Why is certificate of analysis important

It is also a good idea to request multiple preshipment samples from different lots for testing when qualifying a new ingredient. This is especially important when dealing with botanical products, as numerous factors can impact the final chemical and physical properties of the plant.

For instance, the color of echinacea can be green, yellow, or brown depending on the harvesting stage and drying process. Establishing a history with a supplier allows you to see how these variations may or may not fall within the specifications outlined in the C of A.

Practical preshipment examination of the real lot sample before each purchase may save you time and the cost of rejecting the whole shipment when a problem exists. Once a vendor is qualified and material is received, correct and clear information needs to be communicated on the product itself; this information must match the C of A exactly to certify the reliability of this document, almost like a reverse check for the document.

For example, container labels must match the C of A precisely, particularly for product name, vendor item number, and lot number. The use of bar codes on labels is especially convenient, because it allows you to track the inspection of the product as it was being manufactured, analyzed, and packed.

A visual inspection of the contents of the containers should then verify the consistency of color, odor, and appearance, and reveal any significant deviation or contamination. Finally, scientific sampling procedures should be followed to allow representative samples to be collected for proper examination of the product itself.

If a nonrepresentative sample is taken from the product, you cannot ensure that the entire batch of product sent truly matches that C of A. The final stage in the certification process is to conduct a firsthand laboratory analysis of the product itself. If a different assay is required, this should be communicated to your vendor prior to C of A submission, as assay methodology can change the outcome of the data.

The lab analysis can be conducted in-house, if you have the facilities, or can be conducted by outside laboratories. Primary lab analysis is also the best way to ensure that a material meets your quality standards. The simplest way is to build a reference sample library and compare each lot of the same item to the reference through visual and other simple examinations.

This will lay the groundwork for quality assurance for your products because your raw materials are now coming from a trustworthy source with consistently reliable documentation.

With this solid foundation, you will be able to work through your production quality system to bring the highest-quality products to your customers, building further trust in your product line. The Importance of a Trustworthy Certificate of Analysis.

April 21, Tang S. Related Content: Regulatory. Ingredients by Nature announces latest patent approval for eriocitrin to support blood glucose levels. It is important to consider the COA cycle as it applies to manufacturing. Below is a simple diagram demonstrating how COAs from incoming product- to processing- to testing-to shipping.

As we can see, COAs can be involved in the entire supply chain. Details to consider: When a product must meet X requirements, this can be microbiological for Food Safety, and Performance product quality For Micro this can be costly, and the supplier may not do this or will charge the customer additional fees for it.

Depending on the significance of the customer relationship, a supplier may choose to absorb the additional cost. Find out the best solution for your company by taking the Needs Assessment below! What makes up a COA document? These include; Supplier Information: This section contains data regarding the material supplier, including their name, address, and other contact information. Materials Identification: The content in this section identifies the material being verified by this COA.

And it usually contains common terms such as lot numbers, product codes and descriptions. This content is provided to meet shipping requirements and to help the receiver in confirming the material is authorized and its delivery is anticipated. It states the specific characteristics, test results or other evidence in terms of industry standards, regulatory requirements or customer-specific request. In some cases, the performance standards expected will also be noted for reference.

Signature Data: This last section of the COA includes a signature indicating that the evidence presented was reviewed by a qualified and authorized product inspector. What are COAs used for? Why does your company need to produce COAs? These include, but are not limited to; Decreased confidence in what gets shipped out Increase in product recalls, wasting company time and money Audit process becomes more complicated Competitors can get the edge when they produce COAs and you do not Lost customers The price of not having COAs is quite high, much higher than the cost to produce COAs in the first place.

How Should You Manage Them?