Thorough GMP Auditing And Dangerous Active Pharmaceutical Ingredients

Posted by joanne on November 20th, 2009 at 06:33pm

We are affected by medicines because of the Active Pharmaceutical Ingredients or API which is in them. Patents are supposed to uphold the integrity of these APIs however a recent development in the pharmaceutical world means that there are thousands of off-patent drugs used in countries around the world. 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 APUIs could contain toxic chemicals because they have not been through GMP auditing. The length of the supply chain that these falsified APIs travel along makes it difficult to inspect whether they are toxic or not. China and India have become the two biggest countries for APIs to be outsourced to because of cheaper labour costs. auditing every stage of production from these countries to the finished product is difficult with so many countries involved.

The European Fine Chemical group has estimated that 80% of medicines which are used in Britain contain APIs from India and China and the European Directorate for the Quality of Medicines and Healthcare (EDQM) has stated that through the results of its audits, ads much as 20-30% of all off-patent medicines in the EU could contain falsified APIs.

With so many drugs entering the EU market, there are unknown numbers of health problems that could occur. Toxic APIs could end up having deathly consequences in some patients. 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. 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.

Under Health and Fitness