Sean Moloughney06.01.10
The month of June often conjures a variety of pleasant connotations, including the end of a school year and warmer weather, depending on your geographical location. Here on the east coast, we’ve emerged from a stormy winter and settled into a more moderate season—for the time being at least. But for the supplement industry, there could be another storm on the horizon, and school is still in session.
June 25th marks the final GMP compliance date for companies that manufacture, package, label or hold dietary supplements, including those employing fewer than 20 full-time employees. If your company falls into this category, before you start having heart palpitations, take a deep breath, and let’s get some perspective from an FDA insider.
Carl Reynolds, senior adviser in the division of dietary supplement programs at FDA’s Center for Food Safety and Applied Nutrition (CFSAN), recently offered an overview of GMP inspections from FDA’s vantage point while at the SupplySide East tradeshow in Secaucus, NJ.
In the summer of 2008 FDA began conducting inspections, completing 12 in the 2008 fiscal year and 28 in the 2009 fiscal year. According to Mr. Reynolds, it’s still too early to provide reliable trending data. However, he didn’t shy from offering a few thoughts and recommendations based on what he’s seen so far.
“There’s going to be a culture change,” Mr. Reynolds predicted, looking like a schoolteacher ready to lay down the law with his students. Noting that inspectors have seen insect and rodent infestation in raw material storage areas in at least one facility, he said plainly, “It surprises me.” He then paused for a moment, surveying the audience as if to make any bad actors in attendance sweat it out and think about what they’ve done.
Mr. Reynolds said he’s noticed a lack of identity testing, cautioning that procedures “need to be appropriate for the material you’re testing for.” According to FDA, for a dietary ingredient, a firm must, at minimum, conduct an appropriate identity test on the dietary ingredient, but may rely on a Certificate of Analysis for other specifications if the vendor has been qualified. The process for qualifying vendors should also be thoroughly documented.
Mr. Reynolds raised other issues that include: a lack of authenticated reference and testing standards, inadequate quality control activities, inadequate training of personnel and incomplete standard operating procedures (SOPs).
“Some people are buying SOPs already written,” he said. “You need to add to them or modify them to fit your particular activities. They need to be complete and understandable, and signed by the quality unit. These documents are not static. It is not wrong to make changes as long as you go through the documented procedure.”
Mr. Reynolds also came across incomplete master manufacturing records and batch records. “They don’t contain all the information, if they even exist. The master manufacturing record needs to be the controlling document, not the batch record.”
The GMP regulation is complex, detailed and lengthy—and may seem cumbersome or overwhelming for those who aren’t well versed in the language. Even Mr. Reynolds said he wasn’t able to cover all areas of interest in one 50-minute time period. But like any good teacher, FDA has been willing to work with the industry to provide guidance on what’s expected from companies as they work toward compliance.
So if you still feel unprepared, it’s not too late to ask questions and cram for this exam, because it will be coming, eventually, according to Mr. Reynolds. For now, the final word on GMP records and documentation: “If it isn’t written down, it didn’t happen.”
