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Quality Assurance of Aseptic Preparation Services: Standards Handbook

Online Shop | Pharmaceutical Press | Practice: Drug Preparation |  Quality Assurance of Aseptic Preparation Services: Standards Handbook

Quality Assurance of Aseptic Preparation Services: Standards Handbook


In Paperback Format
Quality Assurance of Aseptic Preparation Services: Standards Handbook

£43.70
 RRP: £46.00
You save £2.30 (5.0%)
ISBN
9780857113078
Author
Alison M Beaney
Published by
Pharmaceutical Press
Publication Date
October 2016
Edition
Fifth edition
Format
Paperback
Extent
272 pages
Dimensions
148 x 210 mm
Trade Tariff Code
490199

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.  
  1. Introduction
  2. Definitions
  3. Risk Management
  4. Prescribing and prescription verification
  5. Management
  6. Formulation, Stability and Shelf-life
  7. Facilities
  8. Documentation
  9. Personnel, Training and Competency Assessment
  10. Aseptic Processing
  11. Monitoring
  12. Cleaning
  13. Starting Materials, Components and Other Consumables
  14. Product Approval
  15. Storage and Distribution
  16. Internal and External Audits
  1. Laboratory protocols for microbiological environmental monitoring techniques
  2. Validation of aseptic preparation procedures
  3. Model technical agreement for the supply of microbiological services to the pharmacy aseptic unit by the microbiological service
  4. Products for short-term use - maximum shelf life 24 hours
  5. Capacity planning - technical services
  6. Gene therapy


Online Shop | Pharmaceutical Press | Practice: Drug Preparation |  Quality Assurance of Aseptic Preparation Services: Standards Handbook

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