Description
Book SynopsisQuality 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.
Table of ContentsPart 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)
