Quality Assurance of Aseptic Preparation Services: Standards

1 Professional Standards2016 Quality Assurance of Aseptic Preparation Services: StandardsPart A | Fifth editionEdited by Alison M Beaney D Prof, MSc, FRPharmSOn behalf of the Royal Pharmaceutical Society and the NHS Pharmaceutical Quality Assurance CommitteeQuality Assurance of Aseptic Preparation Services: StandardsFifth editionEdited by Alison M Beaney D Prof, MSc, FRPharmS Regional Quality Assurance Specialist North East and North Cumbria Chair NHS Pharmaceutical Quality Assurance Committee Visiting Professor.

2 University of behalf of the Royal Pharmaceutical Society and the NHS Pharmaceutical Quality Assurance Committee Royal Pharmaceutical Society 2016 First edition published 1993 by the Quality Control Sub-Committee of the Regional Pharmaceutical Officers Committee Second edition published 1995 by the NHS QC Committee Third edition published 2001 by the Pharmaceutical Press Fourth edition published 2006 by the Pharmaceutical Press Fifth edition published 2016 All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, without the prior written permission of the copyright right of Alison M Beaney to be identified as the editor of this work has been asserted by her in accordance with the Copyright, Designs and Patents Act, publication is intended as professional Standards and may not include all information relevant to the subject matter.

3 You should interpret all information and advice in light of your own professional knowledge and all relevant literature and guidelines. Nothing in this publication constitutes legal advice and cannot be relied upon as such. Whilst care has been taken to ensure the accuracy of content the Royal Pharmaceutical Society excludes to the fullest extent permissible by law any liability whether in contract, tort or otherwise arising from your reliance on these Standards , information and advice. CONTENTSQUALITY Assurance OF Aseptic Preparation SERVICES.

4 Standards PART A2 PREFACE 3 CHAPTER 1 INTRODUCTION 4 CHAPTER 2 DEFINITIONS / GLOSSARY OF TERMS 7 CHAPTER 3 MINIMISING RISK WITH INJECTABLE MEDICINES 18 CHAPTER 4 PRESCRIBING, CLINICAL PHARMACY AND Aseptic 24 SERVICES VERIFICATION CHAPTER 5 MANAGEMENT 32 CHAPTER 6 FORMULATION, STABILITY AND SHELF LIFE 37 CHAPTER 7 FACILITIES AND EQUIPMENT 44 CHAPTER 8 PHARMACEUTICAL Quality SYSTEM 58 CHAPTER 9 PERSONNEL, TRAINING AND COMPETENCY ASSESSMENT 68 CHAPTER 10 Aseptic PROCESSING 73C H A P T E R 11 MONITORING 80 CHAPTER 12 CLEANING, SANITISATION AND BIODECONTAMINATION 97 CHAP TER 13 STARTING MATERIALS, COMPONENTS AND CONSUMABLES 110 CHAPTER 14 PRODUCT APPROVAL 114 CHAPTER 15 STORAGE AND DISTRIBUTION 117 CHAPTER 16 INTERNAL AND EXTERNAL AUDIT 122 CONTENTS (PART A Standards )Acknowledgements, news and updates.

5 Available at: 2016 additional supporting resources to aid implementation of the Standards will be developed into a handbook. The handbook will provide part A Standards and part B support resources. Further news and updates on access to part B and its planned launch as part of Quality Assurance Aseptic Preparation Services: Standards Handbook is available at: Assurance OF Aseptic Preparation SERVICES: Standards PART A3 PREFACER eferencesRoyal Pharmaceutical Society (RPS) (2015). Transforming the Pharmacy Workforce in Great Britain: The RPS Vision.

6 London: Royal Pharmaceutical Society. Available at: (accessed 12 February 2016).Royal Pharmaceutical Society (RPS). Quality Assurance of Aseptic Preparation Services (news). Standards for the Quality Assurance of Aseptic Preparation services are a joint initiative between the Royal Pharmaceutical Society and the NHS Pharmaceutical Quality Assurance Committee. We share an aim to develop national Standards that support best practice and the care of patients. Pharmacy Aseptic Preparation services are supporting the care of some of the most critically ill the Standards have been revised and updated for this fifth edition.

7 The Standards are well established and widely used by UK hospital pharmacy departments. Their origin goes back prior to 1993, when the first edition of Quality Assurance of Aseptic Preparation Services was published by the NHS Quality Control relationship between the Royal Pharmaceutical Society and the NHS Pharmaceutical Quality Assurance Committee extends over many years and our publishing division, the Pharmaceutical Press (RPS Publishing), has previously published the third and fourth editions of Quality Assurance of Aseptic Preparation Services.

8 Since 2010 the Royal Pharmaceutical Society has become a body akin to a Royal College. As such, it is appropriate for us to produce and host these Standards as part of our library of professional Standards . The Standards have particular relevance to the RPS leadership roles, including our vision for the pharmacy workforce (RPS 2015).I would like to join the editor, Dr Alison M Beaney, in thanking the contributors. These Standards are a result of the hard work and dedication of many experts from across the UK.

9 In the UK these nationally agreed Quality Standards and an audit programme are in place to assure the Quality of pharmacy Aseptic units (unlicensed) within the NHS. The Standards are primarily intended for use within the NHS but they will also be of use to students, licensed units, individuals and organisations in other countries as well as the Soni OBE FFRPS FRPharmSPresident Royal Pharmaceutical SocietyCHAPTER 1 INTRODUCTIONQUALITY Assurance OF Aseptic Preparation SERVICES: Standards PART A4 Aseptic Preparation of medicines is an important part of the service provision by pharmacy departments to facilitate accurate and timely administration of injectable medicines for patients.

10 It is a complex and demanding activity requiring skilled staff, appropriate facilities and close monitoring and control. Standards to guide and monitor the safe and accurate delivery of these services have evolved gradually, reflecting the changing expectations and needs for maintaining the high Quality of Aseptic products in the context of rising workload pressures, often reduced resources, and the increasing complexity of modern medicines. The Standards contained herein address these issues in a practical way and should assist both those providing these services and those whose role it is to audit Preparation in the UK is only exempt from the licensing requirements of the Medicines Act 1968 and subsequent amendments provided all of the following conditions are met (MCA 1992).