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
Close this folder5. Quality control - national laboratories
View the document5.1 External quality assessment scheme
View the document5.2 Cost estimate of equipment for model quality control 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

5.1 External quality assessment scheme

The Committee noted that 12 national quality control laboratories had been involved in a external quality assessment scheme, with feedback being obtained from most of these laboratories. It also noted that a second phase involving 36 laboratories would soon commence.

This scheme contributes to the establishment of mutual confidence between users and laboratories, and is a very useful tool for assessing the analytical skills of participating laboratories.

The Committee adopted the following recommendations on the External Laboratory Assessment Scheme made during a consultation held in Geneva in September 2001:

• The same methodology (pharmacopoeia methods) should be used by all laboratories in the statistical evaluation of results.

• This initiative should be pursued provided that funds are available. In experimental studies, the methods given in The International Pharmacopoeia should continue to be used.

• If funds are not available, WHO should inform the laboratories about other existing schemes. In this context, WHO should ask for more information from other sources about existing schemes.


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