Difficulties You may Encounter From a health supplement Manufacturer
Low quality Control
Poor quality Control
A number, mis-labeling, super-potency, sub-potency, and dissolution failure of other issues continue to plague nutraceutical companies.Unlike synthesized products, quality control poses special challenges for a natural product. Often, with no extensive method development and research, it is not possible to validate the marker compound levels against the label claim (i.e. Supplement Facts Label). This’s very true when the compounds found in 2 or perhaps more of the botanicals are in the same category. When a product contains a mixture of 10 botanicals which are not standardized extracts it is still more difficult.
Also, lots of botanical constituents will bind to excipients to some amount, making complete extraction difficult. And, once obtained from the botanical, lots of constituents will start to degrade rapidly making verification difficult, if not impossible.Clients that have developed dietary product formulas should look into establishing a partnership with an independent laboratory which has experience in analytical method growth and validation for products which are natural. By supplying the laboratory with a sample of each and every raw compound used in production, the lab is able to make controlled mock ups of the formulation and compare them to the finished dosage product. In addition, the laboratory is able to test each one off ingredient to see what it compares to the first supplier’s C of A. Contract labs offer self reliant verification of the product’s quality. This is now progressively more important in today’s industry.
Another aspect to quality control is batch lot testing which ensures quality control at the first level. The potency and purity of herbs is determined by the quality of the raw herb used and the care taken in manufacturing. The NNFA GMP routine mandates that almost all botanical raw materials be batch lot analyzed for identity every time. They need this in addition to a selection of alternative protocols because of the known lot-to-lot variations which occur in agricultural products.In order to save costs on an independent laboratory analysis of the finished product, product manufacturers could question their client to depend solely on their production records to show that a certain production run was properly prepared.
Their records mixed with analytical testing of the new raw materials, may suffice to meet the needs of the clients of theirs. But trends are changing. Quality Control has grown to be extremely important.If there aren’t any quality control measures established as well as a customer survey reveals the label potency assertions don’t match real potency of the item, consumer confidence is lost. to be able to avoid this particular circumstance, it’s important for customers to grow quality management methods early & demand for weight loss benefits (www.globenewswire.Com) analytical reports from third party labs which show that their supplements are fulfilling label statements before they accept shipment away from the dietary supplement supplier.
Non-Compliance to GMP standards
Non-Compliance to GMP standards
Numerous companies annually have products recalled because of an absence of GMP protocols in their facility. Poor-quality goods are a problem. Consequently, individuals will not continue to buy ineffective products. The nutritional supplement industry has begun to call for Good Manufacturing Practices (GMPs) on a voluntary and self-enforced basis. Make sure the supplement manufacturer of yours is GMP compliant as well as adhering to its policies. While the FDA has yet to finalize the nutritional supplement industry GMPs which were mandated in the 1994 DSHEA act, pharmaceutical GMPs have been in place for some time.
New Research and Development Department
Substitution of Cheaper Compounds
Inadequate Facility
Communication
Trust
Mis-Labeling of Health Supplements