Quality Assurance Of Aseptic Preparation Services

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

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.

Aimed at students as well as professionals, this is a handbook devoted to the subject of pharmacy in the hospital setting.

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.

Concepts in Sterile Preparations and Aseptic Technique examines the current standards and best practices for sterile compounding, along with the fundamentals of aseptic technique, in a manner accessible to pharmacy and pharmacy technician students and professionals. Beginning with a review of foundational calculations and microbiological considerations, this resource reviews compatibility, stability, engineering controls, and quality assurance and control, with pertinent information from USP Chapter incorporated throughout. With engaging case studies, tips, alerts, and accompanying video tutorials, this text facilitates student learning through a robust companion website for students as well as helpful instructor resources. Video Tutorial Topics and Procedures: HLFW Cleaning, Hand Washing, Garbing, Sterile Glove, Attaching Needle to Syringe, Accessing a Vial, Equal Pressure (Milking), Equal Pressure (Reverse Milking), Removal of Air Bubbles, Ampule Breaking, Using a Filter Needle, Using a Filter Straw, Reconstituting a Vial, Uncapping and Recapping a Needle, Capping a Syringe, Priming Infusion Set, Positive Pressure, Negative Pressure, Workflow, Incompatibility, Fingertip Testing Instructor Resources: Instructor's Manual including Lab Activities and Supply List, Answer Key for Review Questions and Case Studies, PowerPoint Presentations with 375 slides, Test Bank with 189 Multiple Choice, Fill-in-the-Blank, and Short Answer questions. Student Resources: Navigate Companion Website, including: Videos, Quizzes, Interactive Glossary, Interactive Flashcards, Crossword Puzzles, Matching Exercises, Web Links Each new text includes an online access code to the Navigate Companion Website. Electronic and eBook formats may not include access to the Navigate Companion Website. Access may also be purchased separately.

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