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
Close this folder13. Miscellaneous
View the document13.1 Proposal to the WHO Expert Committee by the Scientific Working Group on Bioequivalence of the International Pharmaceutical Federation (FIP)
View the document13.2 Dissolution tests for quality control
View the document13.3 Electronic version of publications
View the document13.4 Standardized reporting sheet
View the document13.5 Distribution of documents for procedural consultation process
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

13.4 Standardized reporting sheet

The reporting of experimental results on the verification and validation of analytical methods and requirements, e.g. basic tests and specifications for pharmacopoeial monographs, has not yet been standardized. As a result, reports received from collaborating centres or experts vary widely.

The Committee recommended that a standardized reporting sheet should be used by collaborating centres and experts for reporting experimental results and data. This would lead to better traceability regarding the development and validation of quality specifications.

The Secretariat was asked to draft a standard report sheet which will be circulated for comments before it is introduced.

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