What Third-party Inspections Mean to You
by Jim Lassiter
Your company wants to ensure it is complying with federal regulations governing the manufacture and/or distribution of dietary supplements. Representatives from the Food and Drug Administration (FDA) dont really have the time to stop by all that often. What should you do?
One option is to call the local FDA office and request inspectors come out and look around. While a simple solution, the results would likely do more harm than good to the business. Dependent upon the degree to which the facilities, products and operations are evolving toward compliance with current and upcoming regulations, your company may find the inspectors findings and actions to be more of a burden than an assist.
A simpler choice is to contract with an outside entity to perform the evaluation. The benefits of this approach are many and the downside far less than having the government do the job. Moreover, such an inspection can be positioned in a most favorable light when FDA does come a-calling. An inspection by a third party does notrepeat NOT replace an FDA inspection. FDA inspectors may come along at any point in time to inspect your facilities, carrying with them the full weight of the law and regulations that exist. However, using a third party to inspect and potentially certify your operation yields many positive outcomes.
The range of third-party inspectors is seemingly broad but not too many in number. There are individual consulting organizations that can perform the task along with well-recognized companies and even a trade association that inspect operations with the added benefit of potentially certifying operations. The first step is determining the desired outcome of an inspection. One goal is obtaining information concerning what changes may be needed in order to come closer to compliance with existing regulations.
Another is relying on the organization to inspect your operation and products in an effort to anticipate the forthcoming final regulations on GMPs (good manufacturing practices) for dietary supplements, which are anticipated later this year. Or the goal may be to adjust operations to obtain certification from a third-party inspector to distinguish your products in the marketplace based on value added through demonstration of quality. After determining expectations for the third-party inspection, the options narrow.
In this article, the focus is on two organizations that offer not only inspection but also certification to an established set of standards. This higher standard for outside inspectionsowing to the issuance of a certificationcan be of notable benefit. Two such organizations that offer certification and make available their seal of approval are NSF International and the National Nutritional Foods Association (NNFA). In either case, inspectors from the organization come to your facility (at an appointed time established between you and the third party rather than FDAs more random inspection visits) to evaluate the facility, the operation and the products. These inspectors use well-documented, established standards for conformance. The bases for these inspections differ only slightly from one to the other. While the result of the certification cannot absolutely assure regulatory compliancesince these organizations are not official arms of FDAthe results do provide some assurance of quality operations.
NNFA inspectors apply the associations GMPs in reviewing everything a company does in the manufacture and/or distribution of product. These GMPs are not official regulations; but, they do come from the regulatory process itself. NNFA was a contributor to the so-called industry document presented to FDA during the first years post-DSHEA (the Dietary Supplement Health & Education Act of 1994). This industry document was included in the Advanced Notice of Proposed Rulemaking (ANPR) concerning dietary supplement GMPs issued by FDA in 1997. The standards established in the industry document were (with very few differences) incorporated directly in the NNFA GMPs. FDA issued its proposed rule (the next step in the rulemaking process) in 2003. The proposed rule does not so much resemble the industry document as it does present FDAs thoughts on what GMPs for dietary supplements should be. The comment period for the proposed rule closed in August 2003 and NNFA (along with the American Herbal Products Association and the Council for Responsible Nutrition) later issued a unified response that detailed what the GMPs should look like from an industry perspective using FDAs proposed rule as a starting point. This document now serves as the current basis for NNFAs GMPs. By mirroring the proposed rule, NNFAs inspectors apply standards that may well be incorporated into the final rule on GMPs. While the use of this standard is not a guarantee of future compliance, it does offer insights as to what changes may be necessary to comply with the Final Rule.
The other certifying organization discussed here is NSF International. This dedicated inspection/evaluation organization has dedicated a portion of its efforts specifically to the dietary supplement industry. NSF has a long record of accomplishment in inspecting and certifying products and facilities across a number of different industries with great success. Its involvement with the dietary supplement industry has meant a significant increase in the awareness of what good practices and products are, along with providing clients with a solid understanding of the concept of conformance to standards. The current inspection criteria employed by NSF comes from FDAs proposed rule for dietary supplement GMPs and emphasizes the testing and laboratory control aspects the proposed rule presented. Further, NSF can inspect laboratory facilities independently to assess conformance with the present ISO guidelines applicable to laboratories (known as the 17.025 certification). Obtaining NSF certification is not a simple task. A preliminary inspection results in the issuance of a series of needed corrections in the organization, procedures and possibly even products.
