Third-Party GMP Certifications
The argument for being GMP-compliant before FDAs GMPs go into effect
by Susan Colebank
The matter of good manufacturing practices (GMPs) has become a popular topic of discussion at trade shows and industry conferences, and in trade magazines, since the Food and Drug Administration (FDA) published its proposed rule for GMPs in March. With the federal GMPs only a few years away from applying to every manufacturer in the dietary supplement industry, life has gotten more complicated. While there will be one set of nationally recognized standards, there are currently multiple GMP standards being offered by various organizations, none of which are endorsed by FDA as a GMP certifier. But is this really a problem?
According to Christine Taylor, Ph.D., the director of the Office of Nutritional Products, Labeling and Dietary Supplements for the Center for Food Safety and Applied Nutrition (CFSAN), To the extent the industry is able to find creative or helpful ways to make GMPs easier to handle, were definitely supportive of. I think for some companies, going to third parties is totally workable for them, while others feel they may not need that. Our position is that GMPs are out there for all to follow, and to the extent that third parties or any other system are out there is helpful in making all this happen, FDA believes that as long as theyre following [the proposed] GMPs, its a good thing.
Currently, there are three well-known GMP certifiers in the dietary supplement industry. NSF International, the National Nutritional Foods Association (NNFA) and the U.S. Pharmacopeia (USP) offer programs that deliver the same end resultsquality control procedures for the dietary supplement manufacturer and peace of mind for the consumer.
Why would a company want to spend the money with NNFA, NSF or USP to become GMP-compliant when 1) it is still uncertain if FDA will accept such certifications, and 2) the final GMP rule has not been nailed down?
Manufacturers should make a concerted effort to become familiar with the proposed dietary supplement GMPs, said Kathleen Pompliano, NSFs new business development manager. The GMPs are not prescriptive in how to implement a program, therefore self-audits and/or outside consultancy can help identify areas of possible non-compliance and facilitate implementing a strategy in accordance with a companys risk management practices that is economically feasible.
NSF offers product-specific certification and GMP registration for production facilities. NSF also offers a third-party vendor quality audit program for verification of suppliers products, in addition to testing and laboratory services. Registration or certification by an accredited thirdparty provides additional credibility and a competitive marketing advantage, Pompliano said.
NSF has a strategic alliance with NNFA, in which NNFA has licensed its GMP program materials to NSF. NNFA offers a GMP Certification Program based on third-party inspections of member suppliers and comprehensive audits of GMP programs in the areas of personnel, plant and grounds, sanitation, equipment, quality operations, production and process controls, and warehouse, distribution and post-distribution practices.
According to Phil Harvey, Ph.D., chief science officer, Those following NNFA GMPs wont be 100-percent compliant with FDAs proposed GMPs, but our GMPs will put manufacturers way ahead of the game. They may need to fine tune some areas, such as the testing area that NNFA is not so strict on compared to FDAs.
Working with an organization such as NNFA to certify a manufacturer as GMP-compliant indicates a third party has come in and, aside from ensuring a company is compliant with current GMP requirements, that an independent party was able to give the company confidence they are meeting FDA standards. It can also identify weak areas a company needs to address. They may think they are in compliance when theyre not, Harvey said. The most important aspect is that it allows a company to be proactive.
GMPs are just one part of USPs Dietary Supplement Verification Program (DSVP). The DSVP addresses if a product contains what is on the label, if it is free from harmful contaminants, if the product is bioavailable, and if it was produced using GMPs.
According to USP, another downfall of not being certified under current GMPs is that when a company does not have a written record as to what goes in from batch to batch, each batchs consistency and quality may be affected.
If a company has a good quality control system in place, the products it makes will be of consistent quality, said V. Srini Srinivasan, vice president of the DSVP. Things can go wrong, but at least when things go wrong in a GMP-compliant facility, you will know how to fix them quickly. You need to invest the money in building up a quality system, but you recover the money in no time since having quality control procedures in place can avert costly manufacturing mistakes and legal actions in the future.
The final word on the validity of third-party GMP certifiers is, of course, FDA. If you read the proposal, we havent proposed that third parties would be inspecting facilities, Taylor explained. But companies [may] get some comfort out of hiring others who they feel to be experts to help them.
Harvey said NNFA would be attempting to aggressively lobby FDA to accept third-party certification. That would be a real benefit to our program, so that if a company is NNFA-certified, FDA would recognize and accept the fact they meet GMPs based on a third-party evaluation, like the U.S. Department of Agricultures take on allowing third-party, non-government organic certifiers.
Is FDA receptive to this idea? Not at this point. Well have to wait once the comments have been submitted and strong lobbying has occurred, Harvey said. But this is the way to work with FDA, because the agencys not going to come up with ittheyre just going to say Hey, this is the law, and well follow up when we can.
On a final, hopeful note, Taylor added, We will consider all comments. Hopefully, those who have given a comment have given a rationale and helped to describe it so we can better evaluate their comments.
|NSF Promotes Functional Food and Beverage
NSF is now offering a Functional Foods and Beverages Certification Program, designed to give non-biased, third-party certification that ensures a product does not contain contaminants, does comply with nutrition labeling requirements and has been manufactured in accordance with current GMPs for quality, safety and sanitation.