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Quality Assurance of Aseptic Preparation Services: Standards Handbook
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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.
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.
Data sheet
- Publication date
- 2016
- Issue number
- 5
- Cover
- paperback
- Pages count
- 272
- Dimensions (mm)
- 1480.00 x 2100.00
- 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)
Reference: 93363
The Doctor and the Algorithm
Author: S. Scott Graham
Promise, Peril, and the Future of Health AI
Reference: 31668
Coronary Artery Disease
Author: Ole Faergeman
Genes, Drugs and the Agricultural Connection
Reference: 32915
Handbook of Neuropsychology, 2nd Edition
Author: S. J. Segalowitz
Child Neuropsychology, Part 1
Reference: 75187
Beautiful Skin: A Dermatologists Guide to a Younger Looking You
Author: Keyvan Nouri
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