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Validated Analytical Methods:
The Case for Quality Measurements
January 6, 2005
5 Min Read
Validated Analytical Methods:
The Case for Quality Measurements
byAOAC International
The abilityto address many questions relating to the safety and efficacy of dietarysupplements is critically dependent upon the existence of high-quality,reliable, validated analytical methods. Similarly, any attempt to level theeconomic playing field between the majority of reputable manufacturers and thefew fly by night producers of inferior or mislabeled products will alsodepend on valid and defensible measurement techniques. These needs run the gamutfrom measurements of identity, dosage and impurities to the invitro or in vivoanalyses required in clinical trials. TheOfficial Methods of AnalysisSM endorsed by AOAC International are unique due to the stringentvalidation requirements and collaborative studies required for an analyticalprocedure to gain the status of an AOAC Official MethodSM. These high AOAC standards have earned AOAC methods officialrecognition by regulatory agencies throughout the world and are specificallycited in the U.S. Code of Federal Regulations.
The current Good Manufacturing Practices (cGMP) are a resultof U.S. agencies efforts to regulate the safety, efficacy andadvertising claims made concerning pharmaceutical dosage forms throughout thesupply chain. The Good Laboratory Practices (GLP) were the result of falsifiedanimal safety data submitted to regulators upon which decisions were madeconcerning the safety of pharmaceuticals, pesticides and industrial chemicals.The Good Clinical Practices (GCP) were an agency response to questionable safetydata coming from clinical studies, upon which decisions are made as to broadsafety and marketability of a product.
Dietary supplements have recently been the focus of attentionfrom regulatory agencies and the general public in large part due to problemsencountered with ephedra.These problems gained the attention of national mediaand generated large amounts of publicity. Is it any wonder, then, that thedietary supplements industry has come under a regulatory microscope? Labelclaims are certainly a predominant issue. The availability of certifiedreference materials and validated analytical methods and the consistentapplication of scientific evidence are needs that, while being addressed,require support so that a leveling of the playing field can be accomplished withminimal disruption to profitability.The overriding need of the regulatorycommunity at this time is reliable consistent methods that accurately andprecisely measure content and uniformity.
The U.S. Food and Drug Administration (FDA) and the NationalInstitutes of Health (NIH), Office of Dietary Supplements (ODS), in 2003co-sponsored the development of these methods through a contract with AOACInternational. Although generous, the contract is limited when one considers thecomplexities and magnitude of expert volunteer assistance required to accomplishthis monumental task.Why should the dietary supplements industry activelyparticipate in this process?
Quality Improvement: Quality monitoring withvalidated analytical methods will result in less down time, less rework andfewer recalls. Organizations that actively monitor quality find that qualityimproves as a result of the monitoring.
Supply Chain Improvement: Are your suppliersreliable? Are new supply sources adequate? Are your low-cost suppliers providingminimum quality materials?
Regulatory Success: Efficient compliance withcGMP, ISO 9000, etc. will result in less regulatory scrutiny and betterreputation.
Market Control: Knowledge that the playingfield is level as well as developing data to support that products are up tocompetitive and regulatory standards.
Publicity Control: When problems arise, theavailability of validated test methodology allows companies to evaluatepotentially damaging information quickly and thus facilitate problem resolution.Product claims can be validated, and damage to brands and goodwill can beavoided from bad publicity.
Liability Control: Use of reliable testmethodology helps avoid regulatory problems such as cGMP violations, shutdownsand recalls. They can provide indispensable help in defending against civilclaims of unfair competition or lack of due diligence. They can even sometimesavoid criminal problems, where failure to use valid analyses can be construed aswillful and knowing misconduct.
Goodwill/Intangibles: Participation ontechnical committees provides a networking opportunity for new technical andmarketing personnel, and develops a companys reputation as a result of suchparticipation. It also assures that companies are kept current with theanalytical methods necessary to control their products.
Research and Development: Development and useof validated methodology in the research and development process providesconfidence that a products label claims are achieved by avoiding analyticalpitfalls.
Laboratory Efficiency: Sharing the efforts andresources necessary to develop collaboratively tested methods that have theruggedness to avoid test failures and re-analyses commonly associated withunvalidated procedures results in significant overall cost savings.Validatedtest methods allow for suitability assessment of the procedure for specificanalytical needs.
Clinical Studies: Assurance that products usedfor clinical studies are properly characterized and meet accepted standards. Reliable analytical methods produce accurate data, which inturn permit valid clinical conclusions to be drawn.
Although not specifically stated in the above list, the costis considerable in time, resources and money. However, the alternative of eachindividual business substantiating the validity of its methods and referencestandards to an agency investigator would far exceed an earlier, jointinvestment.
Broad industry representation and participation in thisprocess would benefit all parties, ultimately providing official AOAC defensiblemethods that are validated to the fitness for use criteria of providing thesafety and assurance of dietary supplements offered to the public. It can berewarding and cost-efficient to work together as partners toward resolution ofindustry and regulatory issues in a collaborative and scientifically soundmanner.
AOAC therefore urges companies to support this joint FDA/NIHventure to provide the dietary supplement industry with legitimate analyticalmethods for commerce. Consider volunteering some of the time and laboratoryresources of a company analytical chemist to share expertise in this endeavor.
AOAC acknowledges the authors that contributed to thisarticle: James Ault, Ricerca; Edward Waysek, Caravan Products; Rick Myers,Weider Nutritionals; James Roza, NOW® Foods; Dana Krueger, Krueger Foods; JamesNeal-Kababick, Flora Research Laboratories; and Aniko Solyom, University ofArizona. For more information or to get involved, contact James Roza, chairmanof the AOAC Task Group on Dietary Supplements, (630) 545-9098, ext. 120,[email protected]; or Anita Mishra, AOACs principal scientific liaison,government and industry, (301) 924-7077, ext. 131, [email protected].
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