Reference Guide: Key Regulations for Cold Chain

The movement and storage of temperature sensitive products defines the supply chain as a cold chain, a cool chain, or simply a temperature-controlled supply chain. With this definition comes the need for temperature to be consistently maintained and that the cold chain not be broken to ensure product quality is not compromised. This need for product quality, and the requirement for a dependable cold chain, can be illustrated with the Food and Pharmaceutical sectors, where not only are companies concerned with quality assurance, but also fall under the purview of federal regulatory and enforcement agencies to ensure public confidence. In the US, the federal regulatory agency is the US Food and Drug Administration (FDA), with other countries managing their own jurisdictions or share entities such as the ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)—with all agencies are mandated to ensure companies are compliant.

We’ve compiled the following list of regulations from various organization’s websites, for your convenience:

FDA regulations for cold chain

  • 21 CFR 205.50 Minimum requirements for the storage and handling of prescription drugs and for the establishment and maintenance of prescription drug distribution records.
    Refers to the minimum requirements for the storage and handling of drugs and specifically details the requirement for temperature recording and record keeping.
  • 21CFR 203.32 Drug sample storage and handling requirements.
    Refers to the need to maintaining the drugs under conditions to maintain stability, integrity and effectiveness as per the manufacture’s specifications
  • 21 CFR 203.36 Fulfillment houses, shipping and mailing services, comarketing agreements, and third-party recordkeeping.
    Refers to the responsibility for maintaining forms, reports and records used to meet requirements
  • 21 CFR 211.150 Distribution procedures.
    Refers to procedure of how drugs are to be distributed
  • 21 CFR Part 11 ELECTRONIC RECORDS, ELECTRONIC SIGNITURES
    Refers to the regulations and criteria in which the agency considers electronic records and signatures trustworthy
  • Food Safety Modernization Act (FSMA)
    Information on the Food Safety Modernization Act from CFSAN
  • Current Good Manufacturing Practices (CGMPs)
    Updates to Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
  • Foreign Supplier Verification Programs (FSVP)
    The FDA FSMA final rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals
  • Food Safety Plan Builder
  • HARPC
  • HACCP

CDC and Canadian Guidelines

European Commission

WHO – World Health Organization