Quality Assurance of Aseptic Preparation Services: Standards Handbook

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.

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)

From the reviews of the previous editions

"...a well written and extensively referenced book...an invaluable resource for those working in those hospital pharmacy departments which provide aseptic preparation services...

...very useful for those responsible for the teaching of aseptic preparation to pharmacy students...contains a wealth of pertinent information, clearly and concisely presented"

1 Mar 2002, Pharmacy Education