One of the durable aspects of the GMP compliance picture has been the repeated citation for firms that don’t have adequate Standard Operation Procedures (SOPs), that have failed to set adequate specifications and/or lack adequate Master Manufacturing Records (MMRs) or batch records. At a recent industry meeting, Cara Welch, PhD, who directs FDA’s Division of Dietary Supplement Programs, said that non compliance as measured by the number of Official Action Indicated citations (OAIs) hovers at about 25-28% industry wide, and has not been improving nearly fast enough.
She did say that that figure conceals within in it an improvement; the very largest firms, those with more than 500 employees, are now in full compliance as far as OAIs are concerned, with 0% OAIs on inspections in the most recent data period. The middle sized and smallest firms still struggle, Welch said, and while there may have been some improvement, having most of the MMRs required yet lacking a few to cite one example is still recorded as a violation in official compliance figures.
Ditching the clipboards
Many of the smallest companies and even some of the medium sized ones still do a lot of their quality control work on clipboards with paper forms, said Instant GMP director of sales Robert Pochadt, who spoke with NutraIngredients-USA at the recent Supply Side West trade show in Las Vegas, NV. It adds up to extra man hours and more room for error. Switching to an automated system can not only save time and money but can also be an opportunity to improve the overall quality of a company’s documentation procedures, he said.
“The folks that want to make a move to an automated environment keep coming to us,” Pochadt said. “When people are looking for SOPs what they are looking for is a good, accurate interpretation of the FDA guidelines. We emphasize that they should be looking for an SOP that is a living document and that provides meaningful action steps toward compliance.”
Pochadt said the choice of a production management system should be taken with an eye toward compliance with FDA’s data capture requirements. There are a plethora of such systems on the market, and some companies have built up systems ad hoc with one platform managing the warehouse, another dealing with the manufacturing floor, etc., all of which makes a simple plug-and-play documentation add on difficult in some cases. Pochadt said his company takes this integration problem on a case-by-case basis and can successfully integrate the documentation software with many existing platforms. He said Instant GMP is planning a more comprehensive integration approach for launch next year.