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
Close this folder9. Quality assurance - risk analysis
View the document9.1 Risk analysis in quality control and impurities
View the document9.2 Application of hazard analysis and critical control point methodology for pharmaceuticals
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
 

9.1 Risk analysis in quality control and impurities

The Committee noted that, even though there was an increasing shift to more sophisticated methods and more stringent test limits internationally, no scientific data were available that demonstrated that the safety of patients was thereby increased. It was therefore recommended that specifications published to date in The International Pharmacopoeia should be maintained and the currently used approach retained. The monographs published in The International Pharmacopoeia can thus be retained - subject to the normal revision process - especially as the majority of monographs concern well known essential drugs proved to be safe over a long period of time.

For new monographs, it was important to define a level of impurities consistent with those in other official standards or pharmacopoeias. The fact that different pharmacopoeias may provide different specifications for varying impurities profiles for the same product must also be considered. If available, harmonized monographs should be preferred.

The recently adopted approach to include - in newly developed monographs - alternative test specifications should also be maintained. The policy is to introduce less technically demanding analytical procedures as alternatives when more sophisticated methods are described in the monograph (Annex 2).

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