Setting Specifications: Why It Matters

Setting specifications for raw materials and finished goods is one of the most important steps in protecting your business. FDA 21 CFR Part 111 requires manufacturers to establish specifications for identity, purity, strength, and composition for every component and finished product.

Too often, manufacturers focus on production and brand holders focus on marketing, leaving the quality team and specifications as an afterthought. That approach can lead to costly problems later. When specifications are unclear or test methods are not chosen upfront, finished products can fail label claims, causing delays, rework, and additional testing costs.

Start Early and Involve the Right People

The best time to set finished product specifications is during the research and development stage. Meeting Good Manufacturing Practice (GMP) requirements and following FDA regulations requires planning, so starting early is essential. Involving your lab at this early stage ensures you select scientifically valid methods and avoid surprises later.

When sourcing ingredients, include both the lab and purchasing in the conversation. This allows the lab to help determine the appropriate test methods and purchasing to know the best material to buy. If a United States Pharmacopeia (USP), Food Chemicals Codex (FCC), or AOAC International (AOAC) method is available, identify it upfront. This creates a strong foundation and helps prevent failures during production and release.