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
 

2.13 Confidentiality Undertaking

The evaluators and inspectors will treat all information to which they will gain access during the evaluations and inspections, or otherwise in connection with the discharge of their responsibilities in regard to the above-mentioned project, as confidential and proprietary to WHO or parties collaborating with WHO in accordance with the terms set forth below and those contained in the attached Provisions for evaluators of product dossiers and inspectors (team members participating in site visits) within the scope of the quality assessment procedure of pharmaceutical products.

Evaluators and inspectors will take all reasonable measures to ensure

(a) that confidential information is not used for any other purpose than the evaluation/inspection activities described in this document, and

(b) that it is not disclosed or provided to any person who is not bound by similar obligations of confidentiality and non-use as contained herein.


Evaluators and inspectors will not, however, be bound by any obligations of confidentiality and non-use to the extent they are clearly able to demonstrate that any part of the confidential information:

- was known to them prior to any disclosure by or on behalf of WHO (including by manufacturers); or

- was in the public domain at the time of disclosure by or on behalf of WHO (including by manufacturers); or

- has become part of the public domain through no fault of theirs; or

- has become available to them from a third party not in breach of any legal obligations of confidentiality.

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