Efforts to standardize documentation practices detailed at UNPA meeting
The sessions were part of the Raw Materials & Supply Chain Summit put on by the United Natural Products Alliance recently in Salt Lake City. The meeting included sessions on DNA testing, on global supply chain issues, and new technology for tracking and tracing.
Questions about documentation and nomenclature are a complicating factor in this scenario. How ingredients are specified and what kind of forms that are used to do that are things that have grown organically, so to speak, as the industry itself has grown. Suppliers and their customers have done what makes sense to them for their own operations making it difficult to try to match apples to apples across the supply chain.
SIDI Work Group address supplier/manufacturer interaction
Two sessions at the meeting focused on the rationalization of these documentation procedures. Duffy McKay, senior vice president of scientific and regulatory affairs for the Council for Responsible Nutrition, updated attendees on what the SIDI Work Group has accomplished, and Casey Coy of NSF International provided insight into the developing work of the Global Retailers and Manufactures Alliance, a group that she manages.
SIDI stands for Standardized Information on Dietary Ingredients. MacKay said the effort was a coalition of trade groups including the Consumer Healthcare Products Association and the United Natural Products Alliance along with CRN. The American Herbal Products Association participated as an observer. The goal, MacKay said, was to standardize how manufacturers asked for and recorded information about their incoming raw materials, including standard protocols for a Dietary Ingredient Information Sheet, certificates of analysis and supplier qualification. It was an attempt to fill in the obvious gap created when dietary supplement GMPs came online in a form that omitted ingredient suppliers and put all of the responsibility for making sure incoming raw materials are GMP compliant onto the manufacturers’ shoulders.
“This represents 10 years of collaboration,” MacKay told the attendees. “We know that the GMPs are not prescriptive in mandating supply chain requirements. Historically we know that the dietary supplement industry has lacked clarity in applying supply chain management principles.”
The hope is that the SIDI principles could aid industry in its self regulation efforts, MacKay said. Additionally, if more regulation is either called for or becomes unavoidable, the protocols developed by the group could form a reasonable basis for any new laws, he said.
“This can form the basis for a quality practice. It’s not just a bunch of check boxes. Self-regulation is always preferred and we don’t want a bunch of new regulations that are not fit for purpose for our industry,” MacKay said.
The standardized protocols can make supply chain management much easier, MacKay said. Change control is simplified, and on the suppliers’ end, compliance is made easier. Back in the day and still to a large degree, each manufacturer has its own set of requirements for information from suppliers. Even though the SIDI documentation guides are freely available, not everyone seemed interested in using them, though that has started to change, MacKay said.
“The initial adoption was slow. Then the New York Attorney General came along and everyone started to say they needed standards. We have learned that FDA inspectors have become familiar with the SIDI format, and they are pleased when they see documentation in that form when they are inspecting a facility,” MacKay said.
GRMA effort for retail/manufacturer interface
Casey Coy gave attendees a look at what progress the group she manages has made to develop standards for one step further along the supply chain in an effort to standardize what information retailers are looking for from manufacturers and how they ask for that information. The effort seeks to standardize information gathering for OTC drugs, medical devices, dietary supplements and cosmetics and personal care products. The effort has participation from many stakeholders with the dietary supplement industry including FDA, CRN and UNPA. Major manufacturers and retailers that are cooperating include NBTY, Perrigo, Target, Walmart and Whole Foods.
Coy said the goal is to develop one standard and one auditing scheme that would apply to each of the four industries. The new standard will improve safety, provide better risk management and streamline the interactions of retailers and manufacturers, she said. The stated goal for the dietary supplement portion of the effort is to have a draft standard completed by the middle of 2016, though Coy said that might be seen as more of an aspiration rather than a realistic goal.
“It’s a known fact within NSF that standards development can take 18 to 36 months. Ideally we’d like to have a draft standard by the end of the year. We’re not reinventing the wheel. We are just creating a better platform for compliance with existing regulations,” she said.