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Preparation and control of radiopharmaceuticals in hospitals
BOOK
REVIEW
Preparation and Control of Radiopharmaceuticals in Hospitals by KNUD CHRISTENSEN. Technical Published by the International Atomic Energy Agency, Vienna (1979). 120 pp.
Reports
Series, No. 194,
organization of trained and qualified personnel, the design of premises, the type of equipment, the importance of documentation as well as manufacture and radiation safety. Photographs illustrate the text where appropriate. In Chapter 4 the book offers recommendations for good radiopharmacy practice and specific guidelines for a number of simple procedures, such as the preparation of radiopharmaceuticals from generators and kits. In this chapter the various steps involved in the preparation of a radiopharmaceutical with 99mTc-pertechnetate or “-‘“Inindium chloride are described and aspects of quality control, specific installations, record keeping, storage and waste disposal are discussed. Chapter 5 is reserved for the distribution of radiopharmaceuticals. Several useful and practical appendices, a rich glossary and a well-selected list of references complement this book. The author is Mr Knud Christensen, Director of the Isotope Pharmacy of the National Health Service of Denmark. He is a well-known radiopharmacist with special experience in the organization of radiopharmaceutical units in charge of preparation, quality control and distribution of radiopharmaceuticals. We should be grateful to the 1AEA and in particular to Dr J. L. Servian, Project Director, for providing technical, organizational and radiological information for work with radiopharmaceuticals in this well-edited guidebook. It will be beneficial to all working in the field.
The IAEA has published a guidebook to advise people dealing with the preparation, quality control and dispensing of radiopharmaceuticals in hospital centres and small radiopharmacy units. The book lists the special properties of radiopharmaceuticals and general aspects of good radiopharmacy practice as well as safety requirements. It does not cover procedures for the preparation or control of particular radiopharmaceuticals. The importance of high quality of radiopharmaceuticals and the need for specifications for the various chemical compounds and biological samples used in nuclear medicine is emphasized. Attention is drawn to the fact that quality control is only one element to ensure the quality of a product and that quality assurance depends on all elements in a production system. The content is presented in five chapters, In the first chapter the reader is introduced to the scope of the subject and to problems related to the preparation of radiopharmaceuticals with short-lived radionuclides. Since the conditions for preparation and manufacture of radiopharmaceuticals differ widely according to the industrial structure and the nature of the health system in a country, quality is no absolute term and a compremise between risks and benefits must be expected. Chapter 2 contains general aspects of preparation, control and handling of radiopharmaceuticals, with a definition of quality and activity levels and a discussion on specifications for radiopharmaceuticals. Chapter 3 has the general title: “Good Radiopharmacy Practice”, which can be defined as safe and efficacious preparation and handling of radiopharmaceuticals. Since quality must be built into the product during the whole manufacturing process this chapter is devoted to the
ILSE ZOLLE
University
63
of Viennu Austriu
REVIEW
Preparation and Control of Radiopharmaceuticals in Hospitals by KNUD CHRISTENSEN. Technical Published by the International Atomic Energy Agency, Vienna (1979). 120 pp.
Reports
Series, No. 194,
organization of trained and qualified personnel, the design of premises, the type of equipment, the importance of documentation as well as manufacture and radiation safety. Photographs illustrate the text where appropriate. In Chapter 4 the book offers recommendations for good radiopharmacy practice and specific guidelines for a number of simple procedures, such as the preparation of radiopharmaceuticals from generators and kits. In this chapter the various steps involved in the preparation of a radiopharmaceutical with 99mTc-pertechnetate or “-‘“Inindium chloride are described and aspects of quality control, specific installations, record keeping, storage and waste disposal are discussed. Chapter 5 is reserved for the distribution of radiopharmaceuticals. Several useful and practical appendices, a rich glossary and a well-selected list of references complement this book. The author is Mr Knud Christensen, Director of the Isotope Pharmacy of the National Health Service of Denmark. He is a well-known radiopharmacist with special experience in the organization of radiopharmaceutical units in charge of preparation, quality control and distribution of radiopharmaceuticals. We should be grateful to the 1AEA and in particular to Dr J. L. Servian, Project Director, for providing technical, organizational and radiological information for work with radiopharmaceuticals in this well-edited guidebook. It will be beneficial to all working in the field.
The IAEA has published a guidebook to advise people dealing with the preparation, quality control and dispensing of radiopharmaceuticals in hospital centres and small radiopharmacy units. The book lists the special properties of radiopharmaceuticals and general aspects of good radiopharmacy practice as well as safety requirements. It does not cover procedures for the preparation or control of particular radiopharmaceuticals. The importance of high quality of radiopharmaceuticals and the need for specifications for the various chemical compounds and biological samples used in nuclear medicine is emphasized. Attention is drawn to the fact that quality control is only one element to ensure the quality of a product and that quality assurance depends on all elements in a production system. The content is presented in five chapters, In the first chapter the reader is introduced to the scope of the subject and to problems related to the preparation of radiopharmaceuticals with short-lived radionuclides. Since the conditions for preparation and manufacture of radiopharmaceuticals differ widely according to the industrial structure and the nature of the health system in a country, quality is no absolute term and a compremise between risks and benefits must be expected. Chapter 2 contains general aspects of preparation, control and handling of radiopharmaceuticals, with a definition of quality and activity levels and a discussion on specifications for radiopharmaceuticals. Chapter 3 has the general title: “Good Radiopharmacy Practice”, which can be defined as safe and efficacious preparation and handling of radiopharmaceuticals. Since quality must be built into the product during the whole manufacturing process this chapter is devoted to the
ILSE ZOLLE
University
63
of Viennu Austriu