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High Utilization Seen as GMP Issue Behind Cancer Drug Shortages

 
• By Bowman Cox

A lack of manufacturing capacity blamed for sterile injectable oncology drug shortages can be viewed as a GMP compliance issue, FDA official says, pointing to Section 211 process validation requirements. HHS analysis links the shortages to excessive utilization rates at generics firms.

As FDA responds to a spate of drug shortages, there is talk within the agency about treating the underlying failure of the pharmaceutical industry to adequately increase production capacity as a GMP issue, an FDA official told the Interphex conference in New York.

It’s a discussion that gives quality managers a reason to monitor utilization rates and

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