When it comes to regulatory bodies and concrete descriptions of how exactly you should be monitoring your environment . . . well it never comes to that.
Most regulatory bodies are vague in their recommendations for how you need to be monitoring your product’s temperature.
The FDA is no different.
However, there are some regulations out there that will help you avoid that dreaded FORM 483 from the FDA. In this edition of Dickson Translations we look to two FDA regulations and explain what they tell us about temperature monitoring in the food and pharmaceutical industries.
1. 21 CFR 110.80 – Food For Human Consumption
This section of the FDA’s Code of Federal Regulations speaks to the processes and controls associated with food for human consumption. It specifically states that ”Raw materials . . . shall be held at such temperature and relative humidity . . . to prevent the food from becoming adulterated…”
What it means: When storing the raw materials associated with food production, keep them at a safe temperature and humidity. Vague like most regulations, this FDA regulation does tell food producers something crucial: raw materials need to be monitored. This affects not only the manufacturer, but the supply chain that produces the raw materials for the manufacturer. It extends the reach of the FDA’s regulation of food.
2. 21 CFR 203.32 – Prescription Drug Marketing
This section of the FDA’s Code of Federal Regulations outlines the storage and handling requirements for drug samples. It states, ”Manufacturers, authorized distributors of record, and their representatives shall store and handle all drug samples under conditions that will maintain their stability, integrity, and effectiveness . . .”
What it means: All drug samples should be stored in proper conditions. It may sound strange to find a regulation on drug storage in a marketing regulation, but it sits there nonetheless. This regulation is important because it focuses on pieces of the supply chain that may normally go unnoticed. Drug samples are usually manufactured, stored, and shipped in much smaller quantities than entire batches of product. However, the FDA is stating that samples also must be stored under correct conditions. How do you prove you did that? With temperature monitoring.
Tags: 21CFR11, dickson translation, fda temperature, fda temperature guidelines, fda temperature monitoring