Monitoring and Quality Assurance

Manufacturing a pill is technically easy, but manufacturing a medicine that delivers an active compound in a narrowly defined dose range and within a time that ensures clinical efficiency is much more difficult. Inappropriate storage and transport conditions can deteriorate product performance so that there is no more therapeutic activity left.

There are countless reports of sub-standard, ineffective or not reliably effective drugs found in the distribution channels in developing (and sometimes as well in developed) countries. Setting up a regulatory agency that acts as a gatekeeper against substandard drugs is one important step (see previous chapter). However, this does not guarantee that the batches that are actually delivered after approval meet the quality standards set forth in the registration dossier, and that drugs are handled in such a way that their effectiveness is preserved.

Parameters to look at in building up a quality assurance system are

• Functioning approval system (gatekeeper, see previous chapter)
• Simple, efficient logistics systems with a minimal number of hand-overs and good tracking tools
• Schedule for sampling and testing of drugs at various point in the chain, but particularly at the point of delivery, to identify substandard drugs
• Capacity to do simple lab tests in peripheral health centers/pharmacies (e.g. with Minilab from German Pharma Health Fund)
• Sanctions against suppliers who do not meet agreed standards
• Open communication of activities and results to raise awareness and build public confidence in drug quality

For further study:

WHO Project on Counterfeit and Substandard Medicines:
http://www.who.int/medicines/organization/qsm/activities/qualityassurance/cft/counterfeit_info.shtml

German Pharma Health Fund Minilab:
http://www.gphf.org/web_en/projekte/minilab/index.htm