Detailed GMP Auditing And Harmful Active Pharmaceutical Ingredients

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Detailed GMP Auditing And Harmful Active Pharmaceutical Ingredients

Saturday, February 6th, 2010 Subscribe To Our Feed

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. Some companies have turned to using falsifies substandard APIs in their drugs they manufacture so that they can lower production costs and maintain profits.

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. 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. With so many factors to the production of the drugs, it is hard to audit every step of the process.

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.

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. 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. And the EDQM predicts that these figures will continue to grow over the next decade.

GMP auditing is the only way to catch the producers of falsified APIs and it is one of the most important aspects of the pharmaceutical industry. However one thing is for sure, it is morally abhorrent to release deadly APIs onto the market all in the name of bigger profits.

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