Recently, while assisting a company struggling to source consistently high quality ingredients from abroad, I came across an article in the March 2011 issue of Pharmafocus entitled “Sourcing Quality from Abroad” by Gary Leong of Canada’s Jamieson Laboratories. The article began: “As globalization of our industry continues to evolve…” which made me think it was somewhat out of date, because in my mind the natural products industry has been global for decades. However, as I read on, I realized that the evolutionary process continues, just as the discussion of quality continues to evolve. Mr. Leong noted that not only are more and more sources of raw materials coming on line, but that technologies that also permit the proliferation of sources continues to evolve as rapidly as technology itself. 
 

Decades-old fermentation and synthetic processes are giving way to new techniques for production of rare and costly ingredients that simultaneously increase supply and lower price. This evolution can be a boon or a bane. The boon is in ingredient cost and availability. However the rapid introduction of suddenly available, seemingly familiar ingredients into the global supply chain can also be a bane. Why might that be a bane? For natural product ingredients the process makes the product and the product of a new process rushed to market might carry baggage from the process itself into the marketplace (think L-tryptophan/EMS). In addition to the “old” quality questions associated with natural products—e.g., authenticity, economically motivated adulteration, heavy metals, pesticides, mycotoxin, and microbial contamination—comes a new layer of complexity, and unintended consequences. 
 

As I read on, I decided this would make an interesting Nutraceuticals World column, so I contacted the author himself to request he join as co-author of this month’s “Quality Focus” column. In Mr. Leong’s words (and with his permission), “Tapping into global suppliers can either be an opportunity for improvement or a source of recurring nightmares for manufacturing companies. The key factors which determine the outcome are timing, vigilance, communication and proper quality management.” 
 

The challenge for manufacturers is to manage a supply chain change if it arises. Changes in suppliers may mean changes in processes, changes in specifications, and changes in reasonably anticipated contaminants. When all materials in the marketplace were more or less the product of a single production process, specifications could be, and often were, relatively similar across manufacturers. In the modern supply chain, having a highly developed and well-justified set of specifications is mandatory. When re-sourcing of a raw material is the best option, excellent communication and proper management are vital. Communication of the manufacturer’s needs (in the form of specifications, etc.) to the prospective supplier and communication of the supplier’s capabilities and processes to the manufacturer set the stage for a negotiated supply chain with realistic expectations by both parties. 

According to Mr. Leong, Jamieson uses a four-phase qualification process (see Figure 1, page 40). The first phase involves a thorough paper evaluation of the new material and its supplier. The Quality department performs a detailed paper review of the specifications of the candidate material for conformity to the quality and purity standards detailed in Jamieson’s own specifications. If the paper review is acceptable, the review continues to the next step, but only if it meets some specific corporate requirements concerning natural sourcing, allergen potential, sustainability, traceability and animal-free testing. 

While this is going on, another paper review, this time using a quality questionnaire, is performed on the production facility. The SIDI (Standardized Information on Dietary Ingredients) Work Group—a coalition of the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN) and the United Natural Products Alliance (UNPA)—have developed guidelines as tools to assist dietary supplement manufacturers and ingredient or component suppliers with the process of supplier qualification. These guidelines can be found at http://sidiworkgroup.com and include the SIDI Protocol, previously introduced in a “Quality Focus” column (Nutaceuticals World, November 2009), which outlines in a standardized format the type and scope of information an ingredient supplier may need to provide to a manufacturer as a helpful starting point in the documentation aspects of ingredient supplier qualification.

If the material and facility pass first-stage scrutiny, multi-lot samples (typically from 3-5 lots or batches) are acquired and evaluated in-house. Each lot is tested in the laboratory and results are compared to established specifications. Each lot is also evaluated for “fit for use” consistency. This inspection includes elements such as color, flow characteristics, particle size, bulk density and particle morphology. The idea is to source a consistent material that can pass right from the receiving dock into the process stream (following release from quarantine after it passes the incoming raw material tests, of course) without having to worry whether each batch of finished product will look, taste or smell different to the consumer. The key evaluation criterion is consistency of quality.
 

If the material successfully passes the first two phases of evaluation, then the review continues and auditors are sent to inspect the manufacturing facility against a suitable standard. Mr. Leong cited FDA’s Guidance for Active Pharmaceutical Ingredients in his Pharmafocus article as one example. Of all the evaluation steps, the quality audit is the most critical part of the qualification process, especially for overseas suppliers. In addition to providing concrete evidence of ability and capability, the quality audit provides visual proof of the suppliers’ compliance with in-country and overseas regulatory requirements and provides the perfect platform for in-person communication of values and expectations for both parties.
 

In the past, when there were fewer suppliers and fewer manufacturers (and fewer regulatory regimes), it was possible for key personnel to know all the players, if not personally, then by reputation. In that environment, managing expectations was relatively simple. Expectations were largely implied through a shared context stemming from a common history, environment and understanding of the regulatory paradigm. Shared context meant that values and expectations could be generally understood. Companies could also rely, in part, on having an established business reputation as a means of implicitly communicating their corporate standards. 
 

Globalism and global supply chains have eliminated much of the context based on shared laws and marketplace knowledge, and overseas suppliers often know little of their customers and the environment in which they do business. The audit thus serves as an opportunity for auditors to help suppliers learn more about the manufacturer than what can be conveyed by a spec sheet, and wise companies expect auditors to be educators as well as information gatherers. Manufacturer expectations that are left unstated or ambiguous will be interpreted within the context of common practices and norms that are prevalent in the domestic environment of the supplier. Assuring that all requirements and their underlying purposes are understood are key duties of the audit team.
 

Efficiency, economy and innovation are goals common to most nations, but the processes by which such goals are achieved may be more important in some countries than others. If a company values transparency, written protocols, extensive documentation, state of the art quality assurance methodology, and a systematic and documented approach to process change, then those needs must be communicated to potential partners early on. Ensuring that expectations and values are fully understood and will be met does not end upon the completion of a successful audit. Offshore manufacturing sites often require more follow up and monitoring than do domestic sites. This includes more diligence toward ensuring audit findings are properly addressed. Multiple site visits will probably be needed before the site becomes fully aligned with expectations and is finally accepted as a qualified supplier.
 

If the first three phases of the qualification process are performed properly, the fourth and final phase of routine monitoring should yield no surprises. The monitoring program, which includes ongoing quality control testing, serves as added assurance that expectations and values were properly communicated, understood and are being implemented by the new supplier. 
 

The global shift of the supply chain for critical raw materials presents companies with many opportunities and challenges. Managing the shift is essential for continued success of manufacturing companies. A robust quality system that takes into account the assessment of the quality of the potential material and its manufacturer as well as the establishment of clear standards and expectations creates the foundation on which successful overseas partnerships may be built. If performed properly, sourcing from abroad can be an effective way to optimize costs and introduce innovation.

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