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

2.14 Conflict of Interest

Before undertaking the work, each evaluator and inspector will also (in addition to the above mentioned confidentiality undertaking) be required to sign a Declaration of Interest. If based on this Declaration of Interest, it is felt that there is no risk of a real or perceived conflict of interest and it is thus deemed appropriate for the evaluator or inspector in question to undertake this work, he/she will discharge his/her functions exclusively as adviser to WHO. In this connection, each evaluator and inspector is required to confirm that the information disclosed by him/her in the Declaration of Interest is correct and that no situation of real, potential or apparent conflict of interest is known to him/her, including that he/she has no financial or other interest in, and/or relationship with a party, which:

(a) may have vested commercial interest in obtaining access to any Confidential Information disclosed to him/her in the course of the evaluation/inspection activities described in this document; and/or

(b) may have a vested interest in the outcome of the evaluation activities/inspection including, but not limited to, parties such as the manufacturers whose products are subject to evaluation or manufacturers of competing products.

Each evaluator and inspector will undertake to promptly advise WHO of any change in the above circumstances, including if an issue arises during the course of his/her work for WHO.

All inspectors furthermore agree, that at the manufacturer’s request, WHO will advise the manufacturer in advance of the identity of each inspector and composition of the team performing the site inspection, and provide curricula vitae of the inspectors. The manufacturer then has the opportunity to express possible concerns regarding any of the inspectors to WHO prior to the visit. If such concerns cannot be resolved in consultation with WHO, the manufacturer may object to a team member’s participation in the site visit. Such an objection must be made known to WHO by the manufacturer within ten days of receipt of the proposed team composition. In the event of such an objection, WHO reserves the right to cancel its agreement with the inspector, and the activities to be undertaken by that inspector, in whole or in part.

to previous section
to next section
The WHO Essential Medicines and Health Products Information Portal was designed and is maintained by Human Info NGO. Last updated: December 6, 2017