Quality Assurance of Aseptic Preparation ServicesAlison M. Beaney A detailed guide to the operation and quality assurance of UK hospital aseptic preparation services This new edition of Quality Assurance of Aseptic Preparation Services provides information and up to date national guidance on unlicensed aseptic preparation. Although it is primarily intended for the use of non-licensed UK hospital pharmacies, it will also be of use in licensed units and other countries and institutions. Aseptic services include the preparation of parenteral nutrition solutions (PN), cytotoxics, radiopharmaceuticals, additives for parenteral administration and intrathecals Since the publication of the Breckenridge report in 1976, which recommended that drug additions to intravenous (IV) infusions should be made in hospital pharmacy departments and not on wards, there has been a substantial increase in hospital pharmacy departments providing aseptic preparation services |
Contents
Definitions | 3 |
Formulation stability and shelf life | 28 |
Personnel training and competency assessment | 38 |
Aseptic processing | 44 |
Monitoring | 52 |
Product approval | 60 |
Validation of aseptic preparation procedures | 91 |
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Common terms and phrases
agar plates Appendix appropriate areas Aseptic Preparation Services aseptic preparation unit aseptic processing aseptic technique aseptic unit Assurance of Aseptic audit Authorised Pharmacist autoclave bacteria capacity planning chemotherapy clean room clinical trial contact plates Containment Level critical zone cytotoxic Department of Health dextrose disinfection documented doses ensure environment environmental monitoring equipment extent risk assessment facilities gene therapy Genetically Modified Organisms GMOs Gram stain Gram-positive guidance HEPA hospital identified Incubate infection intravenous laboratory laminar flow cabinet London Medicinal Products microbial contamination microbiological microorganisms minimise NHS Pharmaceutical Quality parenteral nutrition patients Pharm products prepared programme propofol Quality Assurance Quality Control radiopharmaceuticals required Not required required Required Required Responsible Pharmacist risk assessment shows Sabouraud dextrose agar safety settle plates shelf slide solution specific stability staff staff grade Standard Operating Procedures sterile storage suitable surface swab transfer tryptone soya agar validation vectors viral workload
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Page 142 - NOTE FOR GUIDANCE ON STABILITY TESTING: STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS (CPMP/ICH/380/95) 7 Wtestferry Circus.
Page 142 - Guidelines for the provision of radiopharmacy support to nuclear medicine. Report of a Joint Working Group of the British Institute of Radiology, the British Nuclear Medicine Society and the UK Radiopharmacy Group, Autumn 2001. Nucl Med Commun 2003; 24: 429^34. 98 UK Registrars' Group, http://www.ukrg.org (accessed 23 June 2005).