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Author : European Free Trade Association
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (596 download)
Download or read book Safety Aspects of the Packaging of Pharmaceutical Products written by European Free Trade Association and published by . This book was released on 1983 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : European Free Trade Association. Secretariat
Publisher :
ISBN 13 :
Total Pages : 184 pages
Book Rating : 4.:/5 (42 download)
Download or read book Safety Aspects Involved in the Packaging and Labelling of Pharmaceutical Products written by European Free Trade Association. Secretariat and published by . This book was released on 1971 with total page 184 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher :
ISBN 13 :
Total Pages : 174 pages
Book Rating : 4.3/5 ( download)
Download or read book Safety Aspects Involved in the Packaging and Labelling of Pharmaceutical Products written by and published by . This book was released on 1971 with total page 174 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book SAFETY ASPECTS INVOLVED IN THE PACKAGING AND LABELLING OF PHARMACEUTICAL PRODUCTS- PROCEEDINGS OF A SEMINAR- EFTA. written by and published by . This book was released on with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products
Publisher :
ISBN 13 :
Total Pages : 164 pages
Book Rating : 4.3/5 ( download)
Download or read book Safety Aspects of the Packaging of Pharmaceutical Products written by Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products and published by . This book was released on 1984 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher :
ISBN 13 :
Total Pages : 172 pages
Book Rating : 4.:/5 (637 download)
Download or read book Safety Aspects Involved in the Packaging and Labelling of Pharmaceutical Products written by and published by . This book was released on 1971 with total page 172 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher :
ISBN 13 :
Total Pages : 154 pages
Book Rating : 4.:/5 (551 download)
Download or read book Safety Aspects of the Packaging of Pharmaceutical Products written by and published by . This book was released on 1983 with total page 154 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher :
ISBN 13 :
Total Pages : 172 pages
Book Rating : 4.:/5 (123 download)
Download or read book Safety Aspects Involved in the Packaging and Labelling of Pharmaceutical Products written by and published by . This book was released on 1971 with total page 172 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher :
ISBN 13 :
Total Pages : 172 pages
Book Rating : 4.:/5 (669 download)
Download or read book Safety Aspects Involved in the Packaging and Labelling of Pharmaceutical Products written by and published by . This book was released on 1971 with total page 172 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Dennis Jenke
Publisher : John Wiley & Sons
ISBN 13 : 1118679474
Total Pages : 400 pages
Book Rating : 4.1/5 (186 download)
Download or read book Compatibility of Pharmaceutical Solutions and Contact Materials written by Dennis Jenke and published by John Wiley & Sons. This book was released on 2013-02-26 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: Important safety aspects of compatibility for therapeutic products and their manufacturing systems, delivery devices, and containers Compatibility of Pharmaceutical Products and Contact Materials helps pharmaceutical, toxicology, analytical, and regulatory affairs professionals assess the safety of leachable and extractable chemicals associated with drug product packaging, manufacturing systems, and devices. The most comprehensive resource available, its coverage includes the strategies, tactics, and regulatory requirements for performing safety assessments, along with the means for interpreting results. Structured around a logical framework for an extractables and leachables safety assessment and closely linked to the pharmaceutical product development process, Compatibility of Pharmaceutical Products and Contact Materials directly addresses the fundamental questions of "what activities need to be performed to completely, efficiently, and effectively address the issue of product safety from an extractables and leachables perspective?" and "when do the various required activities need to be performed?" Specifically, the chapters describe: Pertinent regulations and practical ways to meet guidelines Coordinating manufacturing, storage, and delivery systems development and qualification with therapeutic product development Materials characterization and the materials screening process Component and/or system qualification (illustrated by several case studies) Performing validation/migration studies and interpreting and reporting the results Creating a product registration dossier and putting it through regulatory review Product maintenance (Change Control) from an extractables and leachables perspective Likely future developments in extractables and leachables assessment Additionally, the book's appendix provides a database, including CAS registry numbers, chemical formulas and molecular weights of extractable/leachable substances that have been reported in the chemical literature. Detailing the interconnected roles played by analytical chemistry, biological science, toxicology, and regulatory science, Compatibility of Pharmaceutical Products and Contact Materials supplies a much-needed, comprehensive resource to all those in pharmaceutical product or medical device development.
