Contract Manufacturing

January 19, 2005

With the expected release of the Food and Drug Administration’s (FDA; Rockville, MD) good manufacturing practices (GMPs) for dietary supplements just months away, some companies are still struggling with the new regulations.

 

With the expected release of the Food and Drug Administration’s (FDA; Rockville, MD) good manufacturing practices (GMPs) for dietary supplements just months away, some companies are still struggling with the new regulations. Although many companies are able to manufacture GMP-compliant products on their own, others may benefit from contract manufacturers, which can offer expertise, efficiency, and experience.

Most companies are eagerly awaiting the publication of the final GMPs in the Federal Register. According to several contract manufacturers, interest in the new rules is high.

“Once the GMPs are published, every manufacturer-by choice or default-will have to adhere to the GMPs adopted by FDA,” says Suhail Ishaq, GMP Laboratories of America Inc.’s (Anaheim, CA) vice president. “Naturally, customers want to make sure that their manufacturer is in compliance with quality manufacturing standards.”

“More so than ever, our customers want to review our GMPs and complete HACCP plan to ensure that their products are produced to the standard level they expect,” adds Bill Schmitz, president of Main Street Ingredients (La Crosse, WI). “Our customers demand exacting standards and are very interested in the policies and procedures we have in place.”

ADVANCED PREPARATION

Although the GMPs have been in the pipeline for some time, contract manufacturers haven’t been sitting still. Many have already prepared for the GMPs by complying with other sets of stringent quality control requirements. How a contract manufacturer handles these other practices can say volumes about its approach to GMPs.

For instance, Ishaq notes that GMP Laboratories is accustomed to dealing with GMPs because it already holds a drug manufacturing license for over-the-counter (OTC) products. “We have long adopted OTC drug GMPs in anticipation of the forthcoming GMPs for the dietary supplement industry,” Ishaq says. “GMP Laboratories uses a six-volume, 200-page set of standard operating procedures that details each step in the manufacturing process.”

Similarly, NutraMed Inc. (Chino, CA) has also been using drug GMPs in the absence of final GMPs for dietary supplements. “We feel that we will be well prepared for the new regulations when they are published,” says Gary Callahan, NutraMed’s director of operations.

Other companies, such as Rhema Industries Inc. (Bellingham, WA), are complying with GMP requirements from other countries. Rhema, whose parent company is based in British Columbia, meets Canadian requirements for manufacturing drug products.

“As a North American company with manufacturing facilities located in Canada, we already operate according to the GMPs required by Health Canada,” says Lucy MacLoughlin, Rhema’s COO. “We anticipate that FDA’s GMPs for dietary supplements will be on a par with Canada’s regulations for natural health products, and less stringent than the GMPs that Rhema currently applies.”

To further bolster their GMP credentials, contract manufacturers may also opt to be audited by third-party sources, such as the National Nutritional Foods Association (NNFA; Newport Beach, CA), American Institute of Baking (AIB; Manhattan, KS), and the National Food Processors Association (NFPA; Washington, DC).

“Main Street is a USDA grade-A and kosher facility that is routinely audited by customers and third parties, like AIB and NFPA,” Schmitz says. “We pride ourselves on our high quality, and we are current on our GMPs, which is an important aspect of our complete HACCP plan.”

Likewise, GMP Laboratories is currently in the process of obtaining a GMP certificate from NNFA, Ishaq says.

WHAT TO LOOK FOR

Although there are many companies that offer contract services, not all are equal. There are several things that companies can look for to make sure that they choose a contract manufacturer that is likely to comply with the GMPs.

“A company looking for a contract manufacturer should choose a manufacturer that is experienced, qualified, dependable, responsive, and quality conscious,” says Ishaq.

And, while there are many things that companies need to look for, there is one thing companies must do when evaluating contract manufacturers.

“To choose a contract manufacturer, a company must, without fail, do an audit of the facility to ensure that the proper controls are in place to protect the quality of their product,” says Callahan. “This would include all quality systems, standard operating procedures, and an active training program for all employees that would ensure that all regulatory compliance is being upheld.”

LEVEL PLAYING FIELD

Perhaps the greatest impact the new GMPs will have on the industry is that they will make it difficult for subpar manufacturers to operate. Contract manufacturers expect the GMPs to have a positive effect on the industry by ensuring that only the most reputable companies stay in business.

“We believe the new GMPs will increase cost and drive out the smaller, unqualified companies engaged in the manufacturing of dietary supplements,” says Ishaq. “Companies that we call ‘garage-type’ operations will have a harder time staying in business.”

“In many cases, the new regulations will force certain companies to make the decision whether to be in this business or not,” agrees Callahan. “For years, there have been those companies that were only in the business to make a profit. Granted, that is what every business is for. However, there are plenty of less-regulated businesses to be involved in that don’t manufacture something that will eventually end up in someone’s body.”

Of course, the new GMPs will only be useful if they are properly implemented. Much depends on how FDA handles the new GMPs once they are published.

“If FDA invests adequate energy and resources into enforcement, it will help cull unscrupulous operators, strengthen the industry as a whole, and hopefully create a more level playing field,” says MacLoughlin.

If that happens, contract manufacturers expect an increase in demand for their services, as well as an increase in demand for quality products overall.

“Qualified companies should notice a pickup in business once the GMPs go into effect,” says Ishaq. “The newly established standards will also help increase the quality of product being consumed by the end-user. All in all, this will be a beneficial move for our industry.”