Supplement manufacturing is a $20 billion industry in the United States. This industry is a growing lucrative prospect. Because the cost of setting up a manufacturing unit is expensive, many clients prefer to use the expert services of a supplement manufacturer. However, before jumping on to the bandwagon, consider the challenges that might be encountered from a supplement manufacturer.Supplement manufacturers and their clients need to work closely together in the production of health supplements that are viable in today’s market, reflecting the needs of the community and most importantly-a quality nutrient that is consistently dependable and reliable. Hence, one of the most challenging areas is a manufacturer who gives utmost priority to quality control.
Poor Quality Control
Dissolution failure, sub-potency, super-potency, mis-labeling and a number of other problems continue to plague nutraceutical companies.Unlike synthesized products, quality control poses unique challenges for a natural product. Often, without extensive method development and research, it is not possible to verify the marker compound levels against the label claim (i.e. Supplement Facts Label). This is especially true when the compounds found in two or more of the botanicals are in the same class. When a product contains a blend of 10 botanicals that are not standardized extracts it is even more difficult.
Also, many botanical constituents will bind to excipients to some degree, making complete extraction difficult. And, once extracted from the botanical, many constituents will begin to degrade rapidly making verification difficult, if not impossible.Clients who have developed dietary supplement formulas should consider establishing a relationship with an independent laboratory that has experience in analytical method development and validation for natural products. By supplying the lab with a sample of each raw ingredient used in manufacturing, the lab can create controlled mock-ups of the formulation and compare them to the finished dosage product. In addition, the lab can test quietum plus each single ingredient to see how it compares to the original supplier’s C of A. Contract labs offer independent verification of the product’s quality. This has become increasingly important in today’s industry.
Another aspect to quality control is batch lot testing which ensures quality control at the initial level. The potency and purity of herbs depends on the quality of the raw herb used and the care taken in manufacturing. The NNFA GMP program mandates that all botanical raw materials be batch lot tested for identity every time. They require this as well as a number of other protocols because of the known lot-to-lot variations that occur in agricultural products.In order to save costs on an independent laboratory analysis of the finished product, supplement manufacturers may ask their client to depend solely on their production records to demonstrate that a particular production run was properly prepared.
Their records combined with analytical testing of the incoming raw materials, may suffice to meet the needs of their clients. But trends are changing. Quality Control has become extremely important.If there are no quality control measures established and a consumer survey reveals that the label potency claims do not match actual potency of the product, consumer confidence is lost. To avoid this situation, it is important for clients to establish quality control methods early and request for analytical reports from third party labs that prove that their products are meeting label claims before they accept shipment from the supplement manufacturer.
Non-Compliance to GMP standards
Numerous companies each year have products recalled due to a lack of GMP protocols in their facility. Poor-quality products are a problem. Consequently, people will not continue to buy ineffective products. The health supplement industry has begun to call for Good Manufacturing Practices (GMPs) on a voluntary and self-enforced basis. Make sure your supplement manufacturer is GMP compliant and adhering to its policies. Although the FDA has yet to finalize the dietary supplement industry GMPs which were mandated in the 1994 DSHEA act, pharmaceutical GMPs have been in place for some time.
Inexperienced Research and Development Department
The R&D team should be prepared to work closely with customers to create new formulations or help to expand existing product lines offering suggestions as to what could be added to the dosage form in order to enhance its potential value to consumers. They should be experienced in product development, blending, packaging and agglomeration.It is important to work with a manufacturer that is familiar with the different materials and how they might react with one another so that product integrity can be preserved. This is especially important as nutritional supplements consist of more complex formulas with multiple ingredients.
Substitution of Cheaper Compounds
Stringent manufacturing practices are useless if the nutrients cannot be easily absorbed by the body. Some supplement manufacturers may substitute cheaper compounds. A client should make sure that more absorbable compounds are being used rather than the less absorbable ones. For example, many calcium formulas include magnesium; well-absorbed forms include magnesium aspartate, magnesium glycinate and magnesium oxide. Many other minerals may be complex as aspartates