Download or read book The GMP Handbook written by Brendan Cooper and published by Createspace Independent Publishing Platform. This book was released on 2017-07-17 with total page 150 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book The Handbook of Basic GMP Requirements written by Karyn Noemi Santoro and published by . This book was released on 2020-10-23 with total page 110 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Handbook of Basic GMP Requirements is a collection of official guidelines reported in the Eudralex website, Volume 4. Specifically, all nine chapters from Part I "Basic Requirements for Medicinal Products" are here reported.Since the pharmaceutical industry of the European Union maintains high standards of Quality Management in the development, manufacture and control of medicinal products, a regulated system is required to ensure that all medicinal products are assessed by a competent authority to ensure compliance with contemporary requirements of safety, quality and efficacy. Building a good quality system ensures not only that all products shipped around the European market are manufactured/ imported only by authorised manufacturers, but also that whose activities are regularly inspected by the competent authorities, using Quality Risk Management principles. Pharmaceutical industries must follow these guidelines and thanking to their persistent effort, they will be able to successfully manufacture a high quality, deliverable, stable medicine for human use and controlled according to quality standards appropriate to their intended use and as required by the marketing authorization.Good Manufacturing Practice guidelines aimed primarily at diminishing the risks inherent in any pharmaceutical production and not place the patients' health at risk due to inadequate safety, quality or efficacy.
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.
Download or read book Good Manufacturing Practices for Pharmaceuticals written by B. N. Cooper and published by Createspace Independent Publishing Platform. This book was released on 2017-07-26 with total page 150 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Pharmaceutical Manufacturing Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2008-03-21 with total page 1384 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.
Download or read book The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals written by José Rodríguez-Pérez and published by Quality Press. This book was released on 2014-08-15 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: This guidance book is meant as a resource to manufacturers of pharmaceuticals, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS. This book includes chapters on US current Good Manufacturing Practice (GMP); international GMP; global GMP guides and harmonization; detailed analysis of the requirements and guidances; missing subparts; what inspectors are looking for; and the price of noncompliance. It also includes an appendix with two tabulated comparisons: the first compares US, European-PIC/S, Canadian, and WHO cGMPs, while the second compares US cGMPs with effective quality system elements. The companion CD contains cGMP regulations for sterile products produced by aseptic processing; it also includes updated data of statistical enforcement by the FDA, both domestically and abroad; a detailed glossary; and dozens of FDA guidance documents as well as international regulations (EU and Canada) and harmonization documents (WHO, PIC/S, and ICH). A very comprehensive checklist for a cGMP audit that is based on risk management criteria is also included. Finally, a comprehensive GMP exam is also included.
Download or read book Good Manufacturing Practice GMP Guidelines written by Mindy J. Allport-Settle and published by Pharmalogika. This book was released on 2009-12 with total page 686 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Dietary Supplement Good Manufacturing Practices written by William J. Mead and published by CRC Press. This book was released on 2016-04-19 with total page 314 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dietary Supplement GMP is a one-stop "how-to" road map to the final dietary supplement GMP regulations recently issued by the FDA covering the manufacture, packaging, and holding of dietary supplement products.The recent regulations, outlining broad goals, intentionally avoid specifics to allow for future technological advances-leaving implementati
Download or read book Cgmp Starter Guide written by Emmet P. Tobin and published by Createspace Independent Publishing Platform. This book was released on 2016-04-16 with total page 72 pages. Available in PDF, EPUB and Kindle. Book excerpt: This concise book provides an introduction to Current Good Manufacturing Practices (aka cGMP). It introduces those who wish to work in regulated industries to GMP, highlighting key areas and practices. It is also a useful refresher for those with previous experience of cGMP.
Download or read book Food and Drink Good Manufacturing Practice written by Institute of Food Science and Technology and published by John Wiley & Sons. This book was released on 2018-10-22 with total page 389 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Good Quality Practice GQP in Pharmaceutical Manufacturing A Handbook written by Jordi Botet and published by Bentham Science Publishers. This book was released on 2015-09-28 with total page 504 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Handbook of Pharmaceutical Manufacturing Formulations written by Safaraz K. Niazi and published by CRC Press. This book was released on 2016-04-19 with total page 458 pages. Available in PDF, EPUB and Kindle. Book excerpt: No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing ster
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: How to hone your analytical skills and obtain high-quality data in the era of GMP requirements With increased regulatory pressures on the pharmaceutical industry, there is a growing need for capable analysts who can ensure appropriate scientific practices in laboratories and manufacturing sites worldwide. Based on Johnson & Johnson's acclaimed in-house training program, this practical guide provides guidance for laboratory analysts who must juggle the Food and Drug Administration's good manufacturing practices (GMP) rules with rapidly changing analytical technologies. Highly qualified industry experts walk readers step-by-step through the concepts, techniques, and tools necessary to perform analyses in an FDA-regulated environment, including clear instructions on all major analytical chemical methods-from spectroscopy to chromatography to dissolution. An ideal manual for formal training as well as an excellent self-study guide, Analytical Chemistry in a GMP Environment features: * The drug development process in the pharmaceutical industry * Uniform and consistent interpretation of GMP compliance issues * A review of the role of statistics and basic topics in analytical chemistry * An emphasis on high-performance liquid chromatographic (HPLC) methods * Chapters on detectors and quantitative analysis as well as data systems * Methods for ensuring that instruments meet standard operating procedures (SOP) requirements * Extensive appendixes for unifying terms, symbols, and procedural information
Download or read book Good Manufacturing Practices for Pharmaceuticals written by Joseph D. Nally and published by CRC Press. This book was released on 2016-04-19 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Handbook of Stability Testing in Pharmaceutical Development written by Kim Huynh-Ba and published by Springer Science & Business Media. This book was released on 2008-11-16 with total page 389 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.
Download or read book A WHO Guide to Good Manufacturing Practice GMP Requirements written by Gillian Chaloner-Larsson and published by . This book was released on 1997 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Good Clinical Laboratory and Manufacturing Practices written by Philip Carson and published by Royal Society of Chemistry. This book was released on 2007-10-31 with total page 657 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality assurance and good laboratory practices are becoming essential knowledge for professionals in all sorts of industries. This includes internal and external audit procedures for compliance with the requirements of good clinical, laboratory and manufacturing practices. Spanning chemical, cosmetic and manufacturing industries, Good Clinical, Laboratory and Manufacturing Practices: Techniques for the QA professional is aimed at: chemists, clinicians, ecotoxicologists, operation managers, pharmaceutical process managers, quality assurance officers, technicians and toxicologists. In addition sections on harmonisation of quality systems will be of value to safety, health and environment advisors. This comprehensive and high level reference will be an indispensable guide to research laboratories in academia and industry. Additional training material is also included.
