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[e-drug] Traceability in Bidding Documents (2)

E-DRUG: Traceability in Bidding Documents (2)

Dear Colleague,

I assume (1), that your inquiry relates to tender documentation
specifically for procurement of medicines and (2), that "traceablity"
refers to bidders' commitment to a Quality Management System being in
place, for the identification of causes of non-conformance to specification
during/after execution of a contract. If this is an accurate understanding,
then I suggest that for medicines, it should be sufficient to have bidders
commit to their products being manufactured in conformity with c-GMP
Guidelines according to WHO. The guidelines embody all critical medicine
quality issues, including traceability.If you however wish to really
emphasise "traceability" as such, then it might be useful to refer to the
relevant WHO Technical Report Series on this subject(e.g. TRS 863, readily
and freely accessible at their website, from where you can couch an
appropriate wording to suit your local focus and purpose.

I hope this helps in some way, and good luck in your work.

Murtada M Sesay
UNICEF Supply Division
Copenhagen, Denmark

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