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
 

1. Scope of these guidelines

These guidelines are intended to complement those already available for pharmaceutical products (1,2) as well as those for sterile pharmaceutical products (3).

The regulatory procedures necessary to control radiopharmaceutical products are in large part determined by the sources of these products and the methods of manufacture. Manufacturing procedures within the scope of these guidelines include:

• The preparation of radiopharmaceuticals in hospital radio-pharmacies.

• The preparation of radiopharmaceuticals in centralized radio-pharmacies.

• The production of radiopharmaceuticals in nuclear centres and institutes or by industrial manufacturers.

• The preparation and production of radiopharmaceuticals in positron emission tomography (PET) centres.


Radiopharmaceuticals can be classified into four categories:

1. Ready-for-use radioactive products.

2. Radionuclide generators.

3. Non-radioactive components (“kits”) for the preparation of labelled compounds with a radioactive component (usually the eluate from a radionuclide generator).

4. Precursors used for radiolabelling other substances before administration (e.g. samples from patients).


Radiopharmaceutical products include inorganic compounds, organic compounds, peptides, proteins, monoclonal antibodies and fragments, and oligonucleotides labelled with radionuclides with half-lives from a few seconds to several days.

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