What is in this article?:
- Recent GMP audits of supplement makers reveal common compliance problems
- If it was not written down, it did not happen
Good Manufacturing Practices inspections are ramping up—and so are the violations. In 2010, FDA discovered more instances of noncompliance by supplement companies than expected. The good news? These findings offer others guidance on how to ensure GMP compliance.
Over the last several years, the U.S. Food and Drug Administration (FDA) has called out hundreds of adulterated dietary supplements for containing drugs such as sildenafil (Viagra) for sexual enhancement or sibutramine for weight loss. But this is not the only quality problem facing the supplement industry. Through its audits of supplement manufacturers, the FDA has pinpointed another kind of adulteration that is pervading industry: companies not meeting supplement Good Manufacturing Practices (GMPs).
According to FDA's Brad Williams, 25 percent of the dietary supplements manufacturers inspected by the agency in 2010 had significant GMP deficiencies. These deficiencies occurred in small, medium and large companies, said Williams, who is the consumer safety officer for the FDA's Division of Dietary Supplement Programs.
Problems with GMP compliance can lead to a product being labeled as adulterated. According to the Dietary Supplement Health and Education Act (DSHEA) of 1994, a dietary supplement will be named adulterated "if it has been prepared, packed or held under conditions that do not meet current good manufacturing practice regulations." The Final Rule on GMPs was issued in 2007; and since then, GMP audits have increased each year. FDA has completed 66 GMP inspections so far in fiscal 2011 and 84 total inspections in 2010.
The problems being identified by FDA are many. Recent GMP audits reveal companies' failure to:
- Perform required identity testing on incoming dietary ingredients
- Set appropriate specifications for components and dietary supplements
- Adopt written procedures as required in the rule
- Prepare and follow Master Manufacturing Records and/or Batch Production Records for manufacture of dietary supplements
- Provide quality personnel to conduct required material reviews and make disposition decisions
Companies that do not comply with GMPs could meet serious action from FDA beginning with a warning letter. A company typically must respond within 15 days to FDA by outlining a resolution to the violation. If the resolution is not recognized as sufficient, product seizure or an injunction could prevent companies from continuing to produce until the violations have been corrected.
"FDA takes compliance with the dietary supplement GMPs seriously and expects the industry to do the same," cautioned Williams.