Seeking Clarity in Specifications

by Gabriel I. Giancaspro, Ph.D.

The dietary supplement industry is grappling with implementation of the federal cGMPs (current good manufacturing practices), which are now in full effect for manufacturers of all sizes. A key area of emphasis is written specifications for incoming raw materials, in-process materials and outgoing finished products. These specifications are an essential requirement of the cGMPs; yet, their widespread absence has proven to be among the most common problems FDA inspectors are finding as they scale up enforcement activities. Written specifications are fundamental components of ensuring the quality of a product or ingredientdefining, at its core, the products identity. In fact, the cGMPs pay special attention to identity, requiring 100-percent testing for this parameter. However, essential specifications are not set only for identity, but also for composition, strength, purity/contaminants, performance, packaging requirements and storage requirements. Specifications include acceptance criteria for a test, but these are only as good as the associated analytical procedure for that test. These analytical procedures should be scientifically sound, according to the cGMPs. Multiple tests are often necessary, as a single test may not yield all the necessary information to fully characterize a parameter such as identity, purity, contaminants or content. Thus, specifications are defined by one or multiple tests, with their accompanying analytical procedures and acceptance criteria in numerical ranges or qualitative characteristics (e.g., matching fingerprint, presence or absence of botanical characteristics). Without these three elements, manufacturers cannot characterize what they are incorporating into their finished productsor if the finished products are what they expect, and claim, them to be. Also, the quality of the finished product bought by consumers who rely on the dietary supplement is equally uncertain.

Developing specifications for dietary supplements and dietary ingredients is especially difficult given that sourcing often occurs from complex living materials, e.g., plants. Less problematic are single, well-defined and purified molecules, such as vitamins or amino acids, and other simple substances, such as glucosamine. Setting specifications for complex mixtures such as extracts from plant materials is more challenging.

While companies can and do write their own specifications, public standards offer advantageswhether taken as provided, or used as a resource for writing proprietary specifications.

Public standards help harmonize specifications across a diverse industry. This assists manufacturers by providing a common set of criteria against which to compare suppliers. Comparing suppliers is often an ongoing challenge, particularly as price pressures dominate, sourcing is global and more complex, and suppliers offer less-expensive substances. These materials may be legitimate, or they may not, and manufacturers need a mechanism for assessing the validity of the claims associated with the materials. A broadly accepted, mutually agreed-upon standard allows all partiesfrom supplier to manufacturer to regulator to consumerto have a greater level of confidence about the quality of the end product. In todays global manufacturing environment, having this common quality standard is critical to meeting the expectations of all.

Public standards with tests, analytical procedures and acceptance criteria for articles traditionally or formerly used for medicinal purposes are available from a variety of pharmacopeias, such as the European Pharmacopoeia, Chinese Pharmacopoeia and the U.S. PharmacopeiaNational Formulary (USPNF). For articles used in foods, specifications can be found in other compendia such as the Food Chemicals Codex (FCC), Codex Alimentarius, Joint FAO/WHO Committee on Food Additives (JECFA) and other authorized sources. Validated analytical procedures to be used in connection with suitable acceptance criteria can be also obtained from AOAC International. Standards with these specifications date back to 1820 in USPs case; for example, ginger was included in the first USPNF. Of course, these standards have evolved over time to reflect modern scientific approaches such as fingerprints from spectroscopic or chromatographic procedures as opposed to traditional color tests, for instance. From a simple definition in 1820 to the current standard that includes information on contaminants, pesticides and HPLC analysis, the ginger standard of today would be unrecognizable in 1820.

In the end, suitable, science-based specifications are both a business and a public health necessity. Industry is responsible for protecting consumers from harmful products, and due diligence through appropriate specificationswhether public or privateis a non-negotiable element.

Editor's note: For an in-depth look at the subject of specifications, Dr. Giancaspro will present a seminar entitled, "Writing Specfications for Dieary Ingredients and Dietary Supplements using Public Standards," on Tues. Oct. 11, from 4 to 4:50 pm, at SupplySide West trade show in Las Vegas. Click here for more details .

Gabriel I. Giancaspro, Ph.D., is the director, Dietary Supplements, for the U.S. Pharmacopeial Convention .