| Proper and unbiased testing is an integral part of any | | | | there are huge variations in terms of time and |
| manufacturing process. And this is especially vital in | | | | money required for FDA approval. Because of this, a |
| the pharmaceutical industry. Because of the | | | | combination product's designation to a particular |
| pharmaceutical industry's inherent need for quality | | | | department could have a major impact on the |
| control, at the highest levels, a new form of testing | | | | company's ability to finance the product. Because of |
| was required to ensure the highest quality products | | | | this large variation, it has become a tremendous |
| available. This form of testing is known as third party | | | | financial burden to some drug manufacturers, and |
| testing, where an independent third party testing | | | | they want a change. And the change they want is |
| operation, test the quality of the product in question, | | | | third party testing. |
| off site at one of their testing plants. This ensures | | | | Although the FDA's feelings about this are mixed, |
| that both the government and the company itself | | | | they are not altogether opposed to looking into the |
| cannot affect the testing, neither positively nor | | | | idea. But, to even be able to test combination |
| negatively, in any way. This ensures a true unbiased | | | | products at third party testing sites, each product |
| assessment on the quality of the product. | | | | needs to have this same criteria. In order to perform |
| Sounds pretty simple, right? Well, yes it does, in | | | | product testing on combination products certain |
| theory, but when it comes to testing combination | | | | standards are needed to establish what ingredients, |
| products, things get a bit more complicated. Let's | | | | or specific compounds, they are going to test. If |
| clarify this. Before the FDA tests a product, or takes | | | | they are not specific in explaining what they need |
| the product to a third party testing operation, each | | | | tested, then reliable testing can only be successful in |
| FDA product is first assigned to a particular center | | | | testing single name brands. Not only this, but many |
| within the FDA that will have primary jurisdiction over | | | | testing standards are different at different third |
| the product. Combination products, on the other hand | | | | party testing sites, which can complicate matters |
| are assigned to different centers, based on their | | | | even more. |
| "Primary mode of action", which means their primary | | | | As the FDA and the pharmaceutical companies try to |
| purpose. However, making this determination can | | | | reach an agreement on this matter, much more |
| sometimes be difficult and confusing. | | | | standardized testing methods need to be instituted, |
| Before these products can be tested either by the | | | | before any real progress is made. If your company |
| government, or a third party testing group, it has to | | | | would like to know more about third party testing |
| be decided under what jurisdiction it will fall under. | | | | methods of combination products, then contact your |
| Due to the large variations between the different | | | | local pharmaceutical consulting firm for more |
| levels of FDA research and testing departments, | | | | information. |