Setting the Standard - Pharmaceutical Executive


Setting the Standard

Pharmaceutical Executive

First of all, USP has seen an explosion in terms of its international reference-standard sales. If it's not already, most of our reference-standard sales will come from outside this country.

Now, you might say to yourself, why is that? Well, first of all, I think both our documentary standards and our reference standards are good. Second of all, the ICH [International Conference on Harmonization] gave tremendous impetus to specifications, testing to specifications, and impurity testing. The ICH Q3C procedures focused a lot on impurities and the drug substance, then Q3A focused on the drug substance, and Q3B focused on the drug product in terms of impurities, and that leads to additional testing and additional manufacturing controls. So all of this has enhanced our products and services, not only nationally, but internationally.

Now, of course, there's another reason, which is that people want to get into the very lucrative US market. And while USP is not a gatekeeper, we're a facilitator in certain areas—namely the quality areas. It's a very strong role for us. I'd like it to expand, and certainly, we want to make sure we work appropriately with FDA as a facilitator.

What are the issues in harmonization?

I can't say that we're seeing a lot of ground swell of enthusiasm for improvement. People are happy with the way it is. We can propose improvements, but people have to be willing to accept them.

Why are countries unwilling to harmonize?

Sometimes, I'm just mystified. There's robust support for excipient harmonization, and that makes a lot of sense to me. But when you get into the nonexcipient general chapters and the drug substance, we were told quite clearly that the harmonization and the compendia connected with ICH should not focus on the drug substance. I don't know why. I would say, right now, harmonization will proceed at a very slow pace, unless something is done.

Do we have de facto harmonization with, say, Northern Europe or Canada?

Let's just say you're an excipient manufacturer. You may have to satisfy 40 compendial standards. The classic example is sodium chloride, where there are 50 tests with different procedures and different acceptance criteria. That's nightmarish. What a sodium chloride manufacturer could do is just take all the tests and create a private monograph that meets the most restrictive acceptance criteria. But that's very burdensome.

We want to work throughout the world partnering wherever we can to advance the public health mission connected with those documentary and physical standards, which, at the end of the day, relate to the quality of medicines and their safety, efficacy, and use.

We've been in a lot of places in the world through what we call our stakeholder forums. But the next step after a stakeholder forum is actually to set up a site. Our first site was in Hyderabad, India. That was very carefully considered. India is making a lot of drugs and dosage forms, and they're also coming into the United States in a big way. Hyderabad was chosen because it's a locus for a lot of bulk-drug manufacturing, but also dosage-form manufacturing. It's also in the heart of India's "Genome Valley."

So that office interacts with manufacturers and regulatory officials in India?

Right. We try to have very good relationships with the government ministries, the government regulatory agency, and the Indian pharmacopeia. I'll probably go back there over the summer to see how I can build some of those linkages. Our second site will be in Shanghai for much the same reason as India.

People are predicting that in the next five years up to 80 percent of our bulks could be coming from either India or China. Now why wouldn't we be there? I could have set some of these sites up in Howard County [in Maryland]. But we're not going to get 80 percent of our bulks from Howard County.


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