Other Than The Fact That We Have No Equipment For Drug Testing, Our Lab Is Great
March 26th, 2012 // 12:02 pm @ jmpickett
When it comes to manufacturing problems, some drugmakers experience lapses. Others have oversights. Then, there are those such as Laboratorios Jaloma, which lacks a few basics. Such as? Well, the drugmaker, which is based in Guadalajara, México, apparently did not have the equipment needed to actually test its products for release.
This can give a regulator pause. And so the FDA, after conducting an inspection last September, sent a stern warning letter and is maintaining an import alert which, of course, means that Laboratorios Jaloma cannot ship its goods into the US. Although we all know that other types of drugs slip through the border every day, but that is another story.
How bad are procedures at the Guadalajara plant? There was a failure to use a contract lab to conduct tests that cannot be completed on site; there were no lab records to ensure compliance with specifications and standards; there was no written testing program to assess drug stability; and there were no written production and control procedures to ensure stated quality, strength and purity.
To cite one specific example, the FDA wrote that “missing data included, but was not limited to lot numbers of reagents used, documentation of weights and volumes, and dates and signatures of second–person review for accuracy, completeness, and compliance.â€
To put it mildly, this is serious stuff. If a drugmaker lacks the necessary equipment to ensure adequate testing, it follows that back-up data will not exist. Unfortunately, some products may have been available in the US. In addition to coming up with detailed remedial plans, the agency wrote the drugmaker must provide “documentation of testing to determine if all drug products manufactured and shipped to the United States after May 1, 2011 meet required specifications.†In other words, uh-oh.
