Product: Product Validation Program

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To develop cost effective, efficient programs to validate product label claims and quality.

Aesthetics aside, when a customer purchases a product there are certain claims made in the labeling, that lead the customer to purchase the product. The typical claims made on a drug related product are:

There are also a number of intrinsic and extrinsic attributes and/or conditions that need to be adhered to for the claims to be valid. Some extrinsic conditions are production process, handling, shipping, and storage conditions and temperatures, lighting and reconstitution state for products such as lyophilized powders. The typical intrinsic attributes are formulation, raw material (e.g., recombinant vs synthesized), and container closure system. It is incumbent upon the producer of the product to ensure the claims are valid given all the intrinsic and extrinsic attributes. This can be a very time consuming and costly endeavor, if not approached with great care and planning.

Given the variety of products in the compounding and hospital markets, validating claims can be a daunting and expensive task. DYNALABS works closely with the customer to develop efficient, cost effective programs to validate the claims made on their products. The program is divided into two segments. The first is to verify the product meets its label claim for ingredient(s), strength, and physical attributes. The second is to validate that the strength and physical attributes are maintained out to and including the claim Beyond Use Date (BUD) / Expiration Date (ED). The process for developing these programs is as follows: