WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 908 - Thirty-seventh Report
(2003; 148 pages) View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Open this folder and view contents2. General policy
Open this folder and view contents3. Quality control - specifications and tests
View the document4. Quality control - international reference materials
Open this folder and view contents5. Quality control - national laboratories
Open this folder and view contents6. Quality assurance - good manufacturing practices
Open this folder and view contents7. Quality assurance - inspection
Open this folder and view contents8. Quality assurance - distribution and trade-related
Open this folder and view contents9. Quality assurance - risk analysis
Open this folder and view contents10. Quality assurance - drug supply
Open this folder and view contents11. Quality assurance - storage
View the document12. International Nonproprietary Names (INNs) programme
Open this folder and view contents13. Miscellaneous
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1 Recommendations on risk of transmitting animal spongiform encephalopathy agents via medicinal products
View the documentAnnex 2 The International Pharmacopoeia: revised concepts and future perspectives
Close this folderAnnex 3 Guidelines on Good Manufacturing Practices for radiopharmaceutical products
View the document1. Scope of these guidelines
View the document2. Principles
View the document3. Personnel
View the document4. Premises and equipment
View the document5. Production
View the document6. Labelling
View the document7. Production and distribution records
View the document8. Quality assurance and quality control
View the documentAcknowledgements
View the documentReferences
Open this folder and view contentsAnnex 4 Good Manufacturing Practices for pharmaceutical products: main principles
View the documentAnnex 5 Model certificate of Good Manufacturing Practices
View the documentAnnex 6 Guidance on Good Manufacturing Practices (GMP): inspection report
View the documentAnnex 7 Application of Hazard Analysis and Critical Control Point (HACCP) methodology to pharmaceuticals
Open this folder and view contentsAnnex 8 Procedure for assessing the acceptability, in principle, of pharmaceutical products for purchase by United Nations agencies
Open this folder and view contentsAnnex 9 Guide to good storage practices for pharmaceuticals1
View the documentBack cover

3. Personnel

3.1 The manufacturing establishment, whether a hospital radiopharmacy, centralized radiopharmacy, nuclear centre or institution, industrial manufacturer or PET centre, and its personnel should be under the control of a person who has a proven record of academic achievement together with a demonstrated level of practical expertise and experience in radiopharmacy and radiation hygiene. Supporting academic and technical personnel should have the necessary postgraduate or technical training and experience appropriate to their function.

3.2 Personnel required to work in radioactive, clean and aseptic areas should be selected with care, to ensure that they can be relied on to observe the appropriate codes of practice and are not subject to any disease or condition that could compromise the integrity of the product. Health checks on personnel should be requested before employment and periodically thereafter. Any changes in personal health status (e.g. in haematology) may require the temporary exclusion of the person from further radiation exposure.

3.3 Only the minimum number of personnel required should be present in clean and aseptic areas when work is in progress. Access to these areas should be restricted during the preparation of radiopharmaceuticals, kits or sterile set-ups. Inspection and control procedures should be conducted from outside these areas as far as possible.

3.4 During the working day, personnel may pass between radioactive and non-radioactive areas only if the safety rules of radiation control (health physics control) are respected.

3.5 The release of a batch may be approved only by a pharmacist or a person with academic qualifications officially registered as a suitably qualified person, and with appropriate experience in the manufacture of radiopharmaceuticals.

3.6 To ensure the safe manufacture of radiopharmaceuticals, personnel should be trained in GMP, the safe handling of radioactive materials and radiation safety procedures. They should also be required to take periodic courses and receive training to keep abreast of the latest developments in their fields.

3.7 Training records should be maintained and periodic assessments of the effectiveness of training programmes should be made.

3.8 All personnel engaged in production, maintenance and testing should follow the relevant guidelines for handling radioactive products and be monitored for possible contamination and/or irradiation exposure.

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