FDA warns Sandoz on unvalidated manufacturing

By Gareth Macdonald

- Last updated on GMT

Related tags Astrazeneca Hypertension

The FDA says that Sandoz, the generics arm of Swiss drug major Novartis, failed to validate manufacturing processes used to produce metoprolol succinate ER tablets at its plant in Wilson, North Carolina.

In its letter to Sandoz CEO Bernhard Hampl the Food and Drug Administration (FDA) said that a March inspection of the facility had revealed significant deviations from good manufacturing practice (GMP) standards.

The agency said that Sandoz had used data from unrelated batches of the drug to validate required content uniformity and dissolution tests and added that it had failed to record tablet press speed and hardness results in production records.

The FDA also identified several documentation issues associated with the manufacture of 25 and 50mg dosages of the hypertension drug, which is a generic, extended-release version of AstraZeneca’s Toprol XL.

The FDA said that it is concerned “that the problems noted in the metoprolol validations could be indicative of problems and poor decisions made with other product validations​.”

The agency suggested that Sandoz implement the Trackwise automated investigation management system that is already in place at many of the firm’s other manufacturing facilities.

In a press statement Sandoz said: “The FDA Warning Letter is primarily related to concerns with documentation, validation controls and investigations. Sandoz is continuing to collaborate with the FDA to ensure all concerns are resolved promptly and to the full satisfaction of the Agency. All products released and distributed to the market met all specifications.”

Sandoz communications officer Chris Lewis told in-PharmaTechnologist that the firm has:initiated corrective actions including a comprehensive quality improvement plan for the Wilson plant and is currently reviewing all related documentation and practices​.

Lewis added that: “This quality improvement plan will strengthen existing processes and controls, and comprehensively address all of FDA’s concerns. Sandoz is committed to ensuring our products are safe and effective and meet the highest quality standards​. “

Competition among generic metoprolol producers is fierce as firms aim to secure a slice of the Toprol market. As a result sales of the branded drug generated just $206m (€258m) for AstraZeneca in the second quarter, down from $457m in the comparable period last year.

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