, Food and Drink - Good Manufacturing Practice, 7th Edition offers comprehensive coverage of information in chapters on Quality Management System; Hazard Analysis Critical Control Point (HACCP); Premises and Equipment; Cleaning and Sanitation; Product Control, Testing and Inspection; Heat Preserved Foods; Frozen Foods; Foods for Catering and Vending Operations; and much more. Comprises both general guidance and food sector-specific requirements for good manufacturing practice Incorporates all the most recent developments and changes in UK and EU law Provides a readable and accessible reference for busy managers in the food industry Food and Drink - Good Manufacturing Practice: A Guide to its Responsible Management, 7th Edition is a valuable reference for anyone in a managerial or technical capacity concerned with the manufacture, storage, and distribution of food and drink. The book is also a “must –read” for the recommended reading lists for food science, food technology and food policy undergraduate and postgraduate studies. IFST - the Institute of Food Science and Technology is the leading qualifying body for food professionals in Europe and the only professional qualifying body in the UK concerned with all aspects of food science and technology.
This title combines all of the human and veterinary Regulations, Directives and guidance for medicinal products used by the pharmaceutical industry as their main source when manufacturing and distributing medicinal products in the European Union.
FDA Regulations and Associated Guidance Documents: - Code of Federal Regulation Title 21 Overview - Part 11 Electronic Records; Electronic Signatures (21CFR§11) and Guidance for Industry - Part 26 Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community (21CFR§26) - Part 200 Drugs: General (21CFR§200) - Part 207 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs, and The National Drug Code (21CFR§207) - Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General (21CFR§210) - Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals (21CFR§211) - Part 600 Biological Products: General (21CFR§600) - Part 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices (21CFR§807) - Part 820 Quality System Regulation (21CFR§820) - Part 11, Electronic Records; Electronic Signatures - Scope and Application - Guidance for Industry and FD A Staff: Current Good Manufacturing Practice Requirements for Combination Products - Guidance for Industry: CGMP for Phase 1 Investigational Drugs - Process Validation: General Principles and Practices - PAT - A Frame work for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance - Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations - Contract Manufacturing Arrangements for Drugs: Quality Agreements - Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP - Formal Dispute Resolution: Sponsor Appeals Above the Division Level Reference Tools: - Glossaries combined in one location - GMP Keyword Index for 21CFR211 - Combined Index for all documents
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.