| There is significant evidence that the US Food and | | | | majority of them address the company's lack of |
| Drug Administration (FDA) is continuing to focus on | | | | action after a critical inspection. This only highlights |
| its domestic drug production rather than the global | | | | the importance of FDA consulting by every business |
| supply chain that has spread over recent years. Many | | | | in the sector so that they can comply with the |
| believed that 2008-2009 would see a shift in the | | | | current Good Manufacturing Practices and make sure |
| FDA's focus from the finished product to the global | | | | that their audits produce acceptable results. |
| production line including the API or active ingredient. | | | | There are several things you can do to get up to |
| This is following the 2008 heparin Affair in which | | | | date with FDA regulations if you are in the |
| contaminated doses of the blood thinner Heparin killed | | | | pharmaceutical industry; |
| hundreds of people in the US and UK. | | | | - Training: GMP training and pharmaceutical training |
| The API in the contaminated Heparin had entered the | | | | should be undertaken by every employee in the |
| US from China and a severe backlash from congress | | | | sector to make sure that they understand the |
| denouncing the effectiveness of the FDA was | | | | consequences of their individual and collective actions. |
| predicted to influence a new approach to FDA | | | | - GMP Auditing can be carried out by specialist GMP |
| consulting and regulations. The pharmaceutical industry | | | | consultants prior to any official FDA inspections giving |
| expected the FDA to shift its focus away from the | | | | you time to learn your weaknesses and fix them. |
| domestic finished product manufacturers and on to | | | | - FDA consulting and paying for pharmaceutical |
| China and other prominent suppliers of APIs. | | | | consultants to help your business when implementing |
| This argument follows a recent examination of FDA | | | | new manufacturing practices will ensure that none of |
| warning letters issued between 2008 and 2009.Over | | | | your actions put the safety or quality of the |
| 80% of them were issued to domestic pharmacy | | | | products you make at risk. |
| companies supporting the fact that the FDA still has | | | | When pharmaceutical companies manufacturing APIs |
| a narrow scope of action. A similar percentage | | | | and finished products do not follow the regulations |
| focused on finished products rather than APIs. Again | | | | and laws governing their work, the health of millions |
| this supports the argument that the FDA would | | | | of people around the world is put at risk. The result |
| rather target domestic companies rather than foreign | | | | of the examination onto the FDA's warning letters |
| producers. | | | | shows that they still need to spread their |
| The letters raise concerns over the actions of | | | | investigations over the global supply chain instead of |
| pharmaceutical companies around the world, as the | | | | narrowly focusing on their domestic companies. |