E-DRUG: New QA and procurement guide available
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Dear E-druggers
A new useful publication is now available
Interagency Guidelines: A model quality assurance system for procurement
agencies.
WHO/PSM/PAR/2007.3
Total 136 pages
This is a very comprehensive and detailed guide. The contents pages
indicate the depth of material included. The main headings from the
modules follow -- inclusion of subheadings would make the message too long.
The whole document can be downloaded from:
www.who.int/medicines/publications/ModelQualityAssurance.pdf
Do have a look at it.
Module I. General requirements for procurement agencies
I.1 Physical resources
I.2 Documentation of policies and standards.
Module II. Prequalification
II.1 Principles for prequalification
II.2 Standards for prequalification
II.3 Key persons and responsibilities
II.4 Key steps in prequalification
II.5 Requalification and monitoring
II.6 Monitoring of complaints
II.7 Cost recovery
Module III. Purchasing
III.1 Strategies for health systems
III.2 Procurement methods
III.3 Quality assurance in purchasing
III.4 Key activities in purchasing
III.5 Organization and responsibilities
III.6 Monitoring of performance of prequalified manufacturers
III.7 Patents
III.8 Donations
Module IV. Receipt and storage of purchased products
IV.1 Pre-shipment quality control
IV.2 Receipt of stock
IV.3 Post-procurement quality control
IV.4 Storage of materials and products
Module V. Distribution
V.1 Transport conditions
V.2 Cold chain
V.3 Temperature monitoring and records.
V.4 Delivery order
V.5 Dispatch procedures and policies
V.6 Dispatch containers
V.7 Dispatch records
V.8 Traceability
V.9 Port of entry
V.10 Packaging of products and materials
Module VI. Reassessment
VI.1 Re-evaluation of manufacturers
VI.2 Re-evaluation of products
VI.3 Monitoring of contracted-out services
Appendix 1 -- Example of a code of conduct.
Appendix 2 -- Example of a guideline on confidentiality
Appendix 3 -- Example of a guideline on conflict of interest.
Appendix 4 -- Example of a standard operating procedure (SOP) for
writing an SOP
Appendix 5 -- Example of an invitation for expression of interest
Appendix 6 -- Pharmaceutical product questionnaire
Appendix 7 -- Example of a standard operating procedure for screening
and assessing product information
Appendix 8 -- Technical questionnaire for pharmaceutical manufacturers
Appendix 9 -- Example of a standard operating procedure for planning of
inspections
Appendix 10 -- Example of a standard operating procedure for preparing
for an inspection
Appendix 11 -- Example of a standard operating procedure for performing
an inspection
Appendix 12 -- Example of a checklist for good manufacturing practices
Appendix 13 -- Guidance on good manufacturing practices: inspection report
Appendix 14 -- Good storage practice
Appendix 15 -- Good trade and distribution practices
Appendix 16 -- Quality system recommendations for pharmaceutical
inspectorates
--
*Beverley Snell*
*Senior Fellow*
*Centre for International Health*
*Macfarlane Burnet Institute for Medical Research & Public Health *
*GPO Box 2284, Melbourne 3001 Australia*
*http://www.burnet.internationalhealth.edu.au***
*Telephone 613 9282 2115 / 9282 2275*
*Fax 61 3 9282 2144 or 9282 2100*
*Time zone: 10 hours ahead of GMT.*
*email <bev@burnet.edu.au>*
*Site: Alfred Medical Research & Education Precinct (AMREP),*
*85 Commercial Road, Prahran 3004*