Standards and regulations related to pharmaceutical temperature-controlled packaging

The growing number of temperature-sensitive products and the globalization of manufacturing sites increase the complexity of distribution. During the past 10 years, cold chain actors have continuously worked to define and harmonize best practices.

Regulations have also followed this trend and increasingly focus on temperature-sensitive products.

You will find hereafter a selection of useful resources related to cold chain regulations and recommendations from professional parties.

Regulations

EU: Guidelines on Best Practices of Medicinal Products Distribution for Human Use (94/C 63/03 - in accordance with European Directive 92/25/EEC).

In the US, the shipment of temperature-sensitive articles is regulated by the Food and Drug Administration (FDA). According to the Code of Federal Regulation (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."

Standards, Recommendations and Good Practices

Standard NF S-99-700: Isothermal and refrigerating containers for health products - Thermal performance qualification methods.

AFF / SFSTP: Practical Guide 2008 - Cold Chain for Medicines.

ISTA 5B and 7D: Focused Simulation Guide for Thermal Performance Testing of Temperature Controlled Transport Packaging.

PDA (Parental Drug Association): Technical Report 39: Guidance for Temperature Controlled Medicinal Products: Maintaining the Quality of Temperature Sensitive Medicinal Products through the Transportation Environment.

WHO (World Health Organization): Guidelines on the international packaging and shipping of vaccines.

IATA: Perishable Cargo Regulation (PCR) Manual Chapter 17.

US Pharmacopia: Chapter 1079.