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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
Open this folder and view contentsAnnex 3 Guidelines on Good Manufacturing Practices for radiopharmaceutical products
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
 

Annex 1 Recommendations on risk of transmitting animal spongiform encephalopathy agents via medicinal products

© World Health Organization
WHO Technical Report Series, No. 908, 2003

Products with risk of transmitting agents of animal spongiform en-cephalopathies are those derived from tissues or secretions of animals susceptible to transmissible spongiform encephalopathies other than by experimental challenge. This definition applies to all substances or preparations obtained from such animals and to all substances or preparations where products obtained from such animals are included as active substances or excipients or have been used during production, e.g. as raw or source materials, starting materials or reagents.

Materials of animal origin should be avoided whenever possible. However, if used, manufacturers should be aware of the risk and have a system in place to minimize it, especially since international trading patterns, often include the processing and re-export of products, so that their origin may not be traceable.

In order to minimize the risk of transmitting animal spongiform ecephalopathy agents via medicinal products, manufacturers should follow the recommendations of the Joint Technical Consultation on Bovine Spongiform Encephalopathy, public health, animal health and trade, convened by the WHO, the Food and Agriculture Organization of the United Nations and the Office International des Epizooties 11 - 14 June 2001 in Paris.1

1Proceedings - Joint WHO/FAO/OIE Technical Consultation on BSE: public health, animal health and trade. Paris: Office International des Epizooties, World Health Organization, Food and Agriculture Organization, World Organisation for Animal Health; 2002.

 

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