Inspectors follow a consistent checklist that covers procedures, products and facility details, and result in revelation of areas within the operation that likely were not previously considered deficient. With the preliminary inspection findings in hand, a company moves to implement the suggested changes. Without this implementation, you will not receive the certification. Follow-up inspection by NSF includes a review of the previous findings, re-inspection of those areas to assure effective changes occurred and the re-application of the original checklist inspection to see if anything else requires address. While this seems to be a rigorous inspection scheme, this regimen comes from a long history of success by NSF in the area of inspection and certification.
Now for the bad news. Certification by NNFA or NSF is not a guarantee that FDA will find an operation in compliance. FDA spoke publicly about the matter of third-party inspections in discussing the proposed rule and pointedly affirmed there is no substitute for FDA inspection. The agency did allow that third-party inspection by well-recognized organizations is of benefit. Nevertheless, this is no guarantee that when the FDA inspector comes to the door, he will find a certified operation fully compliant. When the final rule on dietary supplement GMPs is published, companies will need to know all there is to know about what it takes to achieve compliance. Rest assured that NNFA, NSF and a host of other outside companies, consultants and organizations will come to understand the final rule very quickly. These companies can help you determine the degree of compliance you have without the concerns of the regulatory hammer immediately falling. The compliance period (the time before FDA fully enforces its final standards) is one year from date of publication of the final rule for large companies and three years for small ones. After that, FDA will exercise its full authority to enforce the regulations and act with the force of law if anything is amiss.
So, what are the benefits of third-party inspection? The answers are simultaneously real and speculative. Inspection of facilities and products definitely affords a greater degree of assurance that those products meet a specific quality standard. This alone is beneficial. Third-party inspections can also help prepare for FDA inspections, which will ultimately come at some point in the future. A larger opportunity for gaining benefit is speculative. If FDA were approached formally to discuss the applicability and meaning of third-party evaluations, the focus should be on how these third-party inspections can benefit both FDA and industry. How would that work? Consider the following:
FDA cannot authorize third-party inspections of facilities nor can it accept the third-party findings as demonstration of conformance to regulations. While other countries do allow this (most notably Australia, which authorizes inspectors in other countries to serve as if they were members of Australias Therapeutic Goods Administration) FDA cannot. However, FDA could see fit to ease its own inspection burden by acknowledging third-party inspections. In other words, FDAs acknowledgement (not acceptance) of the efforts of third party inspections allows the agency to utilize its limited resources more efficiently. FDA could therefore prioritize its inspection schedule to focus first on companies that have not undergone these unofficial reviews by accepted third parties. Thus, a company that has undergone third-party inspection has additional assurance not only of the overall quality of its products but also the additional assurance that FDAs inspection may be a little less imminent. The company also receives some comfort in the knowledge that when FDA does come, it is far better prepared to survive the inspection.
This approach allows FDA more efficient enforcement of its regulations and relieves the agency of the burden to demand increased resources to accomplish its mandate. FDA would routinely receive a listing of companies successfully employing the recognized third-party inspectors and could focus its efforts more appropriately. This bit of thinking outside the box allows inspections by third parties to be more meaningful to the industry and to FDA. Encouraging companies to use third-party inspections increases the likelihood that FDA meets its objectives concerning implementing quality manufacturing standards for dietary supplements. While such an agreement cannot make third-party inspections a replacement for FDA inspections, it would provide the industry, the regulatory agency and the consumer with greater assurance that the products offered by the dietary supplement industry are of the quality desired by all.
Jim Lassiter has more than 25 years of experience in regulatory affairs and is currently director of consulting and regulatory services at ChromaDex Inc., a global provider of high purity reference standards and research, regulatory and product consulting services. Lassiter can be contacted at JimL@ChromaDex.com.