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Editorial: Opening That Testing 'Black Box'

By Len Monheit, NPIcenter

At a series of seminars covering 'Certificates of Analysis' and 'Contract Analytical Labs' in Salt Lake City last week, I was struck immediately by the observation that the seminars I was attending could not have been pulled off a few years ago and so were yet another sign of this industry's evolution and maturation.

The fact that so many people in the room were prepared to invest in and attend a session so highly technical (in fact the discussions were frequently as practical as they were technical) meant either that pre-GMP panic is starting to manifest itself, or that enough players in the industry have begun identifying and targeting the supply chain's weak links and vulnerable points - quality, source control and certain contract services.

The term 'garbage in, garbage out' was used a few times over the two day symposium, which was hosted and organized by the Utah Natural Products Alliance (UNPA). Ingredient sourcing, evaluation of supplier certificates of analysis, testing of incoming raw materials as well as contract lab selection and performance were the subject of animated discussion among the 65-plus attendees plus speakers and presenters.

From the event, discussions and dialogue, several other observations struck me. First of all, the fact that only four ingredient companies attended might have meant several things. Possibly, they didn't hear about the event or had conflicting obligations (let's give them the benefit of the doubt), Perhaps they didn't understand the context of the presentations. Quite possibly, since the wording of FDA's proposed GMP rule from a few years ago indicated that the onus of responsibility for testing would be on manufacturers rather than ingredient suppliers, the role of the ingredient supplier in a tightening supply chain was obscure at best, and they decided to skip this presentation. If this session is any indication on where a good portion of the responsibility should lie, ingredient suppliers and those involved with sourcing and supplier evaluation will operate at the most critical juncture and interface in the supply chain, over the next few years.

The mystique surrounding lab capabilities and analysis was explored in several presentations. It was generally agreed that more critical lab evaluation, stronger manufacturer / lab relationships and higher general expectations would be the rule of the not too distant future.

There were about a dozen groups in the audience either directly providing contract analytical services or responsible for quality assessment programs or services which involved product testing, so it was possible to get a decent picture of the analytical capabilities landscape in both the United States and Canada. Since AOAC and the research community were both represented, it was possible for attendees to readily observe the connection between such apparently removed subjects as method development and validation and the provision of sufficiently high quality products for clinical trials and general research.

The finished product manufacturing community was well represented with a cross-section of small to large companies. Without a doubt, attendees emerged with a consensus that they needed both a better understanding of the details presented and inherent (or assumed) in a supplier provided Certificate of Analysis (C of A) and that a more critical examination of frequently deficient Certificates of Analysis needed to become standard company practice. In the same way, contract lab services needed to be better understood and qualified, frequently with a much higher set of expectations for the contractors performing these mission critical services.

According to several sources, FDA is expected to issue the final GMP rule as soon as September. Smart companies have been shoring up quality practices and procedures for years, including a heightened focus on source control and lab operations (contract and in-house). Last week's seminars indicated quite clearly that some organizations are quite prepared, others are panicking, many ingredient companies just don't get it, and that many companies just don't know what questions to ask (or of whom) as they seek to improve quality practices.

One of the outcomes of last week's event is dialogue on the creation of some C of A templates that can help raise expectations and plug holes and deficiencies commonly found in current C of A's. Another outcome is the continuation of dialogue between those developing and evaluating methods and those employing them in certification or quality assessment programs. (NSF, USP,, AOAC).

An additional outcome is a raising of the baseline level of education involving both the specifics and implications of C of A and analytical terminology. Companies need to know how to read a C of A and analytical documentation and identify deficiencies in both. Many currently do not. Ingredient suppliers and labs can and have been taking advantage of this ignorance to the detriment of their clients as well as consumers. Follow up will obviously need to include further education involving lists of terms and higher expectations of those providing these services, raw materials and documentation. On the flip side, presumably, purchasing behavior that is solely price-based must be eliminated and longer term relationships must be invested in and supported.

Finally, it is becoming quite clear to those that 'get it' that some of industry's black boxes must be opened or removed. Practices such as 'test 'til it passes', 'bait and switch' with pre-selected raw materials, and 'hot potato supply chains' are not conducive to long-term success, and those directly employing these practices, and those that use suppliers and contractors using these techniques (ingredient suppliers and contract labs) will not be around long-term.

With education and more transparency, we, as an industry, can rid ourselves of these companies and practices in a shorter time frame. By placing higher expectations on supplier Certificates of Analysis and asking better questions, we show we value those that comply with these expectations already. By working and partnering with analytical labs who go that extra step with method identification and validation, we not only ensure product reproducibility and quality, we invest in a relationship that allows the integration and enforcement of GMP's.

For those on the leading edge, perhaps teaching your clients the right questions to ask might lead to them valuing your capabilities more.

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