Author : Sanjivan Saini
Publisher : SANJIVAN SAINI
ISBN 13 :
Total Pages : 194 pages
Book Rating : 4./5 ( download)
Download or read book Packaging written by Sanjivan Saini and published by SANJIVAN SAINI. This book was released on with total page 194 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Packaging" by Sanjivan Saini is a comprehensive book that provides an overview of various aspects of packaging. It covers a wide range of topics related to packaging, including special packaging, safety precautions, exportable goods packaging, dangerous goods packaging, packaging for cold products, freezing products, dairy products, and packaging for hot products. Additionally, the book delves into the cost involved in packaging, its components, and various other relevant subjects. Here is a brief overview of the main units covered in the book: 1. Packaging: This unit likely introduces the fundamentals of packaging, including its purpose, importance, and various applications across industries. It may cover topics such as packaging materials, design, and functions. 2. Special Packaging: The section on special packaging explores specific packaging requirements for products with unique characteristics or needs, such as medical devices, fragile items, or hazardous substances. 3. Safety Precautions: Safety is paramount in packaging. This unit likely discusses safety measures and guidelines for packaging, including how to handle hazardous materials safely and ensure compliance with regulations. 4. Exportable Goods Packaging: Exporting goods requires careful packaging to withstand the rigors of transportation. This unit would cover the packaging considerations for goods destined for international markets. 5. Dangerous Goods Packaging: This unit delves into the packaging requirements for dangerous goods, including hazardous chemicals, radioactive materials, and other substances that require specialized containment. 6. Packaging for Cold Products, Freezing Products, Dairy Products: These sections likely focus on packaging solutions for perishable goods, such as food items that need refrigeration or freezing to maintain their quality and safety. 7. Packaging for Hot Products: In contrast to the previous unit, this section would cover packaging designed to handle products that require high-temperature resistance, such as hot food items or industrial materials. 8. Cost Involved, Component of Cost Involved: This unit would explore the economic aspects of packaging, including the various costs associated with packaging materials, design, production, and transportation. The book "Packaging" by Sanjivan Saini is likely to be a valuable resource for students, professionals, and anyone interested in gaining a comprehensive understanding of the diverse aspects of packaging. It covers a wide range of topics, providing practical insights into designing effective and safe packaging solutions for different types of products and industries.
Author :
Publisher :
ISBN 13 :
Total Pages : 154 pages
Book Rating : 4.:/5 (429 download)
Download or read book Safety Aspects of the Packaging of Pharmaceutical Products written by and published by . This book was released on with total page 154 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Frank A. Paine
Publisher : Springer Science & Business Media
ISBN 13 : 1461521254
Total Pages : 221 pages
Book Rating : 4.4/5 (615 download)
Download or read book Packaging of Pharmaceuticals and Healthcare Products written by Frank A. Paine and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: As was the case with Charles Ross's Packaging of Pharmaceuticals published by the UK Institute of Packaging in 1975 it is assumed that the reader of this book already has a broad understanding of the basics of packaging. If not the Packaging Users Handbook and the Handbook of Food Packaging are recommended. The packaging needs of pharmaceuticals are different in degree only from those of other perishable products such as processed foods. Because the required action of a medication can be nullified by any deterioration in its active principles the protection required from its packaging is at least an order of magnitude greater than that needed by foods for example. Functional efficiency is therefore of prime importance. Conversely the need for the packaging to 'sell' the medication is much less, hence the graphics required need only provide the right 'image' for the product when presented for use in hospital or surgery. Even when on sale at the pharmacy the 'appeal' required is that of providing hygiene and confidence more than anything else. Thus, the textual requirements are paramount including traceability (batch numbers, date-coding etc) in case of recall; while striking appearance to attract customer attention is in lower key. And with the increase in malicious tampering nowadays recall is more frequent.
