Are Your Labs GMP Compliant?

LAS VEGASEven supplement companies that use third-party testing labs to ensure product safety and efficacy must ensure cGMPs (current good manufacturing practices) are followed throughout the entire supply chain. Therefore, a brand owner should choose a  testing lab that follows standard operating procedures (SOPs) and systems that are consistent with FDA expectations, according to Darryl Sullivan, director of scientific and regulatory affairs, Covance Laboratories, at SupplySide West 2012.

The manufacturer and the lab also need to have a high level of communication and documentation because as Sullivan reminded, both parties are responsible for GMP compliance. The better the documentation, the easy it is for FDA auditors, making it more likely a company will not receive a 483 form indicating a GMP violation.

Under GMPs, tests used for supplement specifications must be "appropriate, scientifically valid methods." He explained the best ways to show testing methods follow GMPs is to use methods validated by AOAC or ISO, which demonstrate precision and accuracy.

However, not all dietary ingredients have AOAC or ISO testing methods. In these cases, its best to use a lab that has a third-party validated method. Sullivan explained a method must be accurate, precise and specific to be a "scientifically valid." The method should also separate passing and failing materials, identify adulteration and combine multiple techniques to qualify raw materials.

Every lot of raw materials used for supplement manufacturing must be tested for identification; tests can be organoleptic, macroscopic or microscopic examinations, or chemical methods. Nonactive, or inert ingredients, don't have to be tested if the supplier is prequalified and submits a certificate of analysis (CoA), Sullivan said.

On the other end of manufacturing, Sullivan pointed out that every batch of finished products must also be tested for labels, nutrient content and expiration date.

Sullivan also noted FDA auditors are used to reviewing food and pharmaceutical labs (in fact, the agency has yet to audit a supplement contract lab), so companies would be wise to choose contract labs that are familiar with FDA good laboratory practices (GLP) and pharmaceutical GMPs.

FDA will also be reviewing lab training files, Sullivan added, so he said lab techs should b sure to complete, sign and date regular trainings.

In the talk, Sullivan also explained which types of methods are likely to easily pass GMP inspection, and which ones take extra precaution to ensure all regulations are met.

See the entire presentation, "How to Prepare for an FDA Audit Laboratory Compliance with Dietary Supplement GMPs," by purchasing the SupplySide West 2012 Natural Products INSIDER Premium Education Package DVD in the SupplySide Store.