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Re: E-DRUG: Amateur assessment of GMP (message From Tim Dodd, dd.

end of April)
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E-DRUG: Amateur assessment of GMP

This problem occurs in all developing countries, even at high level, for
instance at the level of all central drug agencies in African countries,
where there is no or very few possibility to audit the drug suppliers.

End of March occured at Libreville, Gabon, the 3rd Conference of the
Ministries of Health of the CFA area and associated countries : there
was ± 15 French African countries and a few associated English African
countries represented.
The previous Conference (Brussels, April 1995) recommended to create 6
workgroups on different pharmaceutical policies matters, one of these
was in charge of the quality  assurance in the purchase procedures, in
particular in the tendering procedures.

I worked supporting this workgroup, which developed three complete
tendering dossiers ((i) prequalification of the drug suppliers, (ii)
restricted call for tenders, and (iii) international open call for
tenders), all including a strong technical dossier, and finally made
major recommendations, to the governments of there respective countries,
to the funders present in the field of Africa and also to the central
drug purchase agencies.  All this was agreed during the Conference by
the Mnistries, with engagement to implement it in their respective
countries.

The technical dossier include (i) the technical specifications, (ii) a
detailed technical description of ± 265 items (drugs and medical
supplies), (iii) a very complete questionnaire to the suppliers, and
(iv) a very complete technical product information card.

The "supplier questionnaire" includes 4 parts : (i) general information
(administrative and commercial), (ii) pharmaceutical information,
specific for the wholesalers, (iii) pharmaceutical information, specific
for the drug producers, and (iv)  pharmaceutical information, specific
for the medical supplies producers.  It has to be filled in completely
by each supplier, the wholesalers are asked to fill in their own part of
the questionnaire and to ask the producers they are representing to fill in
a specific questionnaire also.  So it is possible to have complete
information on
the service and on the supply-chain.  This must be completed by the
obligation, for all the suppliers, to clearly identify the origin of the
drugs, starting the offers.  A wholesaler is accepted only when clearly
identified by a producer for authorised representation.

Two "product information cards" were specifically designed, one for the
drugs and the second for the medical supplies (and all other
pharmaceutical products).  The product information must be detailed for
each item a supplier is proposing, in addition to its questionnaire.
The cards are very complete, including information on the product
design, technical references, origin, packaging, labelling, origin and
quality of the raw materials, stability and expiry, storage conditions,
bio-disponibility or bio-equivalence, samples and product documents
(such as WHO Certification documents, Free Sale Certificates, GMP, and
CE or ISO 9002 Certification).  These documents have to be accompanied
by official certifications, such as Pharmaceutical Practice
Authorisation, GMP, WHO Product Certificates (for each drug), Free Sale
Certficates, etc.

Using these complete documents gives you the ability to build your
purchasing system on a "Document Quality Assurance", providing a good
image of the quality and liability of the suppier service and products,
beeing enhanced by recording the history of the relationship with your
suppliers and trying to build a network with other purchasers around you
(other hospitals of the country, etc.

The documents ("Supplier Questionnaire" and "Product Information Card")
are available on request (contact me at my e-mail address).  These
documents are unfortunately in a French version, the English one is not
yet done.  We are interested with capacities and willingness of
E-Druggers for translation of it.  The complete documents still are to
be translated...

The complete prequalification and call for tenders (restricted and open)
also are available on request. Same remark : in their French version
only, as they also still are to be translated.



Daniel Vandenbergh,
pharmacist

c/o AEDES
34 rue Joseph II
B-1000  Brussels
Belgium
Tel +32.2.209.10.20
Fax +32.2.219.09.38
e-mail dvandenbergh@aedes.be



Tim Dodd a écrit:

> E-drug: Amateur assessment of GMP
> ---------------------------------------------
>
> I'm sure we all share a similar problem of how to assure the
> quality of the drugs we are purchasing, dispensing, and
> administering to patients. The processes that are under our
> direct control are relatively easy to manage through SOP's etc,
> but those that happen before the product reaches us are a
> concern.
>
> Clearly things like GMP are indicators of good practice on the
> part of the manufacturers and in some case it is possible to visit
> and examine the premises of the manufacturer or supplier (agent
> or wholesaler). This is probably more feasible for larger scale
> purchase by Govt departments, charities, NG's etc, where a lot
> of the purchase is carried out through a tendering process and
> lots of additional information can form the requirement of the
> tender. However, there are some much smaller establishments,
> such as my own hospital, where the purchasing is not a one-off,
> annual event, but is a daily, continual occurrence. We need to
> investigate manufacturing quality to just the same extent, but
> often have less resources to do this with. Has anyone developed
> a tool (questionnaire, or similar) to provide for such a situation?
> Do you think on a pragmatic basis, this is a sensible way
> forward? How do others in a situation similar to mine cope with
> this problem?
>
> Tim Dodd
> Director of Pharmacy
> Shaukat Khanum Memorial Cancer Hospital, Lahore, Pakistan
> e-mail: timdodd@brain.net.pk
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