By Len Monheit
Last week, AOAC and UNPA (Utah Natural Products Alliance) teamed up to present a day-long symposium on analytical methods. The subject has many implications.
In the United States, as the supplement industry anticipates GMP's, analytical methods and the degree of testing requirements placed into the rule will have an impact on product and operational costs. Gaps or inadequacy in either quantitative or qualitative testing has been blamed on absence of appropriate methods, and simply monitoring the news including events such as the AOAC/UNPA one this past week indicates that there seems to be some streamlining and coalescing of method development efforts. It's certainly about time, and yes we need to certainly understand analytical challenges particularly in the products we're bringing to market - whether this is the complexity of multiple molecules with no clear single active, complex matrices with inadequate extraction methods, or finished products in soft-gels or other forms (even foods) where it is challenging to say the least to quantitatively measure many components which may even interfere with each other.
The Salt Lake session last week covered topics ranging from 'Why (validated) analytical methods are key' to 'the challenges of botanicals', the CRN omega-3 working group that has so significantly raised the quality bar for omega-3 products, and 'In-house Versus Official Methods'. It raised issues such as lab accreditation, in-house versus outsourced analytical work, and introduced the subject of vendor certification and qualification programs, all subjects we can expect to hear a lot more of.
Unfortunately, other commitments made it impossible for me to attend this event. So I’ve had to operate, in this case, at second hand to understand the implications of what was presented. Based on the presentation materials, there are a few key points that have really got my attention.
First of all, the omega-3 working group at CRN continues to be an excellent proactive model where industry collaborated and set out to drive standards, and raise quality and promote a category as part of a broad objective. (I applaud those companies for seeing a big picture and putting competition aside (understanding legal obligations all the while) and built a bigger tastier pie.
Secondly, I am now aware of the new AOAC policy (March) regarding matrix extensions, which seems to indicate recognition of the need to dramatically speed up the method development, validation and acceptance process and which allows a:
"quantitative chemistry method is extended to a new matrix and the method is not changed, an SLV is sufficient if done according to AOAC approved guidelines, and approved by AOAC methods reviewers.”
Third, Paula Brown of the British Columbia Institute of Technology, as she spoke about recent Canadian experiences in comparing lab proficiency, raised the issue of lab standardization and possible establishment of proficiency guidelines including certification, or in fact, accreditation. She noted significant differences in lab performance, some of whom were just not up to the task of analyzing natural health products.
Finally, the presentation on vendor certification and qualification, presented by Glen Putnam from USANA Health Sciences, asked the question 'Who in your organization will handle the relationship with the supplier?' An additional question occurs to me, 'if a company chooses to outsource analytical functions, what level of internal resources and skills are required to adequately manage these relationships?'
Both these questions are significant. Obviously inadequate expectations or not asking the right questions could have disastrous results - in each case. In some of the larger companies, one would expect more infrastructure and hence more developed sourcing procedures, qualifications and resources. These organizations would also, presumably, be more likely to have relatively complete in-house lab facilities. Smaller or mid-size organizations would be facing the biggest conundrum. The very reason they have decided to outsource lab services is the reason they are lean on internal lab resources. Can they adequately manage an external lab relationship? And as far as sourcing is concerned, the same generalization might apply, that is, because they are so lean, they're understaffed in QC/QA to begin with and having effective in-house oversight of sourcing and vendor relationships (above and beyond buying and inventory management) can be resource intensive.
This last point is a perfect segue into the next planned activities by UNPA - a two day workshop June 16-17, where Day one will be "Certificates of Analysis for Dietary Supplements" and Day two will be "Finding, Auditing and Managing Contract Analytical Labs for Dietary Supplements."
As a past life manager of a contract analytical lab, I've got a keen interest in these presentations. I'm glad to see this type of dialogue becoming ongoing and active, and away from the major trade events. As the presentations at the recent seminar indicate, these issues traverse national boundaries and different regulatory schemes and speak towards developing an international infrastructure of analytical standards and quality expectations.