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
Close this folderAnnex 8 Procedure for assessing the acceptability, in principle, of pharmaceutical products for purchase by United Nations agencies
View the document1. Introduction
Close this folder2. Steps of the procedure
View the document2.1 Publication of Invitation for Expression of Interest (EOI)
View the document2.2 Submission of Dossiers
View the document2.3 Screening of dossiers submitted
View the document2.4 Dossier assessment
View the document2.5 Site Inspection
View the document2.6 Report and outcome of evaluation
View the document2.7 Assessment results
View the document2.8 Procurement, sourcing and supply
View the document2.9 Re-evaluation
View the document2.10 Testing of samples
View the document2.11 Monitoring of Complaint(s)
View the document2.12 Cost Recovery
View the document2.13 Confidentiality Undertaking
View the document2.14 Conflict of Interest
View the documentAppendix Provisions for evaluators of product dossiers and for inspectors (team member participating in site visits) within the scope of the quality assessment procedure of pharmaceutical products
View the documentReferences
Open this folder and view contentsAnnex 9 Guide to good storage practices for pharmaceuticals1
View the documentBack cover
 

2.7 Assessment results

Once WHO is satisfied that the quality assessment process is complete for the manufacturer of the relevant product and that the product is acceptable in principle for procurement by UN Agencies (i.e. it has been found to meet the WHO recommended standards), the product, as produced at the specified manufacturing site, will be included in the list.

Manufacturers on the list will be considered to be manufacturing the relevant listed pharmaceutical products, of acceptable quality, and in compliance with WHO recommended GMP guidelines and other recommended standards, such as described in “Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource (Generic) Products. A Manual for a Drug Regulatory Authority. Regulatory Support Series, No.5 (WHO/DMP/RGS/98.5). Geneva, World Health Organization, 1999. The quality assessment is valid only for those product(s) submitted by the manufacturer in the EOI, evaluated by WHO, and appearing on the list.

Each manufacturer receives a letter from WHO informing the manufacturer of the outcome of the quality assessment process in regard of the particular product(s) of that particular manufacturer. A copy of this letter will be sent to the DRA of the country of manufacture.

The list will be compiled in accordance with an SOP established by WHO for final decision making for inclusion in the list and will be subjected to review at least once a year. The list will be published and be included on the WHO web page.

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