Get a sample of the raw material, a copy of the raw material Certificate of Analysis (CoA), and copy of the raw material specification sheet.

Quality will need to verify the sample raw material against the CoA to ensure the sample meets product specifications. Oftentimes, this includes quantitative testing in addition to physical testing.

Have the vendor complete vendor qualification survey (or equivalent).

Quality: What standard operating procedures (SOPs) does it have in place? What does its organizational structure look like? How large or developed is its quality team? Is it up to speed on food, drug, cosmetic, and dietary supplement GMPs (good manufacturing practices)? Does it have the proper documents relating to organic, Kosher, Halal, non-GMO (genetically modified organisms), etc.? How does it label, handle and store allergen-containing ingredients?

Supply Chain: What does the supply chain look like? What are the typical lead times? If an orders doubles, or grows exponentially, can this company continue to meet supply? Where are its distribution centers located? Are seasonality issues related to the ingredient that will impact delivery dates?

Business Risk: How long has the company been in the industry? What type of product liability insurance does it have? What is its return policy? Is this a company that will stand behind the quality of the products they sell?

Transparency: Ingredient brokers (and many ingredients are distributed by brokers) may not list the actual manufacturer on the CoA? If substitutions are made, how will this be communicated? Though FDA doesn’t specifically state in their GMPs that CoAs require the actual manufacturer of the ingredient to be listed, more auditors are looking for this type of information to ensure the quality and consistency of the raw materials.

Quality: What is the process for approving new raw materials? Does it maintain vendor qualification surveys or do site audits? Supply Chain

Supply Chain: Does it have secondary or back-up sources for raw materials? If volume significantly increases, can the contract manufacturer’s vendors handle the increase? How does it measure how well its suppliers are doing? Does it provide “vendor report cards” or similar feedback?

Business Risk: Who is responsible if it’s determined that a raw material causes a product recall?

Transparency: Some contract manufacturers will disclose which vendor they are using for their raw materials, and some contract manufacturers may not. However, if a brand owner specifies the use of a certain raw material (either a branded ingredient or from a specific vendor), the contract manufacturer should be able honor that request and show the appropriate documentation (for example, provide a copy of the CoA for that particular ingredient).