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Sleep News Blog

Prescription Sleep Medicine

FDA Consulting and the Global Production Chain

Posted by sleepyguy in Prescription Sleep Medicine on January 16th, 2011

There is significant evidence that the US Food and Drug Administration (FDA) is continuing to focus on its domestic drug production rather than the global supply chain that has spread over recent years. Many believed that 2008-2009 would see a shift in the FDA’s focus from the finished product to the global production line including the API or active ingredient. This is following the 2008 heparin Affair in which contaminated doses of the blood thinner Heparin killed hundreds of people in the US and UK.

The API in the contaminated Heparin had entered the US from China and a severe backlash from congress denouncing the effectiveness of the FDA was predicted to influence a new approach to FDA consulting and regulations. The pharmaceutical industry expected the FDA to shift its focus away from the domestic finished product manufacturers and on to China and other prominent suppliers of APIs.

This argument follows a recent examination of FDA warning letters issued between 2008 and 2009.Over 80% of them were issued to domestic pharmacy companies supporting the fact that the FDA still has a narrow scope of action. A similar percentage focused on finished products rather than APIs. Again this supports the argument that the FDA would rather target domestic companies rather than foreign producers.

The letters raise concerns over the actions of pharmaceutical companies around the world, as the majority of them address the company’s lack of action after a critical inspection. This only highlights the importance of FDA consulting by every business in the sector so that they can comply with the current Good Manufacturing Practices and make sure that their audits produce acceptable results.

There are several things you can do to get up to date with FDA regulations if you are in the pharmaceutical industry;

- Training: GMP training and pharmaceutical training should be undertaken by every employee in the sector to make sure that they understand the consequences of their individual and collective actions.

- GMP Auditing can be carried out by specialist GMP consultants prior to any official FDA inspections giving you time to learn your weaknesses and fix them.

- FDA consulting and paying for pharmaceutical consultants to help your business when implementing new manufacturing practices will ensure that none of your actions put the safety or quality of the products you make at risk.

When pharmaceutical companies manufacturing APIs and finished products do not follow the regulations and laws governing their work, the health of millions of people around the world is put at risk. The result of the examination onto the FDA’s warning letters shows that they still need to spread their investigations over the global supply chain instead of narrowly focusing on their domestic companies.