When manufacturing a healthcare product, controlling the quality of the raw materials used is as important as controlling the quality of your active pharmaceutical ingredients and your finished product. Managing your raw materials as part of your quality system will help to ensure that your finished healthcare product meets its quality attributes. It is wise to initiate such a system at the outset of product development and build it into the product design. Having this in place will help steer appropriate selection of the raw materials used.
With ASENAC, the following factors should be considered when we select the pharmaceutical raw material:
- Is there enough information to support the safety of the material selected (as well as its by-product[s])? For example, is the raw material commonly used in the regulated industry (that is, is it “generally recognized as safe” [GRAS] material)? Is it known to have toxicological concerns (for example, carcinogenetic potential)?
- Would the raw material lead to any pharmaceutical response or is it considered an inert substance? For pharmaceutical products, does it raise questions about interaction with your drug substance? For medical devices, does it change your product from a medical device to a combination product (which would lead to different regulatory requirements and pathways)? If yes, is there a different agent that could help you avoid a more difficult pathway?
- Is the supply of this material limited? If so, can it be replaced with another raw material? If not, it is critical to ensure the supply of this material (have a contract with the supplier or identify an alternate supplier) so that no shortages affect the manufacture of your healthcare product during clinical or commercialization phases.
- Is the material compatible with your finished product? For instance, in pharmaceutical products, the excipients can comprise more than 90% of a product’s weight. Therefore, evaluate the compatibility of the ingredients that may contribute to the quality (for example, hardness, dissolution rate) of the dosage form.
- Is the ingredient available as a pharmacopeia grade or medical grade? If it is, does it meet the requirements in the targeted jurisdiction? If not, can it be substituted by another ingredient?