PCQI – A Newest Ingredient for Compliance

December 12, 2017

Phew, that was intense, and now it’s over and I’m rather glad. It was worth it, though.

Last week I successfully completed the Food Safety Preventive Controls Alliance (FSPCA) course titled Preventive Controls for Human Food, meeting the requirements of the regulation (21 CFR Part 117.180(c)(1)) as a Preventive Controls Qualified Individual (PCQI). This training was offered by the United Natural Products Alliance (UNPA), in Salt Lake City in early December.

Yes, PCQI and FSPCA are a lot of letters, but I am now certified, as were the other twenty-nine folks, who completed the two-and-a-half day, twenty-hour curriculum that dug deep into the newest regulations under the Food Safety Modernization Act (FSMA) and its specific impact for the dietary supplement industry. And there will be significant impact, although it may be some time before the totality of this impact filters through our hugely convoluted supply chains. Many in our industry are still unaware that the Food Safety Preventive Controls piece of FSMA augments the supplement industry GMPs (21 CFR Part 111) and while supplement companies may have fewer incremental requirements under 21 CFR 117 specifically, there ARE requirements, many of which directly impact their supply chain and supply chain responsibilities. And for those supplement companies increasingly making food format products with traditional food-type supply chains, their thinking and understanding will need to evolve.

It was apparent that the course today, as currently written, gave inadequate thought to the realities of today’s dietary supplement industry. With the potential amount of toll and outsourced steps, and with a complicated field to market product aggregation pathway (including potentially multiple distributors), the course models were simple. For purposes of the training, they provided excellent examples of the evaluation and development stages for the Food Safety Plan that then need to be augmented and pushed back into the true supplement supply chain. Discounting the course on that basis (current model relevancy) would be truly unfortunate.

Plus, should FDA take its intended risk-based priority approach, with the dietary supplement safety record being quite solid, it could be some time before laggards in our industry feel the acute need to address their obligations under FSMA (much of the industry does have a bit of a rap for doing things only when absolutely forced) – also unfortunate. In this case, that would also be a huge missed opportunity, since the proper implementation of a preventive controls system finally allows top-tier supplement companies to shine a light on what have traditionally been opaque supply chains, in addition to actually preventing a food safety control-related issue.

Several of those within the core supplements industry can be described as early adopters, and with the focus and attention that UNPA is putting on this and other FSMA training programs, many UNPA member companies (ingredient and brand) are starting the training and PCQI certification process. During the course, we were told of one dietary supplement company official, who was asked on the organization’s regularly scheduled audit date by FDA about his PCQI status. Apparently, regulate and educate is truly the order of the day, as his answer, “My course is next week” was a satisfactory answer – for now. It’s only a matter of time before things get tougher, expectations get higher, and the irony of this regulation is that if implemented properly, it’s a huge chance for ingredient companies to differentiate themselves and add value to their clients’ risk management strategies.

Back to the course itself. It has been well-designed, but as noted, from a food focus, all the way from field/aggregator to finished goods. While the PCQI instructors were well able to tell and incorporate real life stories and utilize a supplement model during the training, several of the training modules are too easily dismissed as ‘food only’. This course will be further adopted and taught to be supplement specific. We also, as PCQI instructor Larisa Pavlick from UNPA stated, “have the chance right now to write and influence the supplement industry guidance document that will dictate how FDA inspectors treat the sector”.  That’s a huge opportunity that as many as possible should get on board with by engaging with the course, the regulation and the process.

This regulation affects everyone’s manufacturing controls (mostly covered by GMPs) and additionally, supply chain and Preventive Controls analysis of it. In addition to the basic safety premise, this now impacts thinking that will be involved at the time of supplier evaluation, change of source, vendor audits and requirements, and in some cases, examination of process technology much further upstream than ever before.

Related to this is FDA’s recently introduced Foreign Supplier Verification Programs (FSVP), which: “requires FSVP importers to verify that the food they import meets U.S. safety standards. FSVP importers are required to develop, maintain, and follow an FSVP for each food imported, unless an exemption applies. The goal is to ensure that each food is produced in a manner that provides the same level of public health protection as the preventive controls and produce safety regulations, if applicable, and the food is not adulterated or misbranded with respect to allergen labeling”. UNPA is among industry groups that will offer this training in 2018 and beyond.

Globally, those seeking to do business in the United States are impacted. The relatively free pass on ingredient companies originally offered in the dietary supplement GMPs has now been removed. There are additional risk measures (and obligations) faced by companies offering food format products, and there are now several new elements added to the product sourcing equation including ensuring the ability of the ‘supplier’ to support the new obligations under 21 CFR 117.

For some, it’s prudent risk management. For others, this change in roles, needs and expectations represents opportunity.


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Lori Diez combines compassion and excellence to lead organizations to their next level. A small-town Texas childhood taught her the value of hard work and relationships, which she uses to foster teamwork that brings results that have transformed cultures and programs to their highest potential. Her successful career in pharmaceutical and nutraceutical sales leadership and event hosting has prepared her to deliver results as the COO of TrustTransparency, where she uses her industry knowledge to ensure that the company’s operations run smoothly as they support nutraceutical companies in their mission to help others. Lori’s passion for charity reflects her belief that individuals working together can change the world, no matter how small their contribution to the effort. This year, she looks forward to continuing over a decade of service at the Houston Livestock Show And Rodeo, where she will be the Chairman of the Livestock Committee.

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