The US Food and Drug Administration (FDA)
The US FDA, the American agency for food and drugs, is a US government agency. Below are a few of its responsibilities:
- It is in charge of pharmaceutical watch, studies and inspection, and of the regulations covering health products before they are put on the market.
- It is in charge of protecting public health.
- It guarantees the safety and effectiveness of drugs (human and veterinary), biological products, medical systems, food supplies, cosmetics and radiation emitting products.
- It issues regulations that include product approvals, the issue of manufacturing licenses, supply chain safety, manufacturing standards, and test methods.
- It prepares guides for industry (and other stakeholders) on manufacture, test, inspection and application policies. These guides show how to reach the regulatory objectives.
The FDA publishes over 100 draft texts and guides every year. Level 1 guides explain the new significant requirements, describe major changes in FDA interpretation, and cover complex issues. Level 2 guides cover existing practises or minor changes to regulations.
Recently, the new accent put on room temperature packaging requirements created interest in new forms of drug protection for drugs that previously did not require these types of measure.
The FDA regulates the shipping of heat sensitive products
Under FDA regulations, the use of temperature controlled packaging has become unavoidable when transporting heat sensitive products. According to the Code of Federal Regulations (CFR) Title 21, Section 211.94 (b): "Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product."
For diagnosis samples and infectious materials: "Special packaging (a triple packaging consisting of a primary receptacle, a secondary packaging, and an outer packaging) is required to transport diagnosis samples" (Section 49 CFR part 173.199 and 173.196)
Thanks to its tool-free manufacturing process, Sofrigam is able to provide solutions compliant with the regulations applicable anywhere in the world. It is an extremely flexible manufacturing method. Further, insulated polyurethane packaging has excellent insulation properties.
Thus, Sofrigam meets the most complex specifications and designs to-measure solutions depending on the pharmaceutical products to transport. All Sofrigam packaging is tested, qualified, and validated by its partner the Ater Métrologie laboratory.