Simplification of the supply chain will be key to ensuring future compliance and quality

Imagine that it is your job to sign the form that releases the product to market.  You've checked that everything is in place - the batch records, the signatures, the test results - so there's no reason why you cannot sign.  The sales people need the revenue, the pharmacists need the inventory, and the patients need the drugs.  The supply chain is secure, compliant, and safe.  So sign.  Are you sure?

Do you really have sufficient confidence in the quality of production throughout the whole supply chain that you can put your signature on the release form?  Since globalisation has become a feature of the industry, maintaining that oversight has become increasingly challenging.  Between 2001 and 2007 the number of manufacturers in India increased by a factor of twenty five, and in China by a factor of seven.  It will almost certainly be true that some of the supply chain will exist in some countries with less well developed regulatory systems than, say, Europe or the US.  How do you know what's really going on in your suppliers, or their suppliers, or theirs.  Your company probably won't have audited them all - you won't have enough auditors in-house, and renting that kind of capability is expensive.  Of course you'll have Quality Assurance Agreements (QAAs) in place for your third party contractors, and those that you have negotiated recently will be good.  But, what of the older ones?  Do they ensure total transparency?  What about your raw material supplier network?  Do your suppliers (and theirs, and theirs etc) fully disclose every Out of Specification (OOS) measurement, every deviation, every change?  How do you know?  Are you still going to sign? 

If you would like to read the article in full, please click the pdf link below:

Quality Management Let's make it simpler not even more complicated.pdf​

or to view the magazine, follow the link below, the article can be found on page 58

http://viewer.zmags.com/publication/00b229e7#/00b229e7/58

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