The FDA's new current good manufacturing practices (CGMPs) for dietary supplements are rich in requirements related to packaging and labeling.
A decade in the making, the CGMP rule, compliance with which will be phased in according to size of company, sets minimum standards for assembly-line contact surfaces, packaging and labeling equipment, inspection of packaging received from suppliers, relations with third-party packagers, personnel hygiene on the packaging line and much more, all within the context of forcing the industry—some of which may already be in compliance—to adopt the kind of CGMPs that the FDA has prescribed for food and drugs.
Paul Bolar, vice president of regulatory affairs for Pharmavite LLC, says larger companies are probably pretty much in "basic" compliance already with the packaging and labeling requirements. He explains that inspection of packaging when it is received from suppliers and after it comes off the production line is "not unusual by any means." He adds, "Companies that use electronic controls will be in the best shape."
But smaller companies may have considerable work and expense in front of them, though they will have a longer lead-time to comply. The compliance date is June 25, 2008, for the largest companies; one year later for companies with fewer than 500 but at least 20 or more full-time equivalent employees; and one year after that, or June 25, 2010, for companies with fewer than 20 full-time equivalent employees.
Inspection of incoming containers
As an example of the new requirements, and some of their esoteric byways, one only need look at the requirement that a company "visually inspect each immediate container or grouping of immediate containers in a shipment you receive for appropriate content label, container damage, or broken seals to determine whether the container condition may have resulted in contamination or deterioration of the components."
The adjective "immediate" was added to the final rule to send a signal, apparently, though the FDA does not say so explicitly, that secondary packaging is not subject to the rule. Moreover, the FDA also added the words "you receive" to differentiate packaging a company obtains from a supplier, which is covered under the rule, from packaging the company may manufacture itself, which is not covered. If that visual inspection turns up problems with the packaging, the packaging must be tested.... Read more
By Stephen Barlas, Contributing Editor
