Who Standardizes Testing for the Pharmaceutical Industry?

Testing for the Pharmaceutical Industry

When taking generic medicine, one has to wonder how generic companies know what to test for when making prescription drugs. The pharmaceutical industry has a testing standardization organization known as the United States Pharmacopeia (USP). It is not a government agency but it is recognized by the FDA and the US government as the bible so to speak of pharmaceutical drug testing. The USP is a non-profit scientific organization that standardizes the pharmaceutical, nutritional supplement and food testing fields. On their site (www.usp.org) their mission is to promote public health to ensure the quality, safety and benefits of foods. The US is not the only country to have an organization like this. The European Union (EP) has one as well as Japan (JP).

The USP

I work for a contract pharmaceutical laboratory and any testing that we do for pharmaceutical drugs; the USP has a method for testing and acceptance criteria for approving drugs for consumption. Here is how it works. A lab receives a sample amount of tablets from a generic manufacturer inIndia(happens a lot) for say Atorvastatin (Lipitor). They ask to test it, but they don’t have an in house method since it’s expensive to develop one. So they go to the USP, get their method for free to perform testing, and perform what is required for approval.

The USP provides the method for pharmaceutical testing with the help of industry. They provide a general guide which was developed by the original drug manufacturers for testing the active ingredient. Most of the time it is not the original test method performed when the drug was developed. It is more of a watered down version with the necessary key information. The USP tells you what equipment to use, which chemicals, how to use it and for how long. They do not provide you with the formulation of how to make drugs. Think of them as a cookbook that tells you your cooking times, what ingredients you need, in what order they go in and what utensils or pots to use. They don’t tell you how to exactly prepare the ingredients or if to stir, etc.

Conflict of Interest

I know, I know. If the methods are downloaded free out of their database, where do they get funding?  The government doesn’t give them any money that I know of. They don’t report their earnings since they are a non-profit. They make their income when they sell the standards the industry uses for drug testing. The USP is the only source in the US to go to for purchasing standards. If drug testing is performed on components from Japan, then you go to the JP.

A standard is the active ingredient in raw form which has been qualified to be used for comparison. You basically make a concentration of the raw form that resembles what you expect to be in a tablet. The tablet is broken down and compared to your standard concentration to confirm that the amount of active ingredient in your tablet is what it is supposed to be. If you have a 10 milligram (mg) tablet of Lipitor, you want 10 mg of Atorvastin in that tablet and not 9.5 mg.

The Monopoly

This is where the USP has the monopoly. I can’t go to another vendor or company to buy standards. There is no way to compete against the USP. If the FDA found out that testing was performed without a USP standard, it would be considered null and void and fines would come. One can imagine the premium paid to buy the standards since there is no competition.

The USP doesn’t manufacture anything. They outsource almost everything they do. The standards are manufactured elsewhere, new active ingredients testing is performed by other labs. They do have a large technical staff on hand for troubleshooting. On top of that, they have to spend every dime they make since they are a non-profit. In addition, the USP regulates the equipment used for drug testing of any pharmaceutical ingredient, nutritional supplement or food component. Cars have certain US regulations that have to be followed when made, scientific laboratory equipment also have certain regulations and techniques that have to be abided by. All this regulation is a good thing for the industry to make sure contaminants don’t end up in the drug pipeline. This ensures that when you take a prescription drug, it is chemically the same no matter where it came from and it adheres to the drug release criteria.

Have you ever worried about drugs manufactured outside the US?