Wednesday, May 20, 2009

Considering the Source – WHO cracks down on GMPs of their suppliers BIG and small.

The finished product is only as good as the sum of its parts.

We are seeing a trend of stricter enforcement of Good Manufacturing Practices (GMPs). Even larger pharmaceutical manufacturers are feeling the pinch as the quality of their pharmaceutical ingredient suppliers are put to the test.

Recently The World Health Organization (WHO) announced they would suspend tuberculosis drugs from Wyeth Pakistan because they questioned the quality of the drug. Their shift in trust of the finish product stemmed from a switch in suppliers for one of its ingredients. The outsourcing of ingredients has become a challenge for manufacturers because consistent suppliers are not always accessible.

A summary of the article appears below and you can view the entire article at American Enterprise Institute website at:

Consider the Source
(Tuesday, May 19, 2009; by Roger Bate; Journal of American Enterprise Institute)
A recent case reveals that it is not only generic firms from middle-income countries that have problems with good manufacturing practice.

The World Health Organization (WHO) late last month announced it was suspending approval for all tuberculosis drugs produced by the Pakistan plant of a subsidiary of the U.S. drug company Wyeth, because it was “no longer assured of the quality of the product.” The drugs had been approved by WHO, which UN agencies, national governments, and other international organizations use to guide the procurement of millions of dollars of HIV/AIDS, malaria, and tuberculosis drugs for the world’s poorest patients.

According to a letter to the company posted on WHO’s website, Wyeth failed to inform WHO that it had changed suppliers for some of its active pharmaceutical ingredients (API) and had altered storage conditions. “They had been informed on a number of occasions”—directly and through communications to all suppliers—“about the importance of informing WHO,” Matthias Stahl, medical officer in charge of assessments at WHO’s drug approval program, told us. WHO’s most recent inspection of the site, in 2005, identified serious noncompliance with Good Manufacturing Practice (GMP), and since that time only limited corrective action had been taken.

The case reveals that it is not only generic firms from middle-income countries that have problems with GMP, as we have previously discussed regarding India’s largest drug company Ranbaxy. Wyeth and Ranbaxy, which are both reputable companies, will probably resolve their particular problems soon. But as more firms source more intermediate chemicals and API from myriad countries, we may be seeing the beginning of a trend.

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