Skip to content

FDA and ICH Cold Chain Regulations

  • News

Headquarters of the U.S. Food and Drug Administration.Are you staying compliant? Here’s how FDA and ICH regulations apply to the cold chain. Marathon Products’ data loggers ensure metrics for government compliance are always at hand, leaving you with accurate data and peace of mind.

Key Takeaways:

  • FDA and ICH cold chain regulations affect U.S. manufacturers at home and abroad
  • Digital data loggers can help you measure the critical metrics for FDA and ICH compliance

Temperature control is paramount for companies in the cold chain industry. Failing to maintain the right conditions can impact the integrity and effectiveness of products such as vaccines, leading to life-threatening consequences for the people these products are supposed to help.

With this in mind, the U.S. Food and Drug Administration (FDA) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) have established guidelines to ensure companies adhere to the highest product storage and handling standards. Read on to learn how they apply to the cold chain.

FDA regulations for cold chain

Documentation is a crucial aspect of FDA compliance in the cold chain industry. Stakeholders also need a thorough understanding of the conditions and parameters governing the products they are responsible for. Here are the three principal FDA regulations for cold chain that you should know.

Drug sample storage and handling requirements

Regulation 21 CFR 203.32 stipulates that manufacturers and distributors in the cold chain should maintain drugs under stable conditions to ensure their effectiveness and integrity. This means the prevention of drug adulteration, deterioration, or contamination. Manufacturers and distributors of pharmaceutical products must comply with compendial and labeling requirements when handling drug samples.

Record keeping

Regulation 21 CFR 203.36 outlines the responsibilities of maintaining records, reports, and forms documenting requirement compliance. The burden of responsibility for recordkeeping falls on manufacturers and distributors and not on any third-party service being used for drug distribution, record keeping, or meeting PDA/PDMA requirements.

Distribution procedures

Regulation 21 CFR 211.150 requires manufacturers and distributors to establish written procedures for managing expiration dates. They must follow the First Expired, First Out (FEFO) principle to ensure drugs with the shortest expiration dates are used first.

Manufacturers and distributors must establish an identification system for distributed drug samples to facilitate recalls. The system should provide comprehensive records showing where drug samples were shipped for easy tracking.

The FDA regularly audits manufacturers and distributors in the cold chain industry to ensure they’re using scientifically sound standards, testing procedures, and sampling plans. Audits focus on operational and management procedures, personnel training, and temperature-controlled transport and storage.

ICH guidance

The ICH guidance provides recommendations for creating accurate tests to protect drug samples during storage and shipping. It considers the real-world shipping environment, including storage and transport durations, types of containers, seasons, and climate. By doing so, ICH guidelines help companies in the temperature-controlled supply chain meet technical FDA and international compliance requirements.

FDA and ICH compliance requires meticulous temperature monitoring, ongoing record-keeping, and stress testing. These controls ensure that cold chain logistics don’t cause life-threatening consequences to the end user.

Temperature monitoring

Temperature control is crucial in the cold chain industry due to the many temperature-sensitive drugs involved. An easy example of drugs with temperature constraints are the Moderna and Pfizer vaccines. The Moderna vaccine requires frozen storage between -50°C and -15°C throughout its lifecycle. On the other hand, the Pfizer vaccine requires frozen storage of between -90°C and –60°C (colder than winter in Antarctica).

These extreme distribution and storage conditions present a complex challenge for companies transporting and warehousing medicine.

Cold chain logistics providers must have top-of-the-range vaccine storage equipment to maintain required temperature ranges. Storage units must be large enough to store inventory without crowding. Additionally, they should be a backup system to preserve temperature integrity during power outages.

Each storage unit should have a digital data logger to continuously monitor and record temperature conditions. Digital data loggers provide temperature details of a preset recording interval, including how long the unit has operated outside the specified range. They also have massive storage capabilities and can store many years’ worth of temperature logs.

In addition to integrating digital data loggers into their systems, companies in the cold chain industry should conduct physical temperature checks at least twice a day. This helps confirm that storage units are working as they should and that the doors are closed to prevent temperature interference.

Ambient room temperature can play a crucial role in determining a vaccine’s viability, so it’s a good idea to include it in temperature documentation. As a rule of thumb, logistic providers in the cold chain should contact manufacturers immediately when a product is exposed to temperature conditions outside the recommended range to determine the drug’s efficacy.

Documentation and stress testing

To comply with FDA regulations, companies in the cold chain must provide detailed documentation of their operating environments. The documentation should include stability data, climatic zone and geographic data for transport and warehousing, and storage and shipping durations at all points along the cold chain. In addition, logistics providers should have detailed contingency plans for events such as power outages and out-of-range temperature variations.

Stress testing is essential for determining the efficacy of storage and transport procedures. It’s also important for operational continuity and staff training. Ultimately, documentation and stress testing aim to prove to the FDA that your product can reach the end consumer safely, with its efficacy intact.

How Marathon Products aids you with FDA and ICH compliance

Quality and documentation are essential when it comes to FDA and ICH compliance in the cold chain industry. Requirements can be extremely complex, and with several temperature-sensitive products, temperature recordings must be accurate to the last decimal. Digital data loggers can help you become compliant.

At Marathon Products, we pride ourselves as manufacturers of the best-in-class data loggers. In our 30 years of producing temperature monitoring devices, we have perfected our craft, bringing you the highest quality data loggers in the market. Our data loggers can measure temperature, CO2, vibration, and other key compliance metrics. Browse our catalog of products or call us at (800) 858-6872 for all your inquiries.

Back To Top