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cGMP Compliance: Why It's Essential for Contract Manufacturers

cGMP Expertise

Contract manufacturers cannot afford to disregard cGMPs (current good manufacturing practices) for dietary supplements.

FDA has underscored it is concerned about the relatively high rate of noncompliance, as illustrated by the number of warning letters that are posted online each month.  

There is little excuse for noncompliance. If you don't have in-house expertise, a number of consultants, lawyers and other experts are available to help brand owners understand what is required under the regulations.

Don't take a haphazard approach to cGMPs in the hope that you won't get caught because FDA data indicates the agency has increased its number of inspections. Distributors who outsource their manufacturing to a contractor also should understand what FDA has noted time and again: they are responsible for complying with cGMPs even though another company is manufacturing their products.

Regulatory experts say contract manufacturers and their customers should consider retaining a third-party auditor such as NSF International so they are prepared for the inevitable FDA inspection of a manufacturing facility.

Third-party audits and certifications have increased over the years, possibly reflecting a growing commitment to compliance with the regulations. Third-party certifications also are beneficial because they can be used as a marketing tool to help distinguish a manufacturer.

But don't place too much reliance on third-party audits and certifications. FDA is not bound by these findings, and it has found problems at a manufacturing facility even after a third party has certified the facility as being compliant with cGMPs.

Supplement brand owners should be able to rely on their contract manufacturers for cGMP compliance because they are bound by the regulations as well. But don't blindly trust your partners. Government rarely treats ignorance as a defense.

For more details on cGMP compliance as a contract manufacturer, check out the INSIDER Report, "cGMP Expertise: Why It's Essential for Contract Manufacturers."  

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