Difficulty Identifying Experts Seen as a Factor in Poor Investigations
This article was originally published in The Gold Sheet
Pharmaceutical enterprises have become so complex that some sites with quality problems can’t find the root cause because they no longer know who their key experts are or where to find them, one industry expert says. Regardless of why they happen, inadequate investigations continue to be the most frequently cited GMP concern in FDA warning letters year after year.
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Continued problems at a Portuguese plant have prompted the U.S. FDA to urge Hikma to make a global reassessment of its manufacturing processes.
Injectables eclipsed oral solids as 2012 generated the fourth-most recalls ever. Contamination played a major role, particularly in generating several massive recalls at compounding pharmacies, while there were also contraceptive packaging snafus, problems in confronting tablet mix-ups and other issues that generated drug recalls last year.
FDA’s aggressive enforcement against pharmaceutical manufacturers for GMP violations continued in the first half of the year through its use of warning letters. Inadequate contamination controls was a common deficiency found in eight of the 18 drug GMP warning letters, failure to investigate out-of-specification results continues to be the most frequent GMP deficiency in warning letters, and cites of stability problems are increasing.