Quality Assurance Of Aseptic Preparation Services
Download Quality Assurance Of Aseptic Preparation Services full books in PDF, epub, and Kindle. Read online free Quality Assurance Of Aseptic Preparation Services ebook anywhere anytime directly on your device. Fast Download speed and no annoying ads. We cannot guarantee that every ebooks is available!
Author | : Alison M. Beaney |
Publisher | : |
Total Pages | : 0 |
Release | : 2016 |
Genre | : Asepsis and antisepsis |
ISBN | : 9780857113078 |
Quality Assurance of Aseptic Preparation Services Standards Handbook (also known as the Yellow Guide) provides standards for unlicensed aseptic preparation in the UK, as well as practical information to aid implementation of the standards. The handbook delivers essential standards in a practical way and in a format that will be useful for pharmacy management, staff working in aseptic preparation units and those whose role it is to audit the services. The accompanying support resources help with understanding the complexities of relevant topics including microbiology, radiopharmaceuticals, advanced therapy medicinal products, technical (quality) agreements and capacity planning. All the standards have been revised and updated for this 5th edition. The text is produced on behalf of the Royal Pharmaceutical Society (RPS) and the NHS Pharmaceutical Quality Assurance Committee. New in this edition: Replaces the 4th edition standards and forms the basis for an ongoing audit program in the NHS Many new and revised standards Greater emphasis on Pharmaceutical Quality Systems; the responsibilities of pharmacy management, Chief Pharmacists (or equivalent), has been expanded in line with developments in Good Manufacturing Practice Reformatted into 2 parts: standards and support resources. This is a new collaboration between the RPS and NHS. Since the previous edition the RPS has become the professional body for pharmacists and pharmaceutical scientists. RPS launched these standards as part of a library of professional standards and a programme of work to create standards for all areas of pharmacy. The Handbook is essential for pharmacists, hospital pharmacy management and technical services teams, and auditors of unlicensed NHS hospital pharmacy aseptic preparation services in the UK, pharmacists and regulators. The text is used to inform standards used in several other countries.
Author | : Alison M. Beaney |
Publisher | : Pharmaceutical Press |
Total Pages | : 172 |
Release | : 2006 |
Genre | : Medical |
ISBN | : 9780853696155 |
A detailed guide to the operation and quality assurance of UK hospital aseptic preparation services This new edition of Quality Assurance of Aseptic Preparation Services provides information and up to date national guidance on unlicensed aseptic preparation. Although it is primarily intended for the use of non-licensed UK hospital pharmacies, it will also be of use in licensed units and other countries and institutions. Aseptic services include the preparation of parenteral nutrition solutions (PN), cytotoxics, radiopharmaceuticals, additives for parenteral administration and intrathecals Since the publication of the Breckenridge report in 1976, which recommended that drug additions to intravenous (IV) infusions should be made in hospital pharmacy departments and not on wards, there has been a substantial increase in hospital pharmacy departments providing aseptic preparation services
Author | : E. Clyde Buchanan |
Publisher | : ASHP |
Total Pages | : 497 |
Release | : 2009-02-01 |
Genre | : Medical |
ISBN | : 1585283312 |
Empower your staff to improve safety, quality and compliance with the help of new guidelines and standards. We’ve updated every chapter of this popular review of the fundamentals of preparing sterile products in hospital, home-care, and community pharmacy settings to reflect the most recent revisions to USP . Included are the latest guidelines for the compounding process, quality assurance methods, and comprehensive coverage of all aspects of the dispensing process. Comprehensive documentation for the guidelines is included in the appendices.Chapters new to this edition focus on: Gap analysis and action plans Safe use of automatic compounding devices Cleaning and disinfecting Radiopharmaceuticals as CSPs Allergen extracts as CSPs.
Author | : Martin Stephens |
Publisher | : Pharmaceutical Press |
Total Pages | : 349 |
Release | : 2011 |
Genre | : Medical |
ISBN | : 0853699003 |
Aimed at students as well as professionals, this is a handbook devoted to the subject of pharmacy in the hospital setting.
Author | : Igor Gorsky |
Publisher | : Academic Press |
Total Pages | : 300 |
Release | : 2019-11-27 |
Genre | : Medical |
ISBN | : 012809446X |
Principles of Parenteral Solution Validation: A Practical Lifecycle Approach covers all aspects involved in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, compliance developments, and regulatory considerations and trends, from process design, to divesting. As part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin, this book incorporates numerous case studies and real-world examples that address timely problems and offer solutions to the daily challenges facing practitioners in this area. - Discusses international and domestic regulatory considerations in every section - Features callout boxes that contain points-of-interest for each segment of the audience so readers can quickly find their interests and needs - Contains important topics, including risk management, the preparation and execution of properly designed studies, scale-up and technology transfer activities, problem-solving, and more
Author | : James Agalloco |
Publisher | : CRC Press |
Total Pages | : 495 |
Release | : 2016-04-19 |
Genre | : Medical |
ISBN | : 1439825440 |
The preparation of sterile products using aseptic processing is considered perhaps the most critical process in the pharmaceutical industry and has witnessed continual improvement over the last half century. New approaches that have transformed classical aseptic production methods are appearing almost daily. This book reviews emerging technologies
Author | : Peter B. Weedle |
Publisher | : Pharmaceutical Press |
Total Pages | : 385 |
Release | : 2011 |
Genre | : Law |
ISBN | : 0853698821 |
-sources of Irish law. --
Author | : Michael J. Akers |
Publisher | : CRC Press |
Total Pages | : 517 |
Release | : 2016-04-19 |
Genre | : Medical |
ISBN | : 1420020560 |
Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions, suspensions, ophthalmics and freeze dried products. This
Author | : David Roesti |
Publisher | : John Wiley & Sons |
Total Pages | : 594 |
Release | : 2020-01-02 |
Genre | : Technology & Engineering |
ISBN | : 1119356075 |
Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks
Author | : Yvonne Bouwman-Boer |
Publisher | : Springer |
Total Pages | : 873 |
Release | : 2015-08-24 |
Genre | : Medical |
ISBN | : 3319158147 |
This book contains essential knowledge on the preparation, control, logistics, dispensing and use of medicines. It features chapters written by experienced pharmacists working in hospitals and academia throughout Europe, complete with practical examples as well as information on current EU-legislation. From prescription to production, from usage instructions to procurement and the impact of medicines on the environment, the book provides step-by-step coverage that will help a wide range of readers. It offers product knowledge for all pharmacists working directly with patients and it will enable them to make the appropriate medicine available, to store medicines properly, to adapt medicines if necessary and to dispense medicines with the appropriate information to inform patients and caregivers about product care and how to maintain their quality. This basic knowledge will also be of help to industrial pharmacists to remind and focus them on the application of the medicines manufactured. The basic and practical knowledge on the design, preparation and quality management of medicines can directly be applied by the pharmacists whose main duty is production in community and hospital pharmacies and industries. Undergraduate as well as graduate pharmacy students will find knowledge and backgrounds in a fully coherent way and fully supported with examples.