Good Manufacturing Practices

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Overriding the entire issue of authenticity, purity, and quality are the GMPs mandated by law to be used in the manufacture of botanical dietary supplements. The FDA has the primary regulatory jurisdiction over the manufacture of botanical supplements and botanical drugs. For botanical supplements, manufacturers are required to develop standards of identity, purity, strength, and composition and to manufacture the product in a manner that will prevent adulteration. Botanical drugs are subjected to the same GMPs applied to conventional pharmaceuticals.

A primary focus of the current GMPs is to ensure authenticity of the raw material used. Every manufacturer is required to perform a minimum of one "scientifically valid" test to ensure the identity of the botanical. This means that manufacturers cannot rely upon paper documentation from a supplier, as was the practice in the past. Moreover, it is critical for the test to have a great enough degree of specificity to make such a determination with confidence.

It is in the process of identification that the botanical assessment skills of the classic pharmacognosist are so important. Very seldom can identification and assurance of the absence of an impurity or adulterant be determined chemically or with any other more sophisticated test. For example, as was noted previously regarding goldenseal, other berberine-containing plants or goldenseal leaf may be mixed with root, thus giving the expected chemical profile. Alternatively, the appropriate part may include a percentage of dirt due to improper cleaning; this will go undetected in a typical chemical analysis, but is readily discernable through macroscopic or microscopic evaluations through visual observation and color reactions (Table 3.3).

Thus, the botanical evaluation skills of the classic botanist, herbalist, or pharmacognosist are critical to GMP compliance. In establishing specifications for composition, strength, and contaminants, it is best to follow some independent standards, such as those established in national or international pharmacopoeias.

Quality means that the dietary supplement consistently meets the established specifications for identity, purity, strength and composition and limits on contaminants and has been manufactured, packaged, labeled and held under conditions to prevent adulteration... (Title 21 of the Code of Federal Regulations)

Table 3.3 Examples of Sand, Starch, and Fillers and Their Chemical Reactions

Adulterant

Mountant/Treatment

Characteristics Observed

Image

Sand

Chloral hydrate

Rainbow colors with polarized light

100.00 um

Starch

Glycerin

Maltese cross with polarization

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