Detailed GMP Auditing And Falsified APIs
Sunday, January 31st, 2010We are affected by medicines because of the Active Pharmaceutical Ingredients or API which is in them. The growth of off-patent medicines means that a patent does not always protect the integrity of the API. With all of these drugs on the market many companies find themselves having to lower their prices to remain competitive, and using substandard ingredients is becoming an increasingly popular way to do this.
These falsified APUIs could contain toxic chemicals because they have not been through GMP auditing. One of the main problems with knowing whether the API in a drug is falsified or not is because of the long supply chain that many medicines go through before they reach their final market. Cheaper labour costs have led to many companies outsourcing the API production to India and China. However, this long supply chain makes it incredibly difficult to inspect every aspect of production.
it has been estimated by The European Fine Chemical group that 80% of medicines on the British healthcare system have APIs which were manufactured in India or China, whilst the European Directorate for the Quality of Medicines and Healthcare (EDQM) estimates that 20-30% of off-patent medicines in the EU have falsified APIs in them.
This is a huge number of medicines and the consequences could be fatal. Toxic APIs could end up having deathly consequences in some patients. This could be done through accidental overdose if the API is similar to any other medication that they are taking, or it might also occur in a case where two different APIs react fatally with each other.
Over the past 10 years the results of GMP Auditing has uncovered a rise in the number of substandard APIs coming from Indian and Chinese manufacturers. 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. But it is a moral issue that companies are prepared to release substandard and potentially fatal drugs onto the market all in the name of bigger profit margins.











