GMP Auditing And Off-Patent Active Pharmaceutical Ingredients
The part of a drug that makes us better is the Active Pharmaceutical Ingredients or API. Some companies have a patent which means the quality of the API is maintained however off-patent drugs means that this is not always the case. The thousands of drugs which are off-patent means that drug manufacturers have to find ways to lower their costs in order to stay profitable, and using falsified APIs is one way that companies are doing this.
These falsified APIs come from a non-listed source and as such, they have not been through GMP auditing and could actually be toxic to humans. The supply chain which brings APIs into the EU is so long that it is hard to inspect whether the API is falsified or not. China and India have become the two biggest countries for APIs to be outsourced to because of cheaper labour costs. However, this long supply chain makes it incredibly difficult to inspect every aspect of production.
It has been estimated that 20-30% of all off-patent drugs in Europe contain falsified APIs and in Britain, 80% of our medicines contain APIs which were produced in India or China.
These percentages add up to a huge number of drugs entering the EU market and the results could be hundreds or thousands of health issues. Patients could end up dead if they are given drugs containing toxic APIs. Reactions with other medication or accidental overdose are just two of the scenarios that might occur.
GMP Auditing over the past 10 years has seen rising numbers of substandard Active Pharmaceutical Ingredients discovered in Indian and Chinese manufacture bases. Whilst inspecting 160 manufacturers in these two countries the European Directorate for the Quality of Medicines and healthcare suspended or withdrew 50 GMP certificates. These figures have been estimated to grow even further over the next few years.
GMP Auditing is one of the most important features in the pharmaceutical industry due to its inspection and findings of falsified APIs. One thing is for sure though; no company should release potentially toxic medicines onto the general public just in the search to cut costs and make bigger profits.
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