A March warning letter to Warner Chilcott addressing the production of its norethindrone/ethinyl estradiol (EE) contraceptive Ovcon in Puerto Rico highlights FDA’s growing concern that design, development and technical knowledge is not being adequately transferred when products are shifted from one manufacturer to another.
In Warner Chilcott’s case, FDA traced a five-year pattern of Ovcon not meeting its EE stability specification following the product’s 2005 acquisition to the failure of the firm’s quality unit to “effectively evaluate available developmental and technical transfer data that may impact the quality attributes of products” that it manufactures.
It is essential, the letter stresses, “that the quality unit review relevant process design data including process knowledge and understanding obtained during technical transfer activities in order to assure an overall understanding of the process impact on the quality attributes (e.g., assay) of your product.”
FDA’s San Juan District Director Maridalia Torres directs Warner Chilcott CEO Roger Boissonault to provide “appropriate evidence” in the company’s response to the letter that: ● the quality system at the Fajardo, PR facility has been changed ● the steps taken to ensure that the quality unit personnel understand their responsibilities have been identified, and ● the QU staff have “the necessary scientific and technical qualifications and the appropriate authorities to effectively execute their quality functions to ensure” that the plant’s drug products are safe and effective.
The Warner Chilcott letter accompanied a bolus of six warning letters issued to foreign firms during a two week period in late February to early March (IPQ “The News in Depth” May 1, 2012).
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