FDA GMP Inspections Find QC Training Lacking

By June 2010, all dietary supplement manufacturers must be in compliance with federal GMPs (good manufacturing practices). However, many companies remain far behind in implementation, according to Carl Reynolds, senior advisor in the Division of Dietary Supplement Programs at FDA's Center for Food Safety and Nutrition (CFSAN). In his presentation at SupplySide East 2010, Reynolds ran through a large list of concerns that FDA inspectors are seeing on their visits to manufacturers. Among those he cited were a lack of master batch and manufacturing records; an alarming lapse in insect and rodent control; failure to create and implement corrective action plans; inadequate operating procedures (i.e., if the procedure is on cleaning equipment, it should state the product used for cleaning); unacceptable allowance of entities other than QC to issue final release of product; inadequate quality control (QC) personnel training; and failure to collect representative samples of ingredients and products.

"This role puts a lot of emphasis on quality control activity ... and some quality control personnel have not been adequately trained on their responsibilities," Reynolds said. He used the issue of representative sampling to illustrate the point. If 10 containers of a particular product arrive at a company, "it is not acceptable to open one container and take a sample. It must be representative to the lot." Further, he said some companies are doing representative sampling of dietary ingredients, but not other inactive compounds that may be used in production and formulation. "That's not acceptable," he said. "It must be representative for all."