Third-Party GMP Certifications

Third-Party GMP Certifications
The argument for being GMP-compliant before FDAs GMPs go intoeffect

by Susan Colebank

The matter of good manufacturing practices (GMPs) has become a popular topicof discussion at trade shows and industry conferences, and in trade magazines,since the Food and Drug Administration (FDA) published its proposed rule forGMPs in March. With the federal GMPs only a few years away from applying toevery manufacturer in the dietary supplement industry, life has gotten morecomplicated. While there will be one set of nationally recognized standards,there are currently multiple GMP standards being offered by variousorganizations, none of which are endorsed by FDA as a GMP certifier. But is thisreally a problem?

According to Christine Taylor, Ph.D., the director of the Office ofNutritional Products, Labeling and Dietary Supplements for the Center for FoodSafety and Applied Nutrition (CFSAN), To the extent the industry is able tofind creative or helpful ways to make GMPs easier to handle, were definitelysupportive of. I think for some companies, going to third parties is totallyworkable for them, while others feel they may not need that. Our position isthat GMPs are out there for all to follow, and to the extent that third partiesor any other system are out there is helpful in making all this happen, FDAbelieves that as long as theyre following [the proposed] GMPs, its a goodthing.

Currently, there are three well-known GMP certifiers in the dietarysupplement industry. NSF International, the National Nutritional FoodsAssociation (NNFA) and the U.S. Pharmacopeia (USP) offer programs that deliverthe same end resultsquality control procedures for the dietary supplementmanufacturer and peace of mind for the consumer.

Why would a company want to spend the money with NNFA, NSF or USP to becomeGMP-compliant when 1) it is still uncertain if FDA will accept suchcertifications, and 2) the final GMP rule has not been nailed down?

Manufacturers should make a concerted effort to become familiar with theproposed dietary supplement GMPs, said Kathleen Pompliano, NSFs newbusiness development manager. The GMPs are not prescriptive in how toimplement a program, therefore self-audits and/or outside consultancy can helpidentify areas of possible non-compliance and facilitate implementing a strategyin accordance with a companys risk management practices that is economicallyfeasible.

NSF offers product-specific certification and GMP registration for productionfacilities. NSF also offers a third-party vendor quality audit program forverification of suppliers products, in addition to testing and laboratoryservices. Registration or certification by an accredited thirdparty providesadditional credibility and a competitive marketing advantage, Pompliano said.

NSF has a strategic alliance with NNFA, in which NNFA has licensed its GMPprogram materials to NSF. NNFA offers a GMP Certification Program based onthird-party inspections of member suppliers and comprehensive audits of GMPprograms in the areas of personnel, plant and grounds, sanitation, equipment,quality operations, production and process controls, and warehouse, distributionand post-distribution practices.

According to Phil Harvey, Ph.D., chief science officer, Those followingNNFA GMPs wont be 100-percent compliant with FDAs proposed GMPs, but ourGMPs will put manufacturers way ahead of the game. They may need to fine tunesome areas, such as the testing area that NNFA is not so strict on compared toFDAs.

Working with an organization such as NNFA to certify a manufacturer as GMP-compliantindicates a third party has come in and, aside from ensuring a company iscompliant with current GMP requirements, that an independent party was able togive the company confidence they are meeting FDA standards. It can also identifyweak areas a company needs to address. They may think they are in compliancewhen theyre not, Harvey said. The most important aspect is that itallows 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 freefrom harmful contaminants, if the product is bioavailable, and if it wasproduced using GMPs.

According to USP, another downfall of not being certified under current GMPsis that when a company does not have a written record as to what goes in frombatch to batch, each batchs consistency and quality may be affected.

If a company has a good quality control system in place, the products itmakes will be of consistent quality, said V. Srini Srinivasan, vice presidentof the DSVP. Things can go wrong, but at least when things go wrong in a GMP-compliantfacility, you will know how to fix them quickly. You need to invest the moneyin building up a quality system, but you recover the money in no time sincehaving quality control procedures in place can avert costly manufacturingmistakes 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 wouldbe inspecting facilities, Taylor explained. But companies [may] get somecomfort out of hiring others who they feel to be experts to help them.

Harvey said NNFA would be attempting to aggressively lobby FDA to acceptthird-party certification. That would be a real benefit to our program, sothat if a company is NNFA-certified, FDA would recognize and accept the factthey meet GMPs based on a third-party evaluation, like the U.S. Department ofAgricultures take on allowing third-party, non-government organic certifiers.

Is FDA receptive to this idea? Not at this point. Well have to waitonce the comments have been submitted and strong lobbying has occurred,Harvey said. But this is the way to work with FDA, because the agencys notgoing 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 todescribe it so we can better evaluate their comments.