Author :
Publisher :
ISBN 13 :
Total Pages : 24 pages
Book Rating : 4.3/5 (91 download)
Download or read book Poison Prevention Packaging written by and published by . This book was released on 1983 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Dennis Jenke
Publisher : John Wiley & Sons
ISBN 13 : 1119605105
Total Pages : 468 pages
Book Rating : 4.1/5 (196 download)
Download or read book Extractables and Leachables written by Dennis Jenke and published by John Wiley & Sons. This book was released on 2022-07-14 with total page 468 pages. Available in PDF, EPUB and Kindle. Book excerpt: EXTRACTABLES AND LEACHABLES Learn to address the safety aspects of packaged drug products and medical devices Pharmaceutical drug products and medical devices are expected to be effective and safe to use. This includes minimizing patient, user or product exposure to impurities leached from these items when the drug product is administered or when the medical device is used. Clearly, patient or user exposure to leachables must not adversely impact their health and safety. Furthermore, these impurities must not adversely affect key quality attributes of the drug product or medical device, including its manufacturability, stability, efficacy, appearance, shelf-life and conformance to standards. Extractables and leachables are derived from the drug product’s packaging, manufacturing systems and/or delivery systems or from the medical device’s materials of construction. It is imperative to understand and quantify the release of extractables from these items, the accumulation of leachables in drug products and the release of leachables from medical devices. Once extractables and leachables have been discovered, identified and quantified, their effect on the key product or device quality attributes, including safety, must be systematically and scientifically established according to recognized, rigorous and relevant regulatory and compendial standards and industry-driven best practices. In Extractables and Leachables, the chemical compatibility (including safe use) of drugs (and their containers, delivery devices and manufacturing systems) and medical devices is examined at length, focusing particularly on how trace-level extractables and leachables affect the quality and safety of a medical product and how to assess the magnitude of the effect. This is accomplished by addressing the two critical activities required to develop, register and commercialize safe, effective and affordable clinical therapies; measuring extractables and leachables (chemical characterization) and assessing their impact (for example, toxicological safety risk assessment). Each of these activities is addressed in-depth, based on the existing and developing international regulations and guidelines, current published literature and the author’s extensive personal experience. Written by a key contributor to standards, guidelines, recommended practices and the scientific literature, the book provides “insider” insights beyond those gained by merely reading the relevant texts. Given that the rapidly evolving extractables and leachables landscape, this book provides the most current and crucial information on new and forthcoming regulations and best practices. Extractables and Leachables readers will also find: A thorough summary of regulatory and compendial guidelines and the steps required to meet them A detailed and in-depth review of essential scientific principles and recommended best practices for the design, implementation, interpretation and reporting of chemical characterization studies A practical resource for optimizing the development, registration, and commercialization of safe and effective medical products A helpful tool to maximize product development and successful regulatory outcomes Extractables and Leachables is the essential reference for pharmaceutical scientists, analytical chemists, regulatory affairs professionals, engineers, and toxicologists in areas such as product research and development, product registration and approval, regulatory affairs, analytical science, quality control, and manufacturing.
Author : U.S. Consumer Product Safety Commission
Publisher :
ISBN 13 :
Total Pages : 24 pages
Book Rating : 4.3/5 (91 download)
Download or read book Consumer Deputy Program on Poison Prevention Packaging for Oral Prescription Drugs written by U.S. Consumer Product Safety Commission and published by . This book was released on 1978 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Douglas J. Ball
Publisher : John Wiley & Sons
ISBN 13 : 0470173653
Total Pages : 702 pages
Book Rating : 4.4/5 (71 download)
Download or read book Leachables and Extractables Handbook written by Douglas J. Ball and published by John Wiley & Sons. This book was released on 2012-01-24 with total page 702 pages. Available in PDF, EPUB and Kindle. Book excerpt: A practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated with inhalation drug products Packaging and device components of Orally Inhaled and Nasal Drug Products (OINDP) such as metered dose inhalers, dry powder inhalers, and nasal sprays pose potential safety risks from leachables and extractables, chemicals that can be released or migrate from these components into the drug product. Addressing the concepts, background, historical use, and development of safety thresholds and their utility for qualifying leachables and extractables in OINDP, the Leachables and Extractables Handbook takes a practical approach to familiarize readers with the recent recommendations for safety and risk assessment established through a joint effort of scientists from the FDA, academia, and industry. Coverage includes best practices for the chemical evaluation and management of leachables and extractables throughout the pharmaceutical product life cycle, as well as: Guidance for pharmaceutical professionals to qualify and risk-assess container closure system leachables and extractables in drug products Principles for defining toxicological safety thresholds that are applicable to OINDP and potentially applicable to other drug products Regulatory perspectives, along with an appendix of key terms and definitions, case studies, and sample protocols Analytical chemists, packaging and device engineers, formulation development scientists, component suppliers, regulatory affairs specialists, and toxicologists will all benefit from the wealth of information offered in this important text.
