Description
Quality Assurance of Aseptic Preparation Services Standards Handbook provides standards for unlicensed aseptic preparation in the UK.
The handbook (also known as the Yellow Guide) delivers essential standards in a practical way. 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. The book is produced on behalf of the Royal Pharmaceutical Society (RPS) and the NHS Pharmaceutical Quality Assurance Committee.
Part A - standards
• Introduction
• Definitions/Glossary of terms
• Minimising risk with injectable medicines
• Prescribing, clinical pharmacy and aseptic services verification
• Management
• Formulation stability and shelf life
• Facilities and equipment
• Pharmaceutical Quality System
• Personnel, training & competency assessment
• Aseptic processing
• Monitoring
• Cleaning, sanitisation and biodecontamination
• Starting materials, components and other consumables
• Product approval
• Storage and distribution
• Internal and external audit
Part B – support resources
• Microbiological environmental monitoring techniques for the laboratory
• Validation of aseptic preparation procedures:
• Microbiological validation of the process
• Microbiological validation of the operator
• Product validation
• Validation of training
• Validation of cleaning processes
• Computerised system validation
• Technical (quality) agreements
• Products for short-term use – maximum shelf life 24 hours
• Capacity planning – technical services
• Advanced therapy medicinal products (ATMPs)
