Overview

Full Product Details

Author:   Alison M. Beaney (Regional Quality Assurance Specialist for the North East and North Cumbria, Newcastle upon Tyne Hospitals NHS Foundation Trust)
Publisher:   Pharmaceutical Press
Imprint:   Pharmaceutical Press
Edition:   5th Revised edition
ISBN:  

9780857113078

ISBN 10:   0857113070
Pages:   272
Publication Date:   05 October 2016
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Paperback
Publisher's Status:   Active
Availability:   In Print  
This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us.

Table of Contents

Part A - standards Chapter 1 Introduction Chapter 2 Definitions/Glossary of terms Chapter 3 Minimising risk with injectable medicines Chapter 4 Prescribing, clinical pharmacy and aseptic services verification Chapter 5 Management Chapter 6 Formulation stability and shelf life Chapter 7 Facilities and equipment Chapter 8 Pharmaceutical Quality System Chapter 9 Personnel, training & competency assessment Chapter 10 Aseptic processing Chapter 11 Monitoring Chapter 12 Cleaning, sanitisation and biodecontamination Chapter 13 Starting materials, components and other consumables Chapter 14 Product approval Chapter 15 Storage and distribution Chapter 16 Internal and external audit Part B - support resources 1 Microbiological environmental monitoring techniques for the laboratory 2 Validation of aseptic preparation procedures: 2.1 Microbiological validation of the process 2.2 Microbiological validation of the operator 2.3 Product validation 2.4 Validation of training 2.5 Validation of cleaning processes 2.6 Computerised system validation 3 Technical (quality) agreements 4 Products for short-term use - maximum shelf life 24 hours 5 Capacity planning - technical services 6 Advanced therapy medicinal products (ATMPs)

Reviews

Author Information

Alison Beaney is Regional Quality Assurance Specialist for the North East and North Cumbria, and is based in Newcastle upon Tyne hospitals NHS Foundation Trust. She is currently Chair of the NHS Pharmaceutical Quality Assurance Committee and has also served as Secretary. She edits Quality Assurance of Aseptic Preparation Services on behalf of the Royal Pharmaceutical Society and the Committee. Alison is a Fellow of the Royal Pharmaceutical Society and obtained a professional Doctorate on the topic of the preparation of medicines in 2010 from the University of Sunderland where she is a visiting professor. In addition, Alison is actively involved in the management and teaching of the Pharmaceutical Technology and Quality Assurance (PTQA) postgraduate course in association with the University of Manchester.

Tab Content 6

Author Website:  

Customer Reviews

Recent Reviews

No review item found!

Add your own review!

Countries Available

All regions