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Certificates of Analysis

Certificates of Analysis

An average Watson premix undergoes more than 45 physical and chemical tests by validated analytical procedures prior to being released for shipment to our customers.

Each Certificate of Analysis (C of A) Contains:

  • Unique Lot Number
  • A complete listing of the product’s tested physical and chemical specifications
  • Units of measure, if applicable
  • The minimum, maximum, and target specifications
  • The actual assay results from the assayed production lot
  • Manufacture date
  • Expiration date
  • Date the C of A was issued
  • Signature of authorized analytical chemist

Other information may be included upon customer request. Examples include customer specification number and customer purchase order number.

Watson assays several samples for each production lot. Actual results are checked by two analytical chemists prior to the Certificate of Analysis being signed.

 

Importance of a Certificate of Analysis

Of all efforts that a company undertakes, quality control may be the most important. In the nutritional industry, effective quality control is essential. When a product contains lower nutrient levels than stated on the label, it is evident that quality control procedures are failing.

Some companies report “Audit” in place of actual assay data. This means that batch records and supporting documentation were reviewed and that the correct amount of that nutrient should therefore be in the final blend. Reporting “Audit” as a result means that no actual assay was conducted. Certificates reporting “Audit” are generally called Certificates of Compliance (C of C). They are not true Certificates of Analysis. Audited results are sometimes offered in the industry in place of true assay results to save costs. However, audits will not catch a homogeneity problem, reactions between raw materials, or raw material potency issues.

Why You Should Insist on a Certificate of Analysis Supported by Analytical Data

  • Performing analytical tests is the only way to guarantee that a product meets customer specifications. C of A’s which report “Audit” in place of key results have no analytical data to support that an item meets specification.
  • You have the assurance that the premix meets your specification before it is added to your product. It is not uncommon, based on typical use rates, for 1000 pounds of premix to be used to produce over 1 million consumer units of finished product. One lot of out-of-spec premix can affect an enormous amount of finished consumer product.
  • The FDA and many consumer groups are becoming far more aggressive in taking retail products off shelves and testing them against label claim. The incidences of products not meeting label claim are the subject of many news articles, bulletins, and consumer advisory panels. A correctly formulated premix with a Certificate of Analysis is your best assurance that your product will meet label claim if tested.
  • The costs for assay-verified ingredients with assured potency is the investment required for superior manufacturing. Requiring assay verification on your nutritional ingredients is part of your overall quality program, your company’s SOPs, GMPs, ISO certification, and HACCP.

Our Certificate of Analysis is critical in assuring that your product will meet label claim.

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