Quality assurance of aseptic preparation services : standards handbook : parts A and B

Yellow guide

Text includes: 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 and competency assessment; Aseptic processing; Monitoring; Cleaning, sanitisation and biodecontamination; Product approval; Storage and distribution; Internal and external audit; Microbiological validation of the process; Validation of training; Computerised system validation; Capacity planning - technical services; Advanced Therapy Medicinal Products (ATMPs).

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